SEC Form 10-Q filed by KalVista Pharmaceuticals Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
For the quarterly period ended
OR
For the transition period from to .
Commission File No.
(Exact name of registrant as specified in its charter)
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n/a
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Securities registered pursuant to Section 12(b) of the Exchange Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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As of August 29, 2025, the registrant had
Table of Contents
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Item 1. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
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July 31, |
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April 30, |
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2025 |
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2025 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Accounts receivable, net |
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- |
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Research and development tax credit receivable |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net of accumulated depreciation of $ |
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Right of use assets |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Lease liability - current portion |
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Deferred revenue |
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Total current liabilities |
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Long-term liabilities: |
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Lease liability - net of current portion |
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Royalty obligation |
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Total long-term liabilities |
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Stockholders’ equity |
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Common stock, $ |
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Shares issued and outstanding: |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Accumulated other comprehensive loss |
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( |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended |
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July 31, |
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2025 |
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2024 |
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Product revenue, net |
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$ |
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$ |
- |
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Operating expenses: |
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Cost of revenue |
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- |
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Research and development |
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Selling, general and administrative |
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Total operating expenses |
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Operating loss |
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( |
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( |
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Other income: |
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Interest income |
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Interest expense |
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- |
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Foreign currency exchange gain |
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Other income, net |
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Total other income |
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Loss before income taxes |
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( |
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Income tax expense |
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- |
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Net loss |
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$ |
( |
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$ |
( |
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Other comprehensive (loss) income: |
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Foreign currency translation loss |
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( |
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Unrealized holding gain on marketable securities |
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Reclassification adjustment for realized gain on marketable securities included in net loss |
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( |
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( |
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Total other comprehensive (loss) income |
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$ |
( |
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$ |
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Comprehensive loss |
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$ |
( |
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$ |
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Net loss per share, basic and diluted |
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$ |
( |
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$ |
( |
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Weighted average common shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statement of Changes in Stockholders’ Equity
(in thousands, except share amounts)
(Unaudited)
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Three Months Ended July 31, 2025 |
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Accumulated |
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Additional |
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Other |
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Total |
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Common Stock |
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Paid-in |
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Accumulated |
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Comprehensive |
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Stockholders’ |
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Shares |
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Amount |
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Capital |
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Deficit |
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Loss |
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Equity |
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Balance at May 1, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Issuance of common stock from equity incentive plans |
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— |
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— |
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— |
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Issuance of stock under the employee stock purchase plan |
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— |
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— |
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— |
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Release of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Foreign currency translation loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Unrealized holding gain from marketable securities |
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— |
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— |
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— |
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— |
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Reclassification adjustment for realized gain on available for sale securities included in net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance at July 31, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Three Months Ended July 31, 2024 |
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Accumulated |
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Additional |
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Other |
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Total |
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Common Stock |
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Paid-in |
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Accumulated |
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Comprehensive |
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Stockholders’ |
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Shares |
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Amount |
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Capital |
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Deficit |
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Loss |
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Equity |
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Balance at May 1, 2024 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Issuance of common stock from equity incentive plans |
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— |
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— |
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Release of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Foreign currency translation loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Unrealized holding gain from marketable securities |
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— |
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— |
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— |
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— |
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Reclassification adjustment for realized gain on available for sale securities included in net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance at July 31, 2024 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
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Three Months Ended |
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July 31, |
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2025 |
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2024 |
Cash flows from operating activities |
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Net loss |
$ |
( |
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$ |
( |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Stock-based compensation expense |
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Realized gain from sale of marketable securities |
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( |
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( |
Non-cash operating lease expense (benefit) |
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( |
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Amortization of premium on marketable securities |
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( |
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Foreign currency exchange loss (gain) |
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( |
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Non-cash interest expense and amortization of issuance costs |
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— |
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Fair value adjustment to derivative liability |
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— |
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Changes in operating assets and liabilities: |
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Research and development tax credit receivable |
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( |
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Accounts receivable, net |
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( |
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— |
Prepaid expenses and other assets |
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( |
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Accounts payable |
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Accrued expenses |
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( |
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( |
Deferred revenue |
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— |
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Net cash used in operating activities |
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( |
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( |
Cash flows from investing activities |
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Purchases of marketable securities |
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( |
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( |
Sales and maturities of marketable securities |
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Acquisition of property and equipment |
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( |
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( |
Capitalized website development costs |
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( |
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( |
Net cash provided by investing activities |
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Cash flows from financing activities |
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Proceeds from the royalty agreement |
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— |
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Issuance of common stock from equity incentive plans |
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Issuance of common stock from employee stock purchase plan |
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— |
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Net cash provided by financing activities |
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Effect of exchange rate changes on cash and cash equivalents |
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Net (decrease) increase in cash, cash equivalents and restricted cash |
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( |
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Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents and restricted cash at end of period |
$ |
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$ |
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Supplemental disclosures of non-cash activities: |
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Right of use assets obtained in exchange for operating lease liabilities |
$ |
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$ |
— |
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Reconciliation of cash, cash equivalents and restricted cash: |
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Cash and cash equivalents |
$ |
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$ |
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Restricted cash, long-term |
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— |
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Total cash, cash equivalents and restricted cash |
$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
Notes to the Condensed Consolidated Financial Statements (unaudited)
Company Background
KalVista Pharmaceuticals, Inc. (“KalVista” or the “Company”) is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet need. The Company has used its capabilities to develop sebetralstat, a novel, orally delivered, small molecule plasma kallikrein inhibitor targeting the disease hereditary angioedema (“HAE”).
On July 3, 2025, the U.S. Food and Drug Administration (the “FDA”) approved EKTERLY® (sebetralstat) for the treatment of acute attacks of HAE in adult and pediatric patients aged 12 years and older. The FDA approval was based on data from the phase 3 KONFIDENT clinical trial, published in the New England Journal of Medicine. Prior to the approval of EKTERLY, all on-demand treatment options approved in the U.S. required intravenous or subcutaneous administration, which carries a significant treatment burden. Even with the use of long-term prophylaxis, most people living with HAE continue to have unpredictable attacks and require ready access to on-demand medication.
The Company’s headquarters is located in Framingham, Massachusetts, with additional offices and research activities located in Cambridge, Massachusetts; Porton Down, United Kingdom; Salt Lake City, Utah; Zug, Switzerland; Tokyo, Japan; Berlin, Germany and Dublin, Ireland.
Liquidity
The Company has incurred operating losses since its inception. As of July 31, 2025, the Company had an accumulated deficit of $
In July 2025, the Company entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”) pursuant to which the Company is able to offer and sell, from time to time at its sole discretion, shares of its common stock with an aggregate offering price of up to $
The Company anticipates that it will continue to incur losses for the foreseeable future, and it expects those losses to increase as it begins to commercialize EKTERLY, continues to complete any post-approval regulatory obligations, and continues the development of potential additional product candidates. The Company may continue to incur substantial operating losses even as it continues to generate revenue from EKTERLY or its other products. The Company may seek to finance future cash needs through equity offerings, debt financing, corporate partnerships and product sales. The Company is subject to risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, and it may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The Company currently anticipates that, based upon its operating plans and existing capital resources, it has sufficient funding to operate for at least the next twelve months.
Change in fiscal year
On March 13, 2025, the Company's Board of Directors approved a change to the Company’s fiscal year end from April 30 to December 31, effective December 31, 2025, resulting in an eight-month transition period from May 1, 2025 to December 31, 2025. During the transition period, the Company has elected to file this Quarterly Report on Form 10-Q for the quarter ending July 31, 2025, and then will file quarterly reports based on the new fiscal year beginning with the quarter ending September 30, 2025, pursuant to Rule 15d-10(e)(2) of the Exchange Act.
Principles of Consolidation: The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial
7
position, results of operations, and cash flows. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements. There were no adjustments other than normal recurring adjustments. These unaudited interim condensed consolidated financial results are not indicative of any future annual or interim period. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the fiscal year ended April 30, 2025 in the Company’s Annual Report on Form 10-K filed with the SEC on July 10, 2025.
Segment Reporting: The chief operating decision maker, the CEO, manages the Company’s operations as a single operating segment for the purposes of assessing performance and making operating decisions.
Use of Estimates: The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Accounting estimates and management judgments reflected in the consolidated financial statements include: the accrual of research and development expenses, stock-based compensation, operating lease liabilities, product revenue reserve, interest expense on the Company’s royalty obligation, and assumptions used to value the embedded derivative in its royalty obligation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.
Recent Accounting Pronouncements: In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. The new guidance was effective for the Company as of May 1, 2024. The adoption of ASU 2023-07 resulted in additional disclosures but did not have a material impact on the Company’s consolidated financial statements. The Company adopted the reporting requirements in its 2025 Annual Report on Form 10-K for the fiscal year ended April 30, 2025 and began providing the interim reporting requirements in its Quarterly Report on Form 10-Q for the first quarter of 2026. Refer to Note 12, Segment Information, for further details on the Company’s segment information.
The Company does not expect any recently issued accounting standards other than those included in its Annual Report on Form 10-K for the fiscal year ended April 30, 2025 to have a material impact to its financial results.
The Company has included its accounting policies for accounts receivable, inventories, revenue recognition related to product sales, net, and cost of revenue as a result of the launch of EKTERLY in the U.S.
Accounts receivable, net: The Company’s trade accounts receivable arise from product sales and represent amounts due from specialty distributors and specialty pharmacy providers. The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in its customers’ credit profile. The Company reserves against these receivables for estimated losses that may arise from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve.
Inventory: The Company values inventory at the lower of cost or estimated net realizable value with cost determined on a first-in, first-out basis. Raw materials and work-in-process include all inventory costs prior to packaging and labeling, including raw material, active product ingredient, and the drug product. Finished goods include packaged and labeled products. At each reporting date, the Company evaluates the carrying value of inventory and provides valuation reserves for any estimated excess, obsolete, short-dated or unmarketable inventory. The Company’s inventory is subject to strict quality control and monitoring that is performed throughout the manufacturing process, including release of work-in-process to finished goods. In the event that certain batches or units of product do not meet quality specifications, the Company will record a write-down of any potential unmarketable inventory to its estimated net realizable value and record the expense as cost of revenue in the Consolidated Statements of Operations and Comprehensive Loss. Prior to obtaining initial regulatory approval for an investigational product candidate, costs relating to production of pre-launch inventory are expensed as research and development expense in the period incurred. After regulatory approval has been received inventory costs are capitalized.
Revenue recognition: The Company recognizes revenue from product sales when the customer obtains control of the Company’s product. The transaction price is the amount that reflects the consideration which the Company expects to receive. The Company estimates reserves for variable consideration related to applicable discounts, rebates, chargebacks and other allowances included in its agreements with customers, payors and other third parties. The Company includes the amount of variable consideration in the transaction price to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If actual results vary significantly from the Company’s estimates, the Company adjusts its estimates in the period that the Company becomes aware of such variances.
Cost of revenue: The Company's cost of revenue is comprised of costs related to its commercial revenue, including manufacturing costs and indirect costs associated with the manufacturing and distribution of its products. The Company also may include certain period costs related to manufacturing services and inventory adjustments in cost of revenue. Cost of revenue for EKTERLY does not currently
8
include the full cost of manufacturing until the Company manufactures and sells additional inventory after exhausting its pre-launch supply. Such pre-launch supply has previously been recorded as research and development expense.
The Company’s other significant accounting policies have not changed substantially from those included in the Company’s Annual Report on Form 10-K for the fiscal year ended April 30, 2025.
The following tables present information about financial assets and liability that have been measured at fair value and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value as of July 31, 2025 and April 30, 2025 (in thousands):
|
|
|
|
|
|
|
|
|
|
Balance at |
|
||||
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
July 31, 2025 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
U.S. government agency securities |
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Total financial assets |
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Liability: |
|
|
|
|
|
|
|
|
|
|
|
||||
Derivative liability |
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
Balance at |
|
||||
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
April 30, 2025 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
U.S. government agency securities |
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Total financial assets |
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Liability: |
|
|
|
|
|
|
|
|
|
|
|
||||
Derivative liability |
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
The objectives of the Company’s investment policy are to ensure the safety and preservation of invested funds, as well as to maintain liquidity sufficient to meet cash flow requirements. The Company invests its excess cash in securities issued by financial institutions, commercial companies, and government agencies that management believes to be of high credit quality in order to limit the amount of its credit exposure. The Company has not realized any material losses from its investments.
The Company classifies all of its debt securities as available-for-sale. Unrealized gains and losses on investments are recognized in accumulated comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are included in other income in the consolidated statements of operations and comprehensive loss and are determined using the specific identification method with transactions recorded on a trade date basis.
The estimated fair value of the derivative liability as of July 31, 2025 relates to the Purchase and Sale Agreement that the Company, as guarantor, and KalVista Pharmaceuticals Limited, a wholly owned subsidiary of the Company (the “Subsidiary”), entered into with DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust (“DRI”) in November 2024 (the “PSA”) and was determined using Level 3 inputs. Refer to Note 7, Purchase and Sale Agreement, for a description of the PSA. The fair value measurement of the derivative liability is sensitive to changes in the unobservable inputs used to value the financial instrument. Changes in the inputs could result in changes to the fair value of each financial instrument.
9
The embedded derivative liability associated with the royalty obligation contained in the PSA, as discussed further in Note 7, Purchase and Sale Agreement, is measured at fair value using an option pricing Monte Carlo simulation model and is included as a component of the royalty obligation on the consolidated balance sheet. The embedded derivative liability is subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of other income, net. The assumptions used in the option pricing Monte Carlo simulation model incorporates certain Level 3 inputs including: (1) the risk-adjusted discount rate and (2) the probability of a change in control occurring during the term of the instrument.
The Company recorded $
Marketable Securities
The following tables summarize the fair values of the Company’s marketable securities by type as of July 31, 2025 and April 30, 2025 (in thousands):
|
July 31, 2025 |
|
|||||||||||||
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
||||
Corporate debt securities |
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Obligations of the U.S. Government and its agencies |
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total |
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
April 30, 2025 |
|
|||||||||||||
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
||||
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
||||
Corporate debt securities |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Obligations of the U.S. Government and its agencies |
|
|
|
|
|
|
|
|
|
|
|
||||
Total investments |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table summarizes the scheduled maturity for the Company’s marketable securities at July 31, 2025 (in thousands):
|
July 31, 2025 |
|
|
Maturing in one year or less |
$ |
|
|
Maturing after one year through two years |
|
|
|
Maturing after two years through four years |
|
|
|
Total |
$ |
|
|
4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of July 31, 2025 and April 30, 2025 (in thousands):
|
|
|
July 31, |
|
|
April 30, |
|
|
|
2025 |
|
|
2025 |
Kaken receivable (Note 8) |
|
$ |
|
$ |
||
Other prepaid expenses |
|
|
|
|
||
Interest and other receivables |
|
|
|
|
||
VAT receivable |
|
|
|
|
||
Prepaid clinical activities |
|
|
|
|
||
Total prepaid expenses and other current assets |
|
$ |
|
$ |
10
5. Accrued Expenses
Accrued expenses consisted of the following as of July 31, 2025 and April 30, 2025 (in thousands):
|
|
July 31, |
|
|
April 30, |
|
||
|
|
2025 |
|
|
2025 |
|
||
Accrued compensation |
|
$ |
|
|
$ |
|
||
Accrued research expense |
|
|
|
|
|
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
||
6. Leases
The Company maintains leases for office space and research laboratory space, and as of July 31, 2025, all leases were classified as operating leases. These leases have remaining lease terms ranging from
Location |
|
Function |
|
Square footage |
|
Initial Lease |
|
Lease |
Framingham, MA |
|
Corporate Headquarters |
|
|
2035 |
|
||
Cambridge, MA |
|
Office Space |
|
|
2028 |
|
||
Salt Lake City, UT |
|
Office Space |
|
|
2032 |
|
||
Cambridge, MA |
|
Laboratory facility |
|
|
2028 |
|
||
Porton Down, UK |
|
Laboratory and office space facility |
|
|
2028 |
|
||
Dublin, Ireland |
|
Office Space |
|
|
2028 |
|
||
Tokyo, Japan |
|
Office Space |
|
|
2026 |
|
||
Zug, Switzerland |
|
Office Space |
|
|
2025 |
|
||
Berlin, Germany |
|
Office Space |
|
|
2026 |
|
Pursuant to the headquarter lease in Framingham that was signed in July 2024, but had not commenced as of July 31, 2025, the Company provided a security deposit in the form of a letter of credit in the amount of $
Total rent expense was approximately $
11
The following table summarizes the maturity of undiscounted payments due under lease liabilities and the present value of those liabilities as of July 31, 2025 (in thousands):
Years ending April 30, |
|
|
Operating |
2026 |
|
$ |
|
2027 |
|
|
|
2028 |
|
|
|
2029 |
|
|
|
2030 |
|
|
|
Thereafter |
|
|
|
Total minimum lease payments |
|
|
|
Less amounts representing interest |
|
|
|
Present value of minimum payments |
|
|
|
Current portion |
|
|
|
Long-term portion |
|
$ |
Total lease payments in the table above excludes approximately $
7. Purchase and Sale Agreement
Royalty Liability
In November 2024, the Company entered into the PSA pursuant to which it is potentially eligible to receive payments from DRI up to $
Beginning in calendar year 2031, the First Tier Royalty Rate for any calendar year will be determined based on annual net sales of sebetralstat for the prior calendar year:
As sebetralstat was approved prior to October 1, 2025, the Subsidiary elected to receive the one-time cash payment of $
On receipt of the $
The PSA is considered a sale of future revenues and is accounted for as long-term debt recorded at amortized cost using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. During the three months ended July 31, 2025, the Company recorded $
12
The PSA is denominated in US Dollars and was executed with the Company’s wholly owned U.K. Subsidiary, whose functional currency is the British Pound. As such, the Company will remeasure the liability each reporting period at current exchange rates and recognize unrealized gains and loss in other income.
Embedded Derivative Liability
Under the PSA, the Subsidiary has the option (the “Buy-Back Option”) to repurchase future Revenue Participation Rights at any time until December 31, 2026 either (i) in the event of a change of control of the Subsidiary or (ii) in the event that confirmation that payment of the Revenue Participation Rights will not receive certain tax treatment has not been obtained. Additionally, the Purchaser has an option (the “Put Option”) to require the Subsidiary to repurchase future Revenue Participation Rights in the event of a change of control of the Subsidiary exercisable until December 31, 2026. If the Put Option or the Buy-Back Option is exercised terminating the PSA, the required repurchase price is an amount equal to (a) 1.5 multiplied by (b) the Investment Amount, net of the sum of any payments received by the Purchaser prior to such Put Option or Buy-Back Option repurchase date, as applicable.
The Buy-Back and Put Options are considered embedded derivatives requiring bifurcation as a single compound derivative instrument. The Company estimated the fair value of the derivative liability using a “with-and-without” method. The with-and-without methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual embedded derivative. The difference between the entire instrument with the embedded derivative compared to the instrument without the embedded derivative is the fair value of the derivative liability.
The Company recorded $
The estimated probability and timing of underlying events triggering the exercisability of the Buy-Back and Put Options contained in the PSA, forecasted cash flows and the discount rate are significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative. Management concluded the buy-back option probability was in the lower quarter tile of possible outcomes. As of inception, the estimated market yield used for the valuation of the derivative liability was
8. License, Supply and Distribution Agreement
Kaken Pharmaceutical Co., Ltd. (“Kaken”)
In April 2025, the Company entered into a License, Supply and Distribution Agreement (the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”) pursuant to which the Company 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 $
Per the terms of the Kaken Agreement, the Company is responsible for obtaining and maintaining all regulatory approvals, performing regulatory submissions for the Licensed Product in Japan and supplying the Licensed Product to Kaken. Kaken received an exclusive license to commercialize the Licensed Product in Japan, including the right to ship, store, and distribute the Licensed Product for such commercialization during the term of the Kaken Agreement. The Company retains manufacturing rights for the Licensed Product and is responsible for the Company’s own costs associated with the performance of activities under the Kaken Agreement.
Under the terms of the Kaken Agreement, Kaken paid the Company a non-refundable upfront payment of $
The potential regulatory and sales milestone payments that the Company is eligible to receive will be recorded if and when they become probable.
13
Any future potential revenue from units sold to Kaken will be recorded in accordance with ASC 606, Revenue from Contracts with Customers.
9. Product Revenues and Accounts Receivable, net
The Company’s product revenue, net of sales discounts, allowances and reserves for the three months ended July 31, 2025 and 2024 were $
The Company had product sales to certain customers that each accounted for more than 10% of total gross product sales for the three months ended July 31, 2025.
|
Three Months Ended |
|
July 31, 2025 |
Customer A |
|
Customer B |
|
Customer C |
As of July 31, 2025, the Company’s accounts receivable, net were $
10. Net Loss per Share
Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the sum of the weighted average number of common shares and the number of potential dilutive common share equivalents outstanding during the period. Potential dilutive common share equivalents consist of outstanding options, unvested restricted stock units, unvested performance stock units, and shares committed to be purchased under the employee stock purchase plan.
Potential dilutive common share equivalents consist of:
|
|
July 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Stock options and awards |
|
|
|
|
|
|
||
In computing diluted earnings per share, common share equivalents are not considered in periods in which a net loss is reported, as the inclusion of the common share equivalents would be anti-dilutive. As a result, there is no difference between the Company’s basic and diluted loss per share for the periods presented.
11. Segment Information
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision-maker (“CODM”) in deciding how to allocate resources and assess performance. The Company operates in
The following table presents selected financial information with respect to the Company’s single operating segment for the three months ended July 31, 2025 and 2024 (in thousands):
14
|
|
Three Months Ended |
|||
|
|
July 31, |
|||
|
|
2025 |
|
|
2024 |
Product revenue, net |
$ |
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
Cost of revenue |
|
|
|
— |
|
Clinical development |
|
|
|
||
Research |
|
|
|
||
Regulatory & QA |
|
|
|
||
Pre-commercial planning |
|
|
|
||
Other SG&A |
|
|
|
||
Total operating expenses |
|
|
|
||
(Loss) income from operations |
|
( |
|
|
( |
Other income |
|
|
|
||
(Loss) income before income taxes |
$ |
( |
|
$ |
( |
Provision for (benefit from) for income taxes |
|
|
|
— |
|
Net loss |
$ |
( |
|
$ |
( |
12. Income Taxes
The provision for income taxes for the three months ended July 31, 2025 was $
15
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL 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.
16
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):
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
July 31, |
|
|
Increase |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
(Decrease) |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Product revenue, net |
|
$ |
1,426 |
|
|
$ |
- |
|
|
$ |
1,426 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Cost of revenue |
|
|
590 |
|
|
|
- |
|
|
|
590 |
|
Research and development expense |
|
|
15,162 |
|
|
|
26,614 |
|
|
|
(11,452 |
) |
Selling, general and administrative expense |
|
|
44,683 |
|
|
|
17,601 |
|
|
|
27,082 |
|
Other income: |
|
|
|
|
|
|
|
|
|
|||
Interest, exchange rate gain and other income |
|
|
1,070 |
|
|
|
3,772 |
|
|
|
(2,702 |
) |
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.
17
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):
|
|
Three Months Ended |
|
|
|
|
|
|
|||||||
|
|
July 31, |
|
|
Increase |
|
Percent |
|
|||||||
|
|
2025 |
|
|
2024 |
|
|
(Decrease) |
|
Change |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||
EKTERLY |
|
$ |
5,481 |
|
|
$ |
11,980 |
|
|
$ |
(6,499 |
) |
|
-54 |
% |
Personnel |
|
|
8,077 |
|
|
|
9,142 |
|
|
|
(1,065 |
) |
|
-12 |
% |
Other R&D |
|
|
1,604 |
|
|
|
5,492 |
|
|
|
(3,888 |
) |
|
-71 |
% |
Total |
|
$ |
15,162 |
|
|
$ |
26,614 |
|
|
$ |
(11,452 |
) |
|
-43 |
% |
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.
18
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):
|
|
Three Months Ended |
|
|||||
|
|
July 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
|
|
|
|
|||||
Cash used in operating activities |
|
$ |
(54,502 |
) |
|
$ |
(40,220 |
) |
Cash provided by investing activities |
|
|
21,261 |
|
|
|
37,162 |
|
Cash provided by financing activities |
|
|
23,210 |
|
|
|
3,000 |
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
2,723 |
|
|
|
117 |
|
Net (decrease) increase in cash, cash equivalents and restricted cash |
|
$ |
(7,308 |
) |
|
$ |
59 |
|
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.
19
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.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
Item 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of July 31, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute assurance of achieving the desired objectives. Also, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer has concluded that our disclosure controls and procedures were effective as of July 31, 2025.
Changes in Internal Controls over Financial Reporting
There have been no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended July 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
20
PART II
OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. We are currently not aware of any such legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results.
Item 1A. RISK FACTORS
There have been no material changes to the risk factors described in the section captioned “Part I, Item 1A, Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025.
In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section captioned “Part I, Item 1A, Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025 filed with the SEC on July 10, 2025, which may materially affect our business, financial condition, or future results. The risks described in our Annual Report on Form 10-K and in our Quarterly Reports on Form 10-Q are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may have a material adverse effect on our business, financial condition, or operating results.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Sales of Unregistered Securities
Not applicable.
Use of Proceeds
None.
Issuer Purchases of Equity Securities
Not applicable.
Item 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
Item 4. MINE SAFETY DISCLOSURES
Not applicable.
Item 5. OTHER INFORMATION
(c) Insider Trading Arrangements and Policies
In the first quarter of fiscal year 2026, no trading plans were
21
Item 6. EXHIBITS
|
|
Incorporated by Reference |
|
|||
Exhibit Number |
Exhibit Description |
Form |
File No. |
Exhibit |
Filing Date |
Filed Herewith |
31.1 |
|
|
|
|
X |
|
|
|
|
|
|
|
|
31.2 |
|
|
|
|
X |
|
|
|
|
|
|
|
|
32.1# |
|
|
|
|
X |
|
|
|
|
|
|
|
|
101.INS |
Inline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document. |
|
|
|
|
|
|
|
|
|
|
|
|
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
|
|
|
|
|
|
|
|
|
|
|
|
104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
|
|
|
|
|
† Registrant has omitted portions of the exhibit as permitted under Item 601(b)(10) of Regulation S-K.
^ Registrant has omitted schedules and exhibits pursuant to Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of the omitted schedules and exhibits to the SEC upon request.
# This certification is deemed not filed for purpose of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act.
22
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
KALVISTA PHARMACEUTICALS, INC.
|
|
|
|
|
Date: September 11, 2025 |
By: |
/s/ Benjamin L. Palleiko |
|
|
Benjamin L. Palleiko Chief Executive Officer (Principal Executive Officer) |
Date: September 11, 2025 |
By: |
/s/ Brian Piekos |
|
|
Brian Piekos Chief Financial Officer (Principal Financial and Accounting Officer) |
23