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KalVista Pharmaceuticals Reports Fiscal First Quarter Results - Phase 2 Clinical Trial of KVD900 for On-Demand Oral Treatment of Hereditary Angioedema (HAE) Attacks Expected to Complete in Late 2019 - - KVD001 Phase 2 Cl

Key Takeaway: KalVista Pharmaceuticals Reports Fiscal First Quarter Results - Phase 2 Clinical Trial of KVD900 for On-Demand Oral Treatment of Hereditary Angioedema (HAE) Attacks Expected to Complete in Late 2019 - - KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME

Full Press Release Details

KalVista Pharmaceuticals Reports Fiscal First Quarter Results
- Phase 2 Clinical Trial of KVD900 for On-Demand Oral Treatment of Hereditary Angioedema (HAE) Attacks Expected to Complete in Late 2019 -
- KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME) Data Expected in Q4 2019 -
Cambridge, MA and Salisbury, England September 9, 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 first quarter ended July 31, 2019.
"With enrollment complete in our Phase 2 trial for KVD001, we expect data in the fourth quarter of 2019," said Andrew Crockett, Chief Executive Officer of KalVista. "Our second ongoing Phase 2 trial, with KVD900 for on-demand treatment of hereditary angioedema attacks is currently enrolling, and we continue to expect to complete that trial late this year. On the research side, our team continues to work on our earlier stage programs including KVD824, for which we expect to announce further development plans in the first half of 2020."
First Quarter and Recent Business Highlights:
Fiscal First 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). 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 acute HAE attacks and commenced a Phase 2 proof-of-concept study in HAE patients in late 2018. In DME, KalVista's most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, began a Phase 2 clinical trial in 2017 that is anticipated to report data 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, potential 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 16, 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)
July 31, April 30,
2019 2019
Assets
Current assets:
Cash and cash equivalents $ 30,107 $ 32,006
Marketable securities 70,259 68,805
Research and development tax credit receivable 12,625 11,315
Prepaid expenses and other current assets 2,728 3,420
Total current assets 115,719 115,546
Right of use assets 1,737 -
Property and equipment, net 2,255 2,413
Other assets 173 173
Total assets $ 119,884 $ 118,132
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 3,103 $ 2,860
Accrued expenses 4,261 5,647
Deferred revenue - current portion 6,023 9,545
Lease liability - current portion 580 -
Total current liabilities 13,967 18,052
Long-term liabilities:
Deferred revenue - net of current portion 2,873 3,342
Lease liability - net of current portion 1,177 -
Total long-term liabilities 4,050 3,342
Stockholders' equity:
Common stock, $0.001 par value 18 17
Additional paid-in capital 203,650 191,123
Accumulated deficit (99,814 ) (92,476 )
Accumulated other comprehensive loss (1,987 ) (1,926 )
Total stockholders' equity 101,867 96,738
Total liabilities and stockholders' equity $ 119,884 $ 118,132
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
July 31,
2019 2018
Revenue $ 3,369 $ 3,718
Operating expenses:
Research and development 9,686 8,356
General and administrative 3,247 2,371
Total operating expenses 12,933 10,727
Operating loss (9,564 ) (7,009 )
Other income:
Interest income 590 89
Foreign currency exchange gain (loss) (453 ) 67
Other income 2,089 1,823
Total other income 2,226 1,979
Net loss $ (7,338 ) $ (5,030 )
Net loss per share, basic and diluted $ (0.42 ) $ (0.47 )
Weighted average common shares outstanding, basic and diluted 17,488,997 10,799,895
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
Three Months Ended
July 31,
2019 2018
Cash Flows from Operating Activities
Net loss $ (7,338 ) $ (5,030 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization 121 50
Stock-based compensation expense 1,074 347
Realized (gain) loss from available for sale securities (29 ) -
Amortization of right of use assets 138 -
Amortization of discount/premium on available for sale securities 35 -
Foreign currency remeasurement loss 454 6
Changes in operating assets and liabilities:
Research and development tax credit receivable (2,060 ) 919
Prepaid expenses and other current assets 561 (69 )
Other assets - -
Accounts payable 392 1,126
Accrued expenses (1,117 ) 157
Lease obligations (137 ) -
Deferred revenue (3,369 ) (3,718 )
Net cash used in operating activities (11,275 ) (6,212 )
Cash Flows from Investing Activities
Acquisition of property and equipment (98 ) (565 )
Purchases of available for sale securities (19,646 ) -
Sales and maturities of available for sale securities 18,214 -
Net cash used in investing activities (1,530 ) (565 )
Cash Flows from Financing Activities
Capital lease principal payments (54 ) (52 )
Proceeds from issuance of common stock from equity incentive plans 32 -
Proceeds from issuance of common stock, net of $123 of offering expenses 11,422 5,000
Net cash provided by financing activities 11,400 4,948
Effect of exchange rate changes on cash and cash equivalents (494 ) (1,156 )
Net decrease in cash and cash equivalents (1,899 ) (2,985 )
Cash and cash equivalents, beginning of period 32,006 51,055
Cash and cash equivalents, end of period $ 30,107 $ 48,070
KalVista Pharmaceuticals, Inc.
Senior Director, Corporate Communications & Investor Relations
Last updated: Sep 9, 2019