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KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results - FDA End-of-Phase 2 Meeting on KVD900 Oral HAE Phase 3 Program Scheduled for Late Q3 2021 - - FDA Response Submission for KVD824 Pha

Key Takeaway: KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results - FDA End-of-Phase 2 Meeting on KVD900 Oral HAE Phase 3 Program Scheduled for Late Q3 2021 - - FDA Response Submission for KVD824 Phase 2 Clinical Hold Expected Q3 2021 - Cambridge, MA and S

Full Press Release Details

KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
- FDA End-of-Phase 2 Meeting on KVD900 Oral HAE Phase 3 Program Scheduled for Late Q3 2021 -
- FDA Response Submission for KVD824 Phase 2 Clinical Hold Expected Q3 2021 -
Cambridge, MA and Salisbury, England, July 13, 2021 - KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal year ended April 30, 2021.
"This past fiscal year we made great strides in providing data to support the development of the candidates in our oral hereditary angioedema franchise," said Andrew Crockett, Chief Executive Officer of KalVista. "Now we are at an important inflection point as we work with regulatory agencies to both finalize the Phase 3 program for KVD900 and begin the Phase 2 clinical trial of KVD824. With our financing earlier this year we are well-capitalized to focus on execution of these activities, and we look forward to providing additional details on the trials later this year as they begin."
Fiscal 2021 and Recent Business Highlights:
Fourth Quarter and Full Year Financial Results:
On July 11, 2021, the Board of Directors adopted the KalVista Pharmaceuticals, Inc. 2021 Inducement Equity Incentive Plan (the "Plan"). The Plan reserves 350,000 shares of common stock to be used exclusively for grants of awards to individuals that were not previously employees or directors of KalVista, as an inducement material to the individual's entry into employment with KalVista within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The Plan was approved by Board of Directors without stockholder approval pursuant to Rule 5635(c)(4), and the terms and conditions of the Plan are substantially similar to KalVista's stockholder-approved 2017 Equity Incentive Plan, as amended.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of 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, which completed a Phase 2 efficacy trial in February 2021, demonstrating statistical and clinical significance across all endpoints. KVD824 is in development for prophylactic treatment of HAE. 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, please visit www.kalvista.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, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence or complete clinical studies and to obtain regulatory approvals for KVD900, KVD824 and other candidates in development, our ability to resolve a clinical hold with regards to KVD824, the ability of KVD900, KVD824 and other candidates in development to treat HAE or DME, the future progress and potential success of our oral Factor XIIa program, and the sufficiency of our cash, cash equivalents and investments to fund our operations. Further information on potential risk factors that could affect our business and financial results are detailed in our annual report on Form 10-K filed on July 1, 2020, our quarterly reports on Form 10-Q, and other filings 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.
KalVista Pharmaceuticals, Inc.
Senior Director, Corporate Communications & Investor Relations
KalVista Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
April 30, April 30,
2021 2020
Assets
Current assets:
Cash and cash equivalents $ 50,592 $ 15,789
Marketable securities 198,337 51,925
Research and development tax credit receivable 10,418 16,527
Prepaid expenses and other current assets 4,917 4,455
Total current assets 264,264 88,696
Property and equipment, net 1,791 2,043
Right of use assets 5,758 1,612
Other assets 200 178
Total assets $ 272,013 $ 92,529
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 1,981 $ 1,677
Accrued expenses 6,930 5,455
Lease liability - current portion 863 588
Total current liabilities 9,774 7,720
Long-term liabilities:
Lease liability - net of current portion 5,046 1,057
Total long-term liabilities 5,046 1,057
Stockholders' equity:
Common stock, $0.001 par value 24 18
Additional paid-in capital 426,437 207,208
Accumulated deficit (167,836 ) (121,592 )
Accumulated other comprehensive loss (1,432 ) (1,882 )
Total stockholders' equity 257,193 83,752
Total liabilities and stockholders' equity $ 272,013 $ 92,529
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended Years Ended
April 30, April 30,
2021 2020 2021 2020
Revenue $ - $ 3,824 $ - $ 12,690
Operating expenses:
Research and development 11,877 9,485 41,286 40,194
General and administrative 6,165 3,296 16,637 13,029
Total operating expenses 18,042 12,781 57,923 53,223
Operating loss (18,042 ) (8,957 ) (57,923 ) (40,533 )
Other income:
Interest income 314 363 903 1,830
Foreign currency exchange rate gain (loss) 132 (613 ) 847 (367 )
Other income 2,639 2,498 9,929 9,830
Total other income 3,085 2,248 11,679 11,293
Loss before income taxes (14,957 ) (6,709 ) (46,244 ) (29,240 )
Income tax (benefit) expense - (124 ) - (124 )
Net loss $ (14,957 ) $ (6,585 ) $ (46,244 ) $ (29,116 )
Net loss per share, basic and diluted $ (0.65 ) $ (0.37 ) $ (2.42 ) $ (1.64 )
Weighted average common shares outstanding, basic and diluted 23,118,127 17,845,599 19,094,440 17,748,666
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
Years Ended
April 30,
2021 2020
Cash flows from operating activities
Net loss $ (46,244 ) $ (29,116 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 537 512
Stock-based compensation expense 7,118 4,448
Realized (gain) from sale of marketable securities (153 ) (300 )
Non-cash operating lease expense 114 13
Amortization of premium on available for sale securities 685 193
Foreign currency exchange (gain) loss (574 ) 74
Changes in operating assets and liabilities:
Research and development tax credit receivable 7,457 (5,781 )
Prepaid expenses and other current assets (222 ) (1,112 )
Other assets (22 ) (5 )
Accounts payable 150 (1,004 )
Accrued expenses 983 (48 )
Deferred revenue - (12,690 )
Net cash used in operating activities (30,171 ) (44,816 )
Cash flows from investing activities
Purchases of available for sale securities (201,210 ) (49,797 )
Sales and maturities of available for sale securities 53,638 66,770
Acquisition of property and equipment (82 ) (220 )
Net cash provided by (used in) investing activities (147,654 ) 16,753
Cash flows from financing activities
Issuance of common stock, net of offering expenses 210,582 11,422
Issuance of common stock from equity incentive plans 1,535 216
Finance lease principal payments - (54 )
Net cash provided by financing activities 212,117 11,584
Effect of exchange rate changes on cash and cash equivalents 511 262
Net increase (decrease) in cash and cash equivalents 34,803 (16,217 )
Cash and cash equivalents, beginning of year 15,789 32,006
Cash and cash equivalents, end of year $ 50,592 $ 15,789
Last updated: Jul 13, 2021