Exhibit 99.1
KalVista Pharmaceuticals Reports Third Fiscal Quarter Results
– KVD900 Phase 3 KONFIDENT Trial Initiated–
– KVD824 Phase 2 KOMPLETE Clinical Trial Enrollment on Track –
Cambridge, MA and Salisbury, England, March 10, 2022 – KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2022.
“We made many significant clinical advances this quarter,” said Andrew Crockett, Chief Executive Officer of KalVista. “We are excited that the KVD900 Phase 3 KONFIDENT trial for on-demand treatment of HAE attacks is now underway, and we are encouraged by the progress of our KVD824 Phase 2 KOMPLETE trial for HAE prophylaxis. Based on initial enrollment trends, we expect we will be able to provide data for both studies in 2023.”
Third Fiscal Quarter and Recent Business Highlights:
Third Fiscal Quarter Financial Results:
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista is developing KVD900 as an oral on-demand therapy for acute HAE attacks and has initiated the Phase 3 KONFIDENT clinical trial. KVD824 is in development for prophylactic treatment of HAE, with the Phase 2 KOMPLETE clinical trial underway. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of HAE for patients. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.
For more information about KalVista, please visit www.kalvista.com.
For more information on the KVD900 HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.
For more information on the KVD824 HAE prophylaxis Phase 2 KOMPLETE study, please visit www.kompletestudy.com.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe,"
"project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties, including the potential impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our Phase 3 KONFIDENT and Phase 2 KOMPLETE clinical trials, and to obtain regulatory approvals for KVD900, KVD824 and other candidates in development, the ability of KVD900, KVD824 and other candidates in development to treat HAE or DME, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2021, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact:
KalVista Pharmaceuticals, Inc.
Ben Palleiko
CBO & CFO
857-999-0890
investors@kalvista.com
KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Balance Sheets |
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(in thousands, except share and per share amounts) |
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(Unaudited) |
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| January 31, |
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| April 30, |
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| 2022 |
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| 2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents | $ | 45,577 |
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| $ | 50,592 |
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Marketable securities |
| 149,212 |
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| 198,337 |
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Research and development tax credit receivable |
| 11,287 |
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| 10,418 |
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Prepaid expenses and other current assets |
| 8,388 |
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| 4,917 |
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Total current assets |
| 214,464 |
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| 264,264 |
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Property and equipment, net |
| 2,215 |
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| 1,791 |
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Right of use assets |
| 8,180 |
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| 5,758 |
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Other assets |
| 193 |
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| 200 |
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Total assets | $ | 225,052 |
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| $ | 272,013 |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable | $ | 2,185 |
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| $ | 1,981 |
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Accrued expenses |
| 6,450 |
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| 6,930 |
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Lease liability - current portion |
| 1,014 |
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| 863 |
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Total current liabilities |
| 9,649 |
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| 9,774 |
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Long-term liabilities: |
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Lease liability - net of current portion |
| 7,467 |
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| 5,046 |
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Total long-term liabilities |
| 7,467 |
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| 5,046 |
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Stockholders’ equity: |
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Common stock, $0.001 par value |
| 24 |
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| 24 |
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Additional paid-in capital |
| 436,313 |
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| 426,437 |
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Accumulated deficit |
| (226,062 | ) |
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| (167,836 | ) |
Accumulated other comprehensive loss |
| (2,339 | ) |
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| (1,432 | ) |
Total stockholders’ equity |
| 207,936 |
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| 257,193 |
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Total liabilities and stockholders' equity | $ | 225,052 |
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| $ | 272,013 |
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KalVista Pharmaceuticals Inc. | |||||||
Condensed Consolidated Statement of Operations | |||||||
(in thousands, except share and per share amounts) | |||||||
(Unaudited) | |||||||
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| Three Months Ended |
| Nine Months Ended | ||||
| January 31, |
| January 31, | ||||
| 2022 |
| 2021 |
| 2022 |
| 2021 |
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Revenue | $— |
| $— |
| $— |
| $— |
Operating expenses: |
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Research and development | 19,738 |
| 9,097 |
| 50,954 |
| 29,409 |
General and administrative | 6,945 |
| 3,560 |
| 18,848 |
| 10,472 |
Total operating expenses | 26,683 |
| 12,657 |
| 69,802 |
| 39,881 |
Operating loss | (26,683) |
| (12,657) |
| (69,802) |
| (39,881) |
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Other income: |
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Interest income | 258 |
| 137 |
| 822 |
| 589 |
Foreign currency exchange (loss) gain | (198) |
| 301 |
| (529) |
| 715 |
Other income | 4,156 |
| 2,171 |
| 11,283 |
| 7,289 |
Total other income | 4,216 |
| 2,609 |
| 11,576 |
| 8,593 |
Net loss | $(22,467) |
| $(10,048) |
| $(58,226) |
| $(31,288) |
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Net loss per share, basic and diluted | $(0.92) |
| $(0.56) |
| $(2.38) |
| $(1.75) |
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Weighted average common shares outstanding, basic and diluted | 24,479,660 |
| 17,961,802 |
| 24,449,788 |
| 17,905,926 |
KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Statements of Cash Flows |
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(in thousands, unaudited) |
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| Nine Months Ended |
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| January 31, |
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| 2022 |
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| 2021 |
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Cash flows from operating activities |
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Net loss | $ | (58,226 | ) |
| $ | (31,288 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
| 408 |
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| 397 |
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Stock-based compensation expense |
| 8,432 |
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| 3,677 |
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Realized loss (gain) from sale of marketable securities |
| 296 |
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| (192 | ) |
Non-cash operating lease expense |
| 153 |
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| 25 |
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Amortization of premium on marketable securities |
| 2,081 |
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| 247 |
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Foreign currency exchange loss (gain) |
| 698 |
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| (441 | ) |
Changes in operating assets and liabilities: |
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Research and development tax credit receivable |
| (1,477 | ) |
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| 10,135 |
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Prepaid expenses and other current assets |
| (3,659 | ) |
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| 35 |
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Accounts payable |
| 228 |
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| (1,182 | ) |
Accrued expenses |
| (279 | ) |
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| (539 | ) |
Net cash used in operating activities |
| (51,345 | ) |
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| (19,126 | ) |
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Cash flows from investing activities |
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Purchases of marketable securities |
| (84,415 | ) |
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| (26,814 | ) |
Sales and maturities of marketable securities |
| 130,686 |
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| 45,692 |
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Acquisition of property and equipment |
| (845 | ) |
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| (49 | ) |
Net cash provided by investing activities |
| 45,426 |
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| 18,829 |
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Cash flows from financing activities |
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Issuance of common stock , net of offering expenses |
| - |
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| 1,648 |
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Issuance of common stock from equity incentive plans |
| 1,443 |
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| 161 |
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Net cash provided by financing activities |
| 1,443 |
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| 1,809 |
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Effect of exchange rate changes on cash and cash equivalents |
| (539 | ) |
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| 426 |
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Net (decrease) increase in cash and cash equivalents |
| (5,015 | ) |
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| 1,938 |
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Cash and cash equivalents at beginning of period |
| 50,592 |
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| 15,789 |
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Cash and cash equivalents at end of period | $ | 45,577 |
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| $ | 17,727 |
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