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KalVista Pharmaceuticals Reports First Fiscal Quarter Results - KVD900 On-Demand Data Expected Q4 2020 - Cambridge, MA and Salisbury, England

Key Takeaway: KalVista Pharmaceuticals Reports First Fiscal Quarter Results - KVD900 On-Demand Data Expected Q4 2020 - Cambridge, MA and Salisbury, England, September 14, 2020 - KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, d

Full Press Release Details

KalVista Pharmaceuticals Reports First Fiscal Quarter Results
- KVD900 On-Demand Data Expected Q4 2020 -
Cambridge, MA and Salisbury, England, September 14, 2020 - 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 first fiscal quarter ended July 31, 2020.
"We are pleased that our KVD900 Phase 2 trial has met its enrollment target and data is expected before the end of this year. We believe KVD900 can bring the first effective and well-tolerated oral on-demand treatment option to patients suffering from hereditary angioedema attacks," said Andrew Crockett, Chief Executive Officer of KalVista. "Our portfolio of oral options intended to treat HAE also includes prophylactic treatment candidate KVD824, for which we are completing our formulation studies which include dosing in subjects. We look forward to providing additional pharmacokinetic and pharmacodynamic data for KVD824 later this year in advance of starting a Phase 2 clinical trial. Similar to KVD900, our goal with KVD824 is to conduct a robust Phase 2 trial to provide proof-of-concept and potentially an expedited development pathway. We will provide further details on our plans as we prepare to initiate the trial."
First Fiscal Quarter and Recent Business Highlights:
First Fiscal Quarter Financial Results:
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. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the fourth quarter of 2020. KVD824 is in development for prophylactic treatment of HAE with a Phase 2 clinical trial planned to commence in late 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.
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, KalVista's expectations about future clinical trial timing and results, its ability to commence or complete clinical studies and to obtain regulatory approvals for KVD824, the ability of KVD900 and KVD824 to treat HAE, 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 its financial results are detailed in our annual report on Form 10-K filed on July 1, 2020, our quarterly report on Form 10-Q for the three months ended July 31, 2020, when filed, 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)
July 31, April 30,
2020 2020
Assets
Current assets:
Cash and cash equivalents $ 18,014 $ 15,789
Marketable securities 46,317 51,925
Research and development tax credit receivable 12,638 16,527
Prepaid expenses and other current assets 3,256 4,455
Total current assets 80,225 88,696
Property and equipment, net 2,019 2,043
Right of use assets 1,480 1,612
Other assets 178 178
Total assets $ 83,902 $ 92,529
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 1,774 $ 1,677
Accrued expenses 6,170 5,455
Lease liability - current portion 513 588
Total current liabilities 8,457 7,720
Long-term liabilities:
Lease liability - net of current portion 1,010 1,057
Total long-term liabilities 1,010 1,057
Stockholders' equity:
Common stock, $0.001 par value 18 18
Additional paid-in capital 208,442 207,208
Accumulated deficit (132,406 ) (121,592 )
Accumulated other comprehensive loss (1,619 ) (1,882 )
Total stockholders' equity 74,435 83,752
Total liabilities and stockholders' equity $ 83,902 $ 92,529
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
July 31,
2020 2019
Revenue $ - $ 3,369
Operating expenses:
Research and development 11,165 9,686
General and administrative 3,278 3,247
Total operating expenses 14,443 12,933
Operating loss (14,443 ) (9,564 )
Other income:
Interest income 259 590
Foreign currency exchange rate gain (loss) 438 (453 )
Other income 2,932 2,089
Total other income 3,629 2,226
Net loss $ (10,814 ) $ (7,338 )
Net loss per share, basic and diluted $ (0.61 ) $ (0.42 )
Weighted average common shares outstanding, basic and diluted 17,848,583 17,488,997
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
Three Months Ended
July 31,
2020 2019
Cash flows from operating activities
Net loss $ (10,814 ) $ (7,338 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 128 121
Stock-based compensation expense 1,188 1,074
Realized gain from sale of marketable securities (70 ) (29 )
Non-cash operating lease expense 8 1
Amortization of premium on marketable securities 68 35
Foreign currency exchange (gain) loss (432 ) 454
Changes in operating assets and liabilities:
Research and development tax credit receivable 4,462 (2,060 )
Prepaid expenses and other current assets 1,301 561
Accounts payable 35 392
Accrued expenses 538 (1,117 )
Deferred revenue - (3,369 )
Net cash used in operating activities (3,588 ) (11,275 )
Cash flows from investing activities
Purchases of marketable securities (9,807 ) (19,646 )
Sales and maturities of marketable securities 15,342 18,214
Acquisition of property and equipment (22 ) (98 )
Net cash provided by (used in) investing activities 5,513 (1,530 )
Cash flows from financing activities
Issuance of common stock, net of offering expenses - 11,422
Issuance of common stock from equity incentive plans 46 32
Finance lease principal payments - (54 )
Net cash provided by financing activities 46 11,400
Effect of exchange rate changes on cash and cash equivalents 254 (494 )
Net increase (decrease) in cash and cash equivalents 2,225 (1,899 )
Cash and cash equivalents at beginning of period 15,789 32,006
Cash and cash equivalents at end of period $ 18,014 $ 30,107
KalVista Pharmaceuticals, Inc.
Senior Director, Corporate Communications & Investor Relations
Last updated: Sep 14, 2020