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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(Zip Code) |
(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 March 8, 2024, the registrant had
Table of Contents
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Page |
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Item 1. |
3 |
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3 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
4 |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity |
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7 |
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8 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
14 |
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Item 3. |
21 |
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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. |
23 |
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Item 5. |
23 |
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Item 6. |
24 |
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25 |
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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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January 31, |
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April 30, |
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2024 |
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2023 |
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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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Nine Months Ended |
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January 31, |
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January 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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Revenue |
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$ |
— |
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$ |
— |
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$ |
— |
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$ |
— |
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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 (loss) gain |
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( |
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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) loss on marketable securities included in net loss |
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( |
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( |
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( |
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Other comprehensive gain (loss) |
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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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Nine Months Ended January 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, 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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— |
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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, 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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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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( |
) |
||
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 January 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
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statement of Changes in Stockholders’ Equity
(in thousands, except share amounts)
(Unaudited)
|
Nine Months Ended January 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, 2022 |
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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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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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Reclassification adjustment for realized loss on marketable securities included in net loss |
|
— |
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— |
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— |
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— |
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Balance at July 31, 2022 |
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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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|||
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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— |
|
|
|
( |
) |
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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 loss 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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||
Balance at October 31, 2022 |
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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 common stock, net of issuance costs of $ |
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— |
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— |
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Issuance of pre-funded warrants for the purchase of common stock, net of issuance costs |
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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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|
( |
) |
Balance at January 31, 2023 |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
6
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
|
Nine Months Ended |
|
|||||
|
January 31, |
|
|||||
|
2024 |
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|
2023 |
|
||
Cash flows from operating activities |
|
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||
Net loss |
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
||
Stock-based compensation expense |
|
|
|
|
|
||
Realized (gain) loss from sale of marketable securities |
|
( |
) |
|
|
|
|
Non-cash operating lease expense |
|
( |
) |
|
|
|
|
Amortization of premium on marketable securities |
|
|
|
|
|
||
Foreign currency exchange loss (gain) |
|
|
|
|
( |
) |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
||
Research and development tax credit receivable |
|
( |
) |
|
|
|
|
Prepaid expenses and other assets |
|
|
|
|
|
||
Accounts payable |
|
( |
) |
|
|
( |
) |
Accrued expenses |
|
|
|
|
|
||
Net cash used in operating activities |
|
( |
) |
|
|
( |
) |
Cash flows from investing activities |
|
|
|
|
|
||
Purchases of marketable securities |
|
( |
) |
|
|
( |
) |
Sales and maturities of marketable securities |
|
|
|
|
|
||
Acquisition of property and equipment |
|
( |
) |
|
|
( |
) |
Website development costs |
|
( |
) |
|
|
- |
|
Net cash provided by investing activities |
|
|
|
|
|
||
Cash flows from financing activities |
|
|
|
|
|
||
Issuance of common stock from equity incentive plans |
|
|
|
|
|
||
Issuance of common stock, net of offering expenses of $ |
|
- |
|
|
|
|
|
Issuance of pre-funded warrants, net of offering expenses |
|
- |
|
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
||
Effect of exchange rate changes on cash and cash equivalents |
|
( |
) |
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
( |
) |
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
|
|
|
||
Cash and cash equivalents at end of period |
$ |
|
|
$ |
|
||
Supplemental disclosures of non-cash activities: |
|
|
|
|
|
||
Right of use assets obtained in exchange for operating lease liabilities |
$ |
- |
|
|
$ |
|
|
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. (“Company”) is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The Company applies its insights into the chemistry and biology of proteases to develop orally delivered, small molecule inhibitors with high selectivity, potency, and bioavailability that it believes will make them successful treatments for disease. The Company’s initial focus is on developing novel, oral therapeutics targeting hereditary angioedema (HAE).
In February 2024, the Company announced topline data from the Phase 3 KONFIDENT clinical trial evaluating the safety and efficacy of sebetralstat as the first potential oral, on-demand therapy for HAE. KONFIDENT was the largest and most representative trial ever conducted in HAE, enrolling a total of
The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile. Primary and key secondary endpoints were analyzed in a fixed, hierarchical sequence and adjusted for multiplicity. HAE attacks treated with both 300 mg and 600 mg of sebetralstat achieved the primary endpoint of beginning of symptom relief significantly faster than placebo (p<0.0001 for 300 mg, p=0.0013 for 600 mg). The median time to beginning of symptom relief was 1.6 hours with sebetralstat 300 mg, 1.8 hours with sebetralstat 600 mg and 6.7 hours with placebo. Key secondary endpoints showed that attacks treated with sebetralstat 300 mg or 600 mg achieved a significantly faster time to reduction in attack severity from baseline, compared to placebo (p=0.0036 for 300 mg and p=0.0032 for 600 mg). Attacks treated with sebetralstat 300 mg or 600 mg demonstrated a significantly faster time to complete attack resolution, compared to placebo (p=0.0022 for 300 mg and p<0.0001 for 600 mg). The KONFIDENT trial had no patient withdrawals due to an adverse event and no treatment-related serious adverse events (SAEs). Consistent with previous studies, sebetralstat was well-tolerated, with a safety profile similar to placebo.
The Company anticipates submitting a New Drug Application (“NDA”) for sebetralstat to the FDA in the first half of 2024. The Company also expects to file for approval in the European Union (“E.U.”) and Japan later in 2024.
In addition, the Company is conducting preclinical development of novel, oral Factor XIIa (“Factor XIIa”) inhibitors, which the Company initially is advancing to provide a next generation of HAE therapeutics. Factor XIIa also offers the opportunity for future expansion into other high unmet need indications in therapeutic areas outside HAE.
The Company’s headquarters is located in Cambridge, Massachusetts, with additional offices located in Porton Down, United Kingdom, Salt Lake City, Utah, and Zug, Switzerland.
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 candidates 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 a number of risks and uncertainties similar to those of other life science companies developing new products, including, among others, the risks related to the necessity to obtain adequate additional financing, to successfully develop product candidates, to obtain regulatory approval of product candidates, to comply with government regulations, to successfully commercialize its potential products, to the protection of proprietary technology and to the dependence on key individuals.
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 January 31, 2024, the Company had an accumulated deficit of $
8
On February 14, 2024, the Company 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
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.
The Company will need to expend substantial resources for research and development, including costs associated with the clinical testing of its product candidates and will need to obtain additional financing to fund its operations and to conduct trials for its product candidates. The Company will seek to finance future cash needs through equity offerings, future grants, corporate partnerships, and product sales.
The Company has never been profitable and has incurred significant operating losses in each year since its inception. Cash requirements may vary materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical advances, patent developments, regulatory changes, or other developments. Additional financing will be required to continue operations after the Company exhausts its current cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance that any such financing can be obtained by the Company, or if obtained, what the terms thereof may be, or that any amount that the Company is able to raise will be adequate to support the Company's working capital requirements until it achieves profitable operations. If adequate additional working capital is not secured when needed, the Company may be required to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible and/or suspend or curtail planned research programs. Any of these actions could materially harm the Company’s 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, 2024, 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, 2023 in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on July 10, 2023.
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.
Recent Accounting Pronouncements: In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which amends the impairment model by requiring entities to use a forward-looking approach on expected losses to estimate credit losses on certain financial instruments, including trade receivables and available-for-sale debt securities. This guidance became effective on May 1, 2023 and did not have a material impact to the consolidated financial statements. As the Company has never recorded any other-than-temporary-impairment adjustments to its available-for-sale debt securities prior to the effective date, no transition provisions were applicable to the Company.
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 the incremental common shares issuable upon the exercise of share options and awards.
9
Potential dilutive common share equivalents consist of:
|
|
January 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Stock options and awards |
|
|
|
|
|
|
||
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 January 31, 2024 and April 30, 2023 (in thousands):
|
|
|
|
|
|
|
|
|
|
Balance at |
|
||||
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
January 31, 2024 |
|
||||
Cash equivalents |
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
U.S. government agency securities |
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
Balance at |
|
||||
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
April 30, 2023 |
|
||||
Cash equivalents |
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
U.S. government agency securities |
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
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.
10
The following tables summarize the fair values of the Company’s investments by type as of January 31, 2024 and April 30, 2023 (in thousands):
|
January 31, 2024 |
|
|||||||||||||
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
||||
Corporate debt securities |
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Obligations of the U.S. Government and its agencies |
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Total |
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
April 30, 2023 |
|
|||||||||||||
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
||||
Corporate debt securities |
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Obligations of the U.S. Government and its agencies |
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
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 January 31, 2024, unrealized losses related to individual securities that had been in a continuous loss position for 12 months or longer were insignificant.
The following table summarizes the scheduled maturity for the Company’s marketable securities at January 31, 2024 (in thousands):
|
January 31, 2024 |
|
|
Maturing in one year or less |
$ |
|
|
Maturing after one year through two years |
|
|
|
Maturing after two years through three years |
|
|
|
Total |
$ |
|
|
4. Accrued Expenses
Accrued expenses consisted of the following as of January 31, 2024 and April 30, 2023 (in thousands):
|
|
January 31, |
|
|
April 30, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Accrued compensation |
|
$ |
|
|
$ |
|
||
Accrued research expense |
|
|
|
|
|
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
11
5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of January 31, 2024 and April 30, 2023 (in thousands):
|
|
January 31, |
|
|
April 30, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Prepaid preclinical and clinical activities |
|
$ |
|
|
$ |
|
||
Other prepaid expenses |
|
|
|
|
|
|
||
Interest and other receivables |
|
|
|
|
|
|
||
VAT receivable |
|
|
|
|
|
|
||
Total prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
||
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
The Company has lease agreements for approximately
The Company has a lease agreement in Salt Lake City, Utah for approximately
The Company has a lease agreement for approximately
The Company leases office space in Zug, Switzerland under an initial
Total rent expense was approximately $
12
The following table summarizes the maturity of undiscounted payments due under lease liabilities and the present value of those liabilities as of January 31, 2024 (in thousands):
Years ending April 30, |
|
Operating |
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Thereafter |
|
|
|
|
Total minimum lease payments |
|
|
|
|
Less amounts representing interest |
|
|
|
|
Present value of minimum payments |
|
|
|
|
Current portion |
|
|
|
|
Long-term portion |
|
$ |
|
|
Note 8. Subsequent Events
In February 2024, the achievement of the performance metric for certain performance-based restricted stock units (“PSUs”) granted in March 2022 and January 2024 with performance criteria based on positive data for the sebetralstat phase 3 KONFIDENT clinical trial were certified by the Compensation Committee of the Company’s Board of Directors (the "Board"). Consequently,
On February 14, 2024, the Company terminated its “at-the-market” program and sales agreement with Cantor Fitzgerald & Co., under which the Company could, from time to time, offer and sell shares of its common stock having an aggregate offering value of up to $
Also on February 14, 2024, the Company 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
On March 6, 2024, the Board appointed Benjamin L. Palleiko, the Company’s President, Chief Business Officer and Chief Financial Officer, as its Chief Executive Officer and principal executive officer. Mr. Palleiko will remain the Company’s principal financial officer. Mr. Palleiko was also appointed to the Board as a Class I director. Additionally, on March 6, 2024, T. Andrew Crockett announced his resignation from his position as the Chief Executive Officer and from his position on the Board, effective immediately. Mr. Crockett’s resignation is not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
13
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, global macroeconomic conditions, 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 small molecule protease inhibitors for diseases with significant unmet need. We apply our insights into the chemistry and biology of proteases to develop orally delivered therapeutics with high selectivity, potency, and bioavailability that we believe will make them successful treatments for diseases. We have used these capabilities to develop a novel, small molecule plasma kallikrein inhibitor targeting the disease hereditary angioedema (“HAE”). We also are conducting preclinical development on a novel, oral Factor XIIa (“Factor XIIa”) inhibitor program, which we are initially advancing to provide a next generation of HAE therapeutics, and which also offers the opportunity for expansion into other high unmet need indications in the future.
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 can find challenging despite their efficacy because they can be painful, time consuming to deliver and difficult to store. As a result, many attacks are treated too late to prevent significant symptoms, and a large percentage are not treated at all, which can lead to needless suffering. We anticipate that there will be strong interest in safe and effective, orally delivered, small molecule treatments, and our strategy is to develop oral drug candidates for both on-demand and prophylactic use with the goal of providing patients with a complete set of oral options to treat their disease.
In February 2024, we announced topline data from the Phase 3 KONFIDENT clinical trial to evaluate the safety and efficacy of sebetralstat as the first potential oral, on-demand therapy for HAE. KONFIDENT was the largest and most representative trial ever conducted in HAE, enrolling a total of 136 patients from 66 clinical sites across 20 countries. Eligible participants included adolescents, patients using long-term prophylaxis, and the trial evaluated all attack severities and locations.
The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile. Primary and key secondary endpoints were analyzed in a fixed, hierarchical sequence and adjusted for multiplicity. HAE attacks treated with both 300 mg and 600 mg of sebetralstat achieved the primary endpoint of beginning of symptom relief significantly faster than placebo (p<0.0001 for 300 mg, p=0.0013 for 600 mg). The median time to beginning of symptom relief was 1.61 hours with sebetralstat 300 mg, 1.79 hours with sebetralstat 600 mg and 6.72 hours with placebo. Both key secondary endpoints were met; attacks treated with sebetralstat 300 mg or 600 mg achieving a significantly faster time to a reduction in attack severity from baseline (p=0.0036 for 300 mg and p=0.0032 for 600 mg) and a significantly faster time to complete attack resolution (p=0.0022 for 300 mg and p<0.0001 for 600 mg) compared to placebo. The KONFIDENT trial had no patient withdrawals due to an adverse event and no treatment-related serious adverse events (SAEs). Consistent with previous studies, sebetralstat was well-tolerated, with a safety profile similar to placebo.
14
We anticipate submitting a New Drug Application (“NDA”) for sebetralstat to the FDA in the first half of 2024. We also expect to file for approval in the European Union (“E.U.”) and Japan later in 2024.
In addition, we are conducting preclinical development of novel, oral Factor XIIa (“Factor XIIa”) inhibitors, which we are initially advancing to provide a next generation of HAE therapeutics. Factor XIIa also offers the opportunity for future expansion into other high unmet need indications in therapeutic areas outside HAE.
In August 2022, we initiated KONFIDENT-S, a two-year open-label extension trial assessing the long-term safety and tolerability of sebetralstat. In addition, this study is examining the potential use of sebetralstat as short-term prophylaxis in the setting of medical and dental procedures, where HAE attacks are known to be triggered. KONFIDENT-S continues to enroll patients, and we expect to provide a robust safety database to support the planned NDA filing. In total, more than 800 attacks have been treated across KONFIDENT and KONFIDENT-S to date, and KONFIDENT-S includes numerous patients who have taken multiple doses for treatment. We also are developing an oral disintegrating tablet (“ODT”) formulation of sebetralstat and have received FDA feedback on our proposed development program to support a supplemental NDA submission, which did not include a requirement to conduct efficacy trials. We anticipate that the ODT formulation will follow the expected initial launch formulation in the U.S. and E.U. and may become the initial launch formulation in other geographies.
Sebetralstat has received Fast Track and Orphan Drug designations from the FDA, as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the European Medicines Agency (EMA). In November 2023, sebetralstat was granted Orphan Drug Status in Switzerland. In February 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) awarded the Innovation Passport for sebetralstat.
Our oral Factor XIIa inhibitor program targets an enzyme that plays a key role in HAE, as the most upstream mechanism in the biochemical pathway that initiates HAE attacks. For this reason, we believe that inhibition of Factor XIIa will block the underlying mediators of HAE attacks, including the uncontrolled generation of both plasma kallikrein and bradykinin which lead to swelling and pain. Clinical studies of an injectable Factor XIIa-inhibitory antibody have demonstrated a high degree of efficacy in preventing HAE attacks, and there are no known safety implications of long-term inhibition of this enzyme. We believe that our program has the potential to be the first orally delivered Factor XIIa inhibitor to enter clinical development, initially for HAE and over time for additional indications that are supported by scientific evidence. We continue to progress multiple compounds through the discovery phase. Concurrently, we have presented preclinical data supporting potential development in HAE as well as thrombosis and inflammation.
On December 23, 2022, we entered into subscription agreements with institutional investors to sell, in a registered direct offering, an aggregate of 9,484,199 shares of our common stock at a price of $6.00 per share and pre-funded warrants to purchase up to 182,470 shares of common stock at a price of $5.999 per pre-funded warrant. The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, less the $0.001 per share exercise price of each pre-funded warrant. The net proceeds from the registered direct offering, after deducting estimated expenses, were approximately $57.7 million.
On February 14, 2024, we terminated our “at-the-market” program and sales agreement with Cantor Fitzgerald & Co., under which we could, from time to time, offer and sell shares of our common stock having an aggregate offering value of up to $100.0 million. Prior to delivering the written notice, no shares of our common stock were offered or sold pursuant to this “at-the-market” offering with Cantor Fitzgerald & Co.
On February 14 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 price of $15.25 per share and pre-funded warrants to purchase up to 3,483,688 shares of common stock at a price of $15.249 per pre-funded warrant (the "Underwritten Offering"). The net proceeds from the Underwritten Offering, after deducting estimated expenses, were approximately $150.1 million.
We have devoted substantially all our efforts to research and development, including clinical trials of our product candidates. We have not completed the development of any product candidates. Pharmaceutical drug product candidates, like those being developed by us, require approvals from the FDA or foreign regulatory agencies prior to commercial sales. There can be no assurance that any product candidates will receive the necessary approvals and any failure to receive approval or delay in approval may have a material adverse impact on our business and financial results. We are subject to a number of risks and uncertainties similar to those of other life science companies developing new products, including, among others, the risks related to the necessity to obtain adequate additional financing, to successfully develop product candidates, to obtain regulatory approval of product candidates, to comply with government regulations, to successfully commercialize our potential products, to the protection of proprietary technology and to our dependence on key individuals.
15
Financial Overview
Revenue
We have not generated any revenue in the current fiscal year. To date, we have not generated any revenues from the sale of products, and we do not have any products that have been approved for commercialization. We do not expect to generate product revenue unless and until we obtain regulatory approval for, and commercialize, one of our current or future product candidates.
Research and Development Expenses
Research and development expenses primarily consist of costs associated with our research activities, including the preclinical and clinical development of product candidates. We contract with clinical research organizations to manage our clinical trials under agreed upon budgets for each study, with oversight by our clinical program managers. All research and development costs are expensed as incurred.
Costs for certain research and development activities, such as manufacturing development activities and clinical studies are recognized based on the contracted amounts, as adjusted for the percentage of work completed to date. Payments for these activities are based on the terms of the contractual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as prepaid or accrued expenses. We defer and capitalize non-refundable advance payments made for research and development activities until the related goods are delivered or the related services are performed.
We expect to continue to incur substantial expenses related to development activities for the foreseeable future as we conduct clinical development, manufacturing, and toxicology studies. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, additional drug manufacturing requirements, and later stage toxicology studies such as carcinogenicity studies. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. The probability of success for each product candidate is affected by numerous factors, including preclinical data, clinical data, competition, manufacturing capability and commercial viability. Accordingly, we may never succeed in achieving marketing approval for any of our product candidates.
Completion dates and costs for clinical development programs as well as our research program can vary significantly for each current and future product candidate and are difficult to predict. As a result, we cannot currently estimate with any degree of certainty the costs associated with development of our product candidates. We anticipate making determinations as to which programs and product candidates to pursue and how much funding to direct to each program and product candidate on an ongoing basis in response to the scientific success of early research programs, results of ongoing and future clinical trials, our ability to enter into collaborative agreements with respect to programs or potential product candidates, as well as ongoing assessments as to the commercial potential of each current or future product candidate.
General and Administrative Expenses
General and administrative expenses consist primarily of the costs associated with general management, obtaining and maintaining our patent portfolio, commercial planning, professional fees for accounting, auditing, consulting and legal services, and general overhead expenses.
We expect ongoing general and administrative expenses to increase in the future as we expand our operating activities, including commercial planning, maintaining and expanding the patent portfolio and incurring additional costs associated with the management of a public company such as maintaining compliance with exchange listing and SEC requirements. These potential increases will likely include management costs, legal fees, accounting fees, directors’ and officers’ liability insurance premiums, and expenses associated with investor relations, among others.
Other Income
Other income consists of interest income earned on bank interest and marketable securities, research and development tax credits from the United Kingdom government’s tax incentive programs set up to encourage research and development in the United Kingdom, realized gains and losses from marketable securities and realized and unrealized exchange rate gains and losses on cash held in foreign currencies and transactions settled in foreign currencies.
16
Income Taxes
We historically have incurred net losses and had no corporation tax liabilities. We file U.S. Federal tax returns, as well as certain state returns. We also file returns in the United Kingdom. Under the U.K. government’s research and development tax incentive scheme, we have incurred qualifying research and development expenses and filed claims for research and development tax credits in accordance with the relevant tax legislation. The research and development tax credits are paid out to us in cash and reported as other income. Because of the operating losses and the full valuation allowance provided on all deferred tax assets, including the net operating loss carry forward, no income tax provision has been recognized in the three and nine months ended January 31, 2024.
For tax purposes, pursuant to the Tax Cuts and Jobs Act of 2017, the Company is required to capitalize and subsequently amortize all R&D expenditures over five years for research activities conducted in the U.S. and over fifteen years for research activities conducted outside of the U.S. The Company adopted ASU 2019-12 as of January 1, 2022.
Results of Operations
Comparison of the three months ended January 31, 2024 and 2023
The following table sets forth the key components of our results of operations for the three months ended January 31, 2024 and 2023 (in thousands):
|
|
Three Months Ended |
|
|
|
|
|
||||||
|
|
January 31, |
|
|
Increase |
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
(decrease) |
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|||
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|||
Research and development expenses |
|
|
22,523 |
|
|
|
20,063 |
|
|
|
2,460 |
|
|
General and administrative expenses |
|
|
10,628 |
|
|
|
6,882 |
|
|
|
3,746 |
|
|
Other income |
|
|
|
|
|
|
|
|
|
|
|||
Interest, exchange rate gain and other income |
|
|
4,123 |
|
|
|
5,642 |
|
|
|
(1,519 |
) |
|
Revenue. No revenue was recognized in the quarters ended January 31, 2024 or 2023.
Research and Development Expenses. Research and development expenses increased $2.5 million due to increases in spending on personnel costs of $0.7 million and sebetralstat spending of $3.0 million, offset by decreases in spending on KVD824 of $1.8 million and preclinical and other activities of $0.5 million compared to the same period in the prior fiscal year. The impact of exchange rates on research and development expenses resulted in an increase to expenses of $0.7 million in the three months ended January 31, 2024 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 |
|
|
|
|
||||||
|
|
January 31, |
|
|
Increase |
|
||||||
|
|
2024 |
|
|
2023 |
|
|
(decrease) |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Program-specific costs |
|
|
|
|
|
|
|
|||||
Sebetralstat |
|
$ |
10,836 |
|
|
$ |
7,792 |
|
|
$ |
3,044 |
|
KVD824 |
|
|
29 |
|
|
|
1,802 |
|
|
|
(1,773 |
) |
Unallocated costs |
|
|
|
|
|
|
|
|
|
|||
Personnel |
|
|
6,794 |
|
|
|
6,116 |
|
|
|
678 |
|
Preclinical and other activities |
|
|
4,864 |
|
|
|
4,353 |
|
|
|
511 |
|
Total |
|
$ |
22,523 |
|
|
$ |
20,063 |
|
|
$ |
2,460 |
|
Expenses for the sebetralstat program increased primarily due to the Phase 3 KONFIDENT and KONFIDENT-S trials. We anticipate that these expenses will remain at or slightly below current levels due to the completion of the Phase 3 KONFIDENT trial in
17
February 2024, while the KONFIDENT-S trial continues to enroll participants and we initiate other clinical studies to support the expansion of the sebetralstat commercial opportunity.
Expenses for KVD824 decreased due to the termination of the Phase 2 KOMPLETE clinical trial in October 2022. We anticipate that these expenses will cease in the near term as we do not anticipate any further development of KVD824.
Personnel expenses increased primarily due to higher research and development and medical headcount compared to the same period in the prior year. We anticipate that these expenses will continue to increase for the medical team as we support ongoing development activities and prepare for the planned eventual commercialization of sebetralstat.
Expenses for preclinical and other activities increased primarily due to spending in support of HAE awareness within the medical community. We anticipate that these expenses will continue at or above current levels as we continue development on the oral Factor XIIa inhibitor program and other preclinical activities.
General and Administrative Expenses. General and administrative expenses increased by $3.7 million primarily due to increases in employee related expenses of $2.5 million, commercial planning expenses of $1.1 million, and travel expenses of $0.1 million. We anticipate that expenses will continue at or above current levels as we continue to expand to support the growth of the Company and the planned commercialization of sebetralstat.
Other Income. Other income decreased $1.5 million primarily due to a decrease of $2.2 million in income from research and development tax credits, offset by an increase in foreign currency exchange rate gains of $0.5 million from transactions denominated in foreign currencies in our U.K. subsidiary, and an increase in realized gain from marketable securities of $0.2 million. The decrease in income from research and development credits was driven by the U.K. government's changes to the research and development tax credit program which reduced the payable tax credit of approximately 33.4% of eligible research and development expenditures to 18.6% after April 1, 2023. Additionally, the cash rebate for subcontracted research expenditures are eligible for decreased from approximately 21.7% to 12.1% after April 1, 2023.
Comparison of the nine months ended January 31, 2024 and 2023
The following table sets forth the key components of our results of operations for the nine months ended January 31, 2024 and 2023 (in thousands):
|
|
Nine Months Ended |
|
|
|
|
||||||
|
|
January 31, |
|
|
Increase |
|
||||||
|
|
2024 |
|
|
2023 |
|
|
(decrease) |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|||
Research and development expenses |
|
|
60,919 |
|
|
|
56,325 |
|
|
|
4,594 |
|
General and administrative expenses |
|
|
31,071 |
|
|
|
22,818 |
|
|
|
8,253 |
|
Other income |
|
|
|
|
|
|
|
|
|
|||
Interest, exchange rate gain and other income |
|
|
9,995 |
|
|
|
12,541 |
|
|
|
(2,546 |
) |
Revenue. No revenue was recognized in the six months ended January 31, 2024 or 2023.
Research and Development Expenses. Research and development expenses increased $4.6 million due to an increase in spending on sebetralstat of $9.7 million and an increase in personnel costs of $2.2 million, offset by decreases in spending on KVD824 of $6.3 million and preclinical activities of $1.1 million as compared to the same period in the prior fiscal year. The impact of exchange rates on research and development expenses resulted in an increase to expenses of $2.1 million in the nine months ended January 31, 2024 compared to the same period in the prior fiscal year, which is reflected in the figures above.
18
Research and development expenses by major programs or categories were as follows (in thousands):
|
|
Nine Months Ended |
|
|
|
|
||||||
|
|
January 31, |
|
|
Increase |
|
||||||
|
|
2024 |
|
|
2023 |
|
|
(decrease) |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Program-specific costs |
|
|
|
|
|
|
|
|
|
|||
Sebetralstat |
|
$ |
27,782 |
|
|
$ |
18,094 |
|
|
$ |
9,688 |
|
KVD824 |
|
|
755 |
|
|
|
7,031 |
|
|
|
(6,276 |
) |
Unallocated costs |
|
|
|
|
|
|
|
|
|
|||
Personnel |
|
|
19,978 |
|
|
|
17,746 |
|
|
|
2,232 |
|
Preclinical activities |
|
|
12,404 |
|
|
|
13,454 |
|
|
|
(1,050 |
) |
Total |
|
$ |
60,919 |
|
|
$ |
56,325 |
|
|
$ |
4,594 |
|
Expenses for the sebetralstat program increased primarily due to the Phase 3 KONFIDENT and KONFIDENT-S trials. We anticipate that these expenses will remain at or slightly below current levels due to the completion of the Phase 3 KONFIDENT trial in February 2024, while KONFIDENT-S continues to enroll participants and we initiate other clinical studies to support the expansion of the sebetralstat commercial opportunity
Expenses for KVD824 decreased due to the termination of the Phase 2 KOMPLETE clinical trial in October 2022. We anticipate that these expenses will cease in the near term as we do not anticipate any further development of KVD824.
Personnel expenses increased primarily due to higher research and development and medical headcount compared to the same period in the prior year. We anticipate that these expenses will continue to increase for the medical team as we support ongoing development activities and prepare for the planned eventual commercialization of sebetralstat.
Expenses for preclinical and other activities decreased primarily due to decreased manufacturing costs compared to the same period in the prior year. We anticipate that these expenses will continue at or above current levels as we continue development on the oral Factor XIIa inhibitor program and other preclinical activities.
General and Administrative Expenses. General and administrative expenses increased $8.3 million primarily due to increases in employee related expenses of $5.9 million, commercial planning expenses of $1.8 million, professional fees of $0.3 million, supply chain expenses of $0.1 million, and travel expenses of $0.2 million. We anticipate that expenses will continue at or above current levels as we continue to expand to support the growth of the Company and the planned commercialization of sebetralstat.
Other Income. Other income decreased $2.5 million primarily due to a decrease of $5.2 million in income from research and development tax credits as a result of the tax credit rate change in April 2023. This decrease was offset by increases to realized gains from available for sale securities of $1.2 million, an increase to interest income of $1.0 million, and an increase in foreign currency exchange rate gains of $0.5 million from transactions denominated in foreign currencies in our U.K. subsidiary.
Liquidity and Capital Resources
Since inception, we have not generated any revenue from product sales and have incurred losses since inception and cash outflows from operating activities for the nine months ended January 31, 2024 and 2023. We have funded operations primarily through the issuance of capital stock and pre-funded warrants. 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.
In December 2022, we entered into subscription agreements with institutional investors to sell, in a registered direct offering, an aggregate of 9,484,199 shares of our common stock at a price of $6.00 per share and pre-funded warrants to purchase up to 182,470 shares of common stock at a price of $5.999 per pre-funded warrant. The net proceeds from the registered direct offering, after deducting estimated expenses, were approximately $57.7 million.
19
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 price of $15.25 per share and pre-funded warrants to purchase up to 3,483,688 shares of common stock at a price of $15.249 per pre-funded warrant. The net proceeds from the Underwritten Offering, after deducting estimated expenses, were approximately $150.1 million.
Cash Flows
The following table shows a summary of the net cash flow activity for the nine months ended January 31, 2024 and 2023 (in thousands):
|
|
Nine Months Ended |
|
|||||
|
|
January 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
|
|
|
|
|||||
Cash flows used in operating activities |
|
$ |
(74,126 |
) |
|
$ |
(52,625 |
) |
Cash flows provided by investing activities |
|
|
41,467 |
|
|
|
47,625 |
|
Cash flows provided by financing activities |
|
|
616 |
|
|
|
58,149 |
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(1,139 |
) |
|
|
1,168 |
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
(33,182 |
) |
|
$ |
54,317 |
|
Net cash used in operating activities
Net cash used in operating activities was $74.1 million for the nine months ended January 31, 2024 and primarily consisted of a net loss of $82.0 million adjusted for stock-based compensation of $9.2 million, an increase in the research and development tax credit receivable of $6.2 million, realized gains from available for sale securities of $1.1 million, a decrease in prepaid expenses and other assets of $0.9 million and other changes in net working capital. The research and development tax credit receivable increased due to the accrual of tax credits in the nine months ended January 31, 2024. Net cash used in operating activities was $52.6 million for the nine months ended January 31, 2023 and primarily consisted of a net loss of $66.6 million adjusted for stock-based compensation of $7.5 million, a decrease in the research and development tax credit receivable of $2.1 million, a decrease in prepaid expenses and other assets of $4.4 million, and other changes in net working capital.
Net cash provided by investing activities
Net cash provided by investing activities for the nine months ended January 31, 2024 was $41.5 million and primarily consisted of the sales and maturities of marketable securities of $89.5 million offset by purchases of marketable securities of $47.7 million, as compared to $47.6 million provided by investing activities during the same period in the prior year primarily due to the sales and maturities of marketable securities of $112.5 million offset by purchases of marketable securities of $63.8 million.
Net cash provided by financing activities
Net cash provided by financing activities during the nine months ended January 31, 2024 was $0.6 million and consisted of the issuance of common stock from equity incentive plans, compared to $58.2 million in the same period in the prior year which primarily consisted of $57.7 million in net proceeds from the December 2022 registered direct offering of common stock and pre-funded warrants.
Operating Capital Requirements
To date, we have not generated any revenues from the sale of products, and we do not have any products that have been approved for commercialization. We do not expect to generate product revenue unless and until we obtain regulatory approval for, and commercialize, one of our current or future product candidates. We anticipate that we will continue to incur losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, product candidates, and begin to commercialize any approved products. We are subject to all of the risks inherent in the development of new therapeutic products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We currently anticipate that, based upon our operating plans and existing capital resources, we have sufficient funding to operate for at least the next twelve months. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our preclinical and clinical development efforts, future growth to support commercial sales of any approved products, and other activities we may choose to undertake.
20
Until such time, if ever, as we can generate substantial revenues, we expect to finance our cash needs through a combination of equity and debt financings, collaborations, strategic partnerships, and licensing arrangements. To the extent that additional capital is raised through the sale of stock or convertible debt securities, the ownership interest of existing stockholders will be diluted, and the terms of these newly issued securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing, if available, may involve agreements that include increased fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, selling or licensing intellectual property rights and other operating restrictions that could adversely impact our ability to conduct business. Additional fundraising through collaborations, strategic partnerships or licensing arrangements with third parties may require us to relinquish valuable rights to product candidates, including our other technologies, future revenue streams or research programs, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate product development or future commercialization efforts or grant rights to develop and commercialize other product candidates even if we would otherwise prefer to develop and commercialize such product candidates internally.
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, 2023, filed with the SEC on July 10, 2023. We are party to several operating leases for office and laboratory space as of January 31, 2024.
Critical Accounting Policies and Significant Judgments and 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 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, 2023, filed with the SEC on July 10, 2023.
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.
21
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 January 31, 2024. 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 January 31, 2024.
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 January 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
22
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, 2023.
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, 2023 filed with the SEC on July 10, 2023, 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 third quarter of fiscal 2024, the following trading plans were adopted or terminated:
Name |
Title |
Action |
Date |
Intended to satisfy the affirmative defense of Rule 10b5-1? |
Expiration Date |
Total Amount of Common Stock to be Sold Under the Plan |
Yes(1) |
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Item 6. EXHIBITS
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Incorporated by Reference |
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Exhibit Number |
Exhibit Description |
Form |
File No. |
Exhibit |
Filing Date |
Filed Herewith |
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4.1 |
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X |
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31.1 |
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X |
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32.1# |
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X |
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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. |
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101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
Inline XBRL Taxonomy Extension Labels Linkbase Document |
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101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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# 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.
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SIGNATURE
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.
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KALVISTA PHARMACEUTICALS, INC.
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Date: March 11, 2024 |
By: |
/s/ Benjamin L. Palleiko |
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Benjamin L. Palleiko Chief Executive Officer (Principal Executive, Financial and Accounting Officer) |
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