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KalVista Pharmaceuticals Reports Fiscal Second Quarter Results - KVD900 Phase 2 Trial Data for On-Demand Treatment of HAE Expected in 2020 - - KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME)

Key Takeaway: KalVista Pharmaceuticals Reports Fiscal Second Quarter Results - KVD900 Phase 2 Trial Data for On-Demand Treatment of HAE Expected in 2020 - - KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME) Data Expected This Month - - KVD900 Receives FDA Fast Tra

Full Press Release Details

KalVista Pharmaceuticals Reports Fiscal Second Quarter Results
- KVD900 Phase 2 Trial Data for On-Demand Treatment of HAE Expected in 2020 -
- KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME) Data Expected This Month -
- KVD900 Receives FDA Fast Track Designation -
Cambridge, MA and Salisbury, England, December 3, 2019 - 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 second quarter ended October 31, 2019.
"We recently received Fast Track designation for KVD900, illustrating the high level of unmet need in the HAE community for efficacious and safe, orally-delivered therapies," said Andrew Crockett, Chief Executive Officer of KalVista. "Our Phase 2 clinical trial for KVD900 continues, and we expect to have data from that trial in 2020. The Phase 2 clinical trial of KVD001 in DME will provide data this month."
Second Quarter and Recent Business Highlights:
Fiscal Second 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 Company's 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). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. The Company has selected KVD900 as its program to be advanced as an on-demand therapy for HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients that is expected to provide data in 2020. In DME, KalVista's most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, is anticipated to report data from a Phase 2 clinical trial in the fourth quarter of 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 that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway and future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 15, 2019 and other reports as filed 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.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
October 31, April 30,
2019 2019
Assets
Current assets:
Cash and cash equivalents $ 21,719 $ 32,006
Marketable securities 71,742 68,805
Research and development tax credit receivable 11,814 11,315
Prepaid expenses and other current assets 2,617 3,420
Total current assets 107,892 115,546
Right of use assets 1,634 -
Property and equipment, net 2,365 2,413
Other assets 173 173
Total assets $ 112,064 $ 118,132
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 2,238 $ 2,860
Accrued expenses 5,029 5,647
Deferred revenue - current portion 2,601 9,545
Lease liability - current portion 602 -
Total current liabilities 10,470 18,052
Long-term liabilities:
Deferred revenue - net of current portion 2,754 3,342
Lease liability - net of current portion 1,053 -
Total long-term liabilities 3,807 3,342
Stockholders' equity:
Common stock, $0.001 par value 18 17
Additional paid-in capital 204,950 191,123
Accumulated deficit (105,717 ) (92,476 )
Accumulated other comprehensive loss (1,464 ) (1,926 )
Total stockholders' equity 97,787 96,738
Total liabilities and stockholders' equity $ 112,064 $ 118,132
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
October 31, October 31,
2019 2018 2019 2018
Revenue $ 3,920 $ 5,592 $ 7,289 $ 9,311
Operating expenses:
Research and development 9,789 7,876 19,476 16,232
General and administrative 3,420 2,609 6,665 4,979
Total operating expenses 13,209 10,485 26,141 21,211
Operating loss (9,289 ) (4,893 ) (18,852 ) (11,900 )
Other income:
Interest income 505 204 1,095 293
Foreign currency exchange gain (loss) 560 (231 ) 108 (165 )
Other income 2,321 1,616 4,408 3,438
Total other income 3,386 1,589 5,611 3,566
Net loss $ (5,903 ) $ (3,304 ) $ (13,241 ) $ (8,334 )
Net loss per share, basic and diluted $ (0.33 ) $ (0.22 ) $ (0.75 ) $ (0.64 )
Weighted average common shares outstanding, basic and diluted 17,823,302 15,108,272 17,656,150 12,954,083
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
Six Months Ended
October 31,
2019 2018
Cash Flows from Operating Activities
Net loss $ (13,241 ) $ (8,334 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization 248 153
Stock-based compensation expense 2,236 1,323
Realized (gain) loss from available for sale securities (129 ) -
Amortization of right of use assets 273 -
Amortization of discount/premium on available for sale securities 79 -
Foreign currency remeasurement (gain) loss (81 ) 226
Changes in operating assets and liabilities:
Research and development tax credit receivable (577 ) (692 )
Prepaid expenses and other current assets 785 (517 )
Accounts payable (558 ) 2,088
Accrued expenses (564 ) 66
Lease obligations (271 ) -
Deferred revenue (7,289 ) (9,311 )
Net cash used in operating activities (19,089 ) (14,998 )
Cash Flows from Investing Activities
Acquisition of property and equipment (212 ) (786 )
Purchases of available for sale securities (42,561 ) -
Sales and maturities of available for sale securities 39,729 -
Net cash used in investing activities (3,044 ) (786 )
Cash Flows from Financing Activities
Capital lease principal payments (54 ) (104 )
Proceeds from issuance of common stock from equity incentive plans 170 25
Proceeds from issuance of common stock, net of $123 of offering expenses 11,422 87,811
Net cash provided by financing activities 11,538 87,732
Effect of exchange rate changes on cash and cash equivalents 308 (1,887 )
Net (decrease) increase in cash and cash equivalents (10,287 ) 70,061
Cash and cash equivalents, beginning of period 32,006 51,055
Cash and cash equivalents, end of period $ 21,719 $ 121,116
KalVista Pharmaceuticals, Inc.
Senior Director, Corporate Communications & Investor Relations
Last updated: Dec 3, 2019