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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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
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(Registrant’s telephone number, including area code)
n/a
Former name, former address and former fiscal year, if changed since last report
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES NO
As of December 4, 2024, 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)
(Unaudited)
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October 31, |
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April 30, |
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2024 |
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2024 |
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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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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 |
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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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Total current liabilities |
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Long-term liabilities: |
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Lease liability - net of current portion |
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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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Six Months Ended |
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October 31, |
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October 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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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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( |
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( |
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Other income: |
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Interest income |
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Foreign currency exchange gain (loss) |
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( |
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Other income |
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Total other income |
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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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Other comprehensive (loss) income: |
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Foreign currency translation gain (loss) |
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( |
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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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( |
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( |
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Other comprehensive income (loss) |
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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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$ |
( |
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$ |
( |
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Net loss per share to common stockholders, basic and diluted |
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$ |
( |
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$ |
( |
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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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Six Months Ended October 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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( |
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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 marketable 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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Issuance of common stock from equity incentive plans |
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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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( |
) |
Foreign currency translation gain |
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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 marketable 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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( |
) |
Balance at October 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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5
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Six Months Ended October 31, 2023 |
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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, 2023 |
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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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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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( |
) |
Foreign currency translation gain |
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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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Reclassification adjustment for realized (gain) on marketable 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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( |
) |
Balance at July 31, 2023 |
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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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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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( |
) |
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 marketable 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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( |
) |
Balance at October 31, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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6
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
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Six Months Ended |
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October 31, |
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2024 |
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2023 |
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Cash flows from operating activities |
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Net loss |
$ |
( |
) |
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$ |
( |
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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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( |
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Non-cash operating lease (benefit) expense |
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( |
) |
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( |
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Amortization of premium on marketable securities |
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Foreign currency exchange (gain) loss |
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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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( |
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Prepaid expenses and other assets |
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Accounts payable |
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( |
) |
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Accrued expenses |
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Net cash used in operating activities |
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( |
) |
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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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( |
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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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( |
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Net cash provided by investing activities |
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Cash flows from financing activities |
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Issuance of common stock from equity incentive plans |
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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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( |
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Net increase in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents 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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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
Notes to the Condensed Consolidated Financial Statements (unaudited)
Company Background
KalVista Pharmaceuticals, Inc. (“KalVista” or the “Company”) is a clinical stage pharmaceutical company focused on the discovery, development and commercialization of drug therapies for 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”).
In February 2024, the Company announced topline data from the Phase 3 KONFIDENT clinical trial to evaluate the safety and efficacy of sebetralstat as potentially the first oral, on-demand therapy for HAE. KONFIDENT was the largest and most representative trial ever conducted in HAE, enrolling a total of
In June 2024, the Company filed a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) seeking marketing approval of sebetralstat as the first oral, on-demand therapy for HAE. In August 2024, the Company was notified that the FDA has accepted the NDA filing for review, with a Prescription Drug User Fee Act (“PDUFA”) notification date of June 17, 2025.
Also in August 2024, the European Medicines Agency (“EMA”) validated the submission of the Company's Marketing Authorization Application (“MAA”) for sebetralstat. This application is currently being reviewed by the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) under the centralized licensing procedure for all 27 Member States of the European Union, as well as the EEA countries Norway, Iceland and Liechtenstein. In September 2024, the Company announced MAA submissions to the regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore via the Access Consortium framework for which KalVista has obtained a four-way sharing agreement by the Medicines and Healthcare product Regulatory Agency, Swissmedic, the Therapeutic Goods Administration and Health Sciences Authority. The Access Consortium is designed to maximize regulatory collaboration across countries and support a timely review process. The Company also is preparing a planned Japanese New Drug Application (“JNDA”) filing with the Japanese Pharmaceuticals and Medical Devices Agency.
The Company’s headquarters is currently located in Cambridge, Massachusetts, with additional offices and research activities located in Porton Down, United Kingdom; Salt Lake City, Utah; Zug, Switzerland; and Tokyo, Japan.
In July 2024, the Company entered into a new headquarters lease for approximately
Liquidity
The Company has devoted substantially all of its efforts to research and development, including preclinical and clinical trials of sebetralstat. The Company has not completed the development of any product candidates or commenced commercial operations. Pharmaceutical drug product candidates, like those being developed by the Company, require approvals from the FDA or foreign regulatory agencies prior to commercial sales. There can be no assurance that any product candidate will receive the necessary approvals and any failure to receive approval or delay in approval may have a material adverse impact on the Company’s business and financial results. The Company is subject to risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of a late-stage product candidate; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; the challenges of protecting and enhancing intellectual property rights; and complying with applicable regulatory requirements.
8
To date, the Company has not generated any product sales revenues and does not have any products that have been approved for commercialization. As of October 31, 2024, the Company had an accumulated deficit of $
The Company may seek to finance future cash needs through equity offerings, debt financing, corporate partnerships and product sales. In the event of failure to obtain regulatory approval for product candidates, the Company will not be able to generate product sales, which will have a material adverse effect on the business and prospects.
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 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 necessarily indicative of the results to be expected for the year ending April 30, 2025, or for any other 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 year ended April 30, 2024 in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on July 11, 2024.
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 condensed 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 condensed financial statements and the reported amounts of expenses during the reporting period. Accounting estimates and management judgments reflected in the condensed financial statements include: the accrual of research and development expenses, stock-based compensation, and operating lease liabilities. 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 2024, the Financial Accounting Standards Board (“FASB”) issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures, which requires public business entities to disclose, on an annual and interim basis, disaggregated information about certain income statement expense line items. The required information includes purchases of inventory, employee compensation, depreciation, intangible asset amortization and depletion. The standard will be effective for the Company beginning with annual financial statements for the fiscal year ending April 30, 2028. The Company has not yet determined the impact of adopting this guidance on its financial statements.
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. ASU No. 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. Early adoption is permitted, and the amendments should be applied retrospectively. The Company does not expect the amendments in this ASU to have a material impact on its consolidated financial statements.
9
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company does not expect the amendments in this ASU to have a material impact on its consolidated financial statements.
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:
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October 31, |
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2024 |
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2023 |
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Stock options and awards |
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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.
The weighted average number of common shares used in the basic and diluted net loss per common share calculations includes the weighted-average pre-funded warrants outstanding during the period as they are exercisable at any time for nominal cash consideration.
Fair Value Measurement: The Company classifies fair value measurements using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1, quoted market prices in active markets for identical assets or liabilities; Level 2, observable inputs other than quoted market prices included in Level 1, such as quoted market prices for markets that are not active or other inputs that are observable or can be corroborated by observable market data; and Level 3, unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs. These fair values are obtained from independent pricing services which utilize Level 1 and Level 2 inputs.
The following tables summarize the cash equivalents and marketable securities measured at fair value on a recurring basis as of October 31, 2024 and April 30, 2024 (in thousands):
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Balance at |
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Level 1 |
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Level 2 |
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Level 3 |
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October 31, 2024 |
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Cash equivalents |
$ |
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$ |
— |
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$ |
— |
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$ |
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Marketable securities: |
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Corporate debt securities |
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— |
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— |
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U.S. government agency securities |
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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 |
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Level 1 |
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Level 2 |
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Level 3 |
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April 30, 2024 |
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Cash equivalents |
$ |
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$ |
— |
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$ |
— |
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$ |
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Marketable securities: |
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Corporate debt securities |
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— |
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— |
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U.S. government agency securities |
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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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10
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 following tables summarize the fair values of the Company’s investments by type as of October 31, 2024 and April 30, 2024 (in thousands):
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October 31, 2024 |
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Amortized |
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Unrealized |
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Unrealized |
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Estimated |
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Cost |
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Gains |
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Losses |
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Fair Value |
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Corporate debt securities |
$ |
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$ |
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$ |
( |
) |
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$ |
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Obligations of the U.S. Government and its agencies |
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— |
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Total |
$ |
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$ |
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$ |
( |
) |
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$ |
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April 30, 2024 |
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Amortized |
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Unrealized |
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Unrealized |
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Estimated |
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Cost |
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Gains |
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Losses |
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Fair Value |
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Corporate debt securities |
$ |
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$ |
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$ |
( |
) |
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$ |
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Obligations of the U.S. Government and its agencies |
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( |
) |
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Total |
$ |
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$ |
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$ |
( |
) |
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$ |
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The Company has classified all of its available-for-sale investment securities, including those with maturities beyond one year, as current assets on its condensed consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations.
As of October 31, 2024, unrealized losses related to individual securities that had been in a continuous loss position for 12 months or longer were insignificant.
The Company has
The following table summarizes the scheduled maturity for the Company’s marketable securities at October 31, 2024 (in thousands):
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October 31, 2024 |
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Maturing in one year or less |
$ |
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Maturing after one year through two years |
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Maturing after two years through four years |
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Total |
$ |
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11
4. Accrued Expenses
Accrued expenses consisted of the following as of October 31, 2024 and April 30, 2024 (in thousands):
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October 31, |
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April 30, |
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2024 |
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2024 |
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Accrued compensation |
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$ |
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$ |
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Accrued research expense |
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Accrued professional fees |
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Other accrued expenses |
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$ |
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$ |
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5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of October 31, 2024 and April 30, 2024 (in thousands):
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October 31, |
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April 30, |
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2024 |
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2024 |
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Prepaid preclinical and clinical activities |
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$ |
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$ |
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Other prepaid expenses |
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Interest and other receivables |
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VAT receivable |
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Total prepaid expenses and other current assets |
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$ |
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$ |
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6. Commitments and Contingencies
Clinical Studies: The Company enters into contractual agreements with contract research organizations in connection with preclinical and toxicology studies and clinical trials. Amounts due under these agreements are invoiced to the Company on predetermined schedules during the course of the studies and clinical trials and are not refundable regardless of the outcome. The Company has contractual obligations related to the expected future costs to be incurred to complete the ongoing preclinical studies and clinical trials. The remaining clinical commitments, which have cancellation provisions, total $
Indemnification: In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations.
Contingencies: From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There were
7. Leases
The Company has a lease agreement for approximately
In July 2024, the Company signed a new headquarters lease for approximately
In September 2024, the Company signed a new lease for office space in Zug, Switzerland for approximately
The Company has lease agreements for approximately
12
The Company has a lease agreement in Salt Lake City, Utah for approximately
The Company has a lease agreement for approximately
Total rent expense was approximately $
The following table summarizes the maturity of undiscounted payments due under lease liabilities and the present value of those liabilities as of October 31, 2024 (in thousands):
Years ending April 30, |
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Operating |
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2025 |
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$ |
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2026 |
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2027 |
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2028 |
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2029 |
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Thereafter |
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Total minimum lease payments |
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Less amounts representing interest |
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Present value of minimum payments |
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Current portion |
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Long-term portion |
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$ |
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|
Total lease payments in the table above excludes approximately $
8. Subsequent Events
Royalty Financing
On November 4, 2024, the Company, as guarantor, and KalVista Pharmaceuticals Limited, a wholly owned subsidiary of the Company (the “Subsidiary”), entered into a Purchase and Sale Agreement with DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust, for 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:
If sebetralstat is approved prior to October 1, 2025, the Subsidiary will have the option to receive a one-time cash payment of $
Underwriting Agreement
On November 4, 2024, the Company entered into an underwriting agreement with Jefferies LLC, BofA Securities, Inc., TD Securities (USA) LLC, and Stifel, Nicholas & Company Incorporated, as the representatives of the several underwriters named in Schedule A thereto (the “Underwriters”), pursuant to which the Company agreed to issue and sell an aggregate of
13
Securities Purchase Agreement
On November 4, 2024, the Company entered into a securities purchase agreement with DRI Healthcare Acquisitions LP, an accredited investor affiliated with DRI Healthcare Trust, pursuant to which the Company agreed to sell and issue an aggregate of
14
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 clinical stage pharmaceutical company focused on the discovery, development and commercialization of drug therapies for diseases with significant unmet need. We have used our capabilities to develop sebetralstat, a novel, orally delivered, small molecule plasma kallikrein inhibitor targeting the disease hereditary angioedema (“HAE”).
HAE is a rare and potentially life-threatening, genetically driven disease that features episodes of debilitating and often painful swelling in the skin, gastrointestinal tract or airways. Although multiple therapies have been approved for the disease, we believe people living with HAE are in need of alternatives that better meet their objectives for quality of life and ease of disease control. Other than one oral therapy approved for prophylaxis, currently marketed therapies are all administered by injection, which patients find challenging despite their efficacy because they are painful, t