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, 2018.
“Our two recent financings provide significant additional capital for late stage development of KVD900, our oral plasma kallikrein inhibitor for potential treatment of on-demand acute attacks in patients with hereditary angioedema, or HAE,” said Andrew Crockett, Chief Executive Officer of KalVista. “KVD001, our intravitreal candidate for potential treatment of diabetic macular edema, or DME, currently enrolling a Phase 2 clinical trial, continues with data expected as planned in the second half of 2019. Additionally, we remain committed to our work in discovering and developing oral plasma kallikrein inhibitors for prophylactic treatment of HAE as well as DME. Finally, we recently moved to our new facility in Porton Down, England, which is intended to support our scientific team as they continue to work on discovery and development of additional drug programs.”
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 into Phase 1 clinical trials for HAE. The
Company has selected KVD900 as its program to be advanced as an
on-demand therapy for acute HAE attacks, and anticipates commencing 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 second half 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 30, 2018 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) |
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July 31, | April 30, | |||||||||||||
2018 | 2018 | |||||||||||||
Assets | ||||||||||||||
Current assets: | ||||||||||||||
Cash and cash equivalents | $ | 48,070 | $ | 51,055 | ||||||||||
Research and development tax credit receivable | 5,604 | 6,834 | ||||||||||||
Prepaid expenses and other current assets | 1,511 | 1,491 | ||||||||||||
Total current assets | 55,185 | 59,380 | ||||||||||||
Other assets | 173 | 173 | ||||||||||||
Property and equipment, net | 2,260 | 1,836 | ||||||||||||
Total assets | $ | 57,618 | $ | 61,389 | ||||||||||
Liabilities and Stockholders' Equity | ||||||||||||||
Current liabilities: | ||||||||||||||
Accounts payable | $ | 2,345 | $ | 1,433 | ||||||||||
Accrued expenses | 3,137 | 3,087 | ||||||||||||
Deferred revenue - current portion | 17,207 | 18,475 | ||||||||||||
Capital lease liability - current portion | 214 | 221 | ||||||||||||
Total current liabilities | 22,903 | 23,216 | ||||||||||||
Long-term liabilities: | ||||||||||||||
Deferred revenue - net of current portion | 8,465 | 10,862 | ||||||||||||
Capital lease liability - net of current portion | - | 58 | ||||||||||||
Total long-term liabilities | 8,465 | 10,920 | ||||||||||||
Stockholders’ equity: | ||||||||||||||
Common stock, $0.001 par value | 11 | 11 | ||||||||||||
Additional paid-in capital | 105,358 | 100,011 | ||||||||||||
Accumulated deficit | (76,690 | ) | (71,660 | ) | ||||||||||
Accumulated other comprehensive loss | (2,429 | ) | (1,109 | ) | ||||||||||
Total stockholders’ equity | 26,250 | 27,253 | ||||||||||||
Total liabilities and stockholders' equity | $ | 57,618 | $ | 61,389 | ||||||||||
KalVista Pharmaceuticals Inc. Condensed Consolidated Statement of Operations (in thousands, except share and per share amounts) (Unaudited) |
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Three Months Ended | ||||||||||||||
July 31, | ||||||||||||||
2018 | 2017 | |||||||||||||
Revenue | $ | 3,718 | $ | 96 | ||||||||||
Operating expenses: | ||||||||||||||
Research and development | 8,356 | 3,476 | ||||||||||||
General and administrative | 2,371 | 2,073 | ||||||||||||
Total operating expenses | 10,727 | 5,549 | ||||||||||||
Operating loss | (7,009 | ) | (5,453 | ) | ||||||||||
Other income: | ||||||||||||||
Interest income | 89 | 2 | ||||||||||||
Foreign currency exchange rate gain (loss) | 67 | (32 | ) | |||||||||||
Other income | 1,823 | 555 | ||||||||||||
Total other income | 1,979 | 525 | ||||||||||||
Net loss | $ | (5,030 | ) | $ | (4,928 | ) | ||||||||
Net loss per share to common stockholders, basic and diluted | $ | (0.47 | ) | $ | (0.51 | ) | ||||||||
Weighted average common shares outstanding, basic and diluted | 10,799,895 | 9,713,042 | ||||||||||||
KalVista Pharmaceuticals Inc. Condensed Consolidated Statements of Cash Flows (in thousands, unaudited) |
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Three Months Ended | ||||||||||||||
July 31 | ||||||||||||||
2018 | 2017 | |||||||||||||
Cash Flows from Operating Activities | ||||||||||||||
Net loss | $ | (5,030 | ) | $ | (4,928 | ) | ||||||||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||||||||
Depreciation and amortization | 50 | 32 | ||||||||||||
Stock-based compensation expense | 347 | 221 | ||||||||||||
Foreign currency remeasurement loss | 6 | 32 | ||||||||||||
Changes in operating assets and liabilities: | ||||||||||||||
Research and development tax credit receivable | 919 | (530 | ) | |||||||||||
Prepaid expenses and other current assets | (69 | ) | (85 | ) | ||||||||||
Grants and other receivables | — | 224 | ||||||||||||
Accounts payable | 1,126 | 771 | ||||||||||||
Accrued expenses | 157 | (185 | ) | |||||||||||
Deferred revenue | (3,718 | ) | — | |||||||||||
Net cash used in operating activities | (6,212 | ) | (4,448 | ) | ||||||||||
Cash Flows from Investing Activities | ||||||||||||||
Acquisition of property and equipment | (565 | ) | (110 | ) | ||||||||||
Net cash used in investing activities | (565 | ) | (110 | ) | ||||||||||
Cash Flows from Financing Activities | ||||||||||||||
Capital lease principal payments | (52 | ) | — | |||||||||||
Proceeds from issuance of common stock | 5,000 | — | ||||||||||||
Net cash provided by financing activities | 4,948 | — | ||||||||||||
Effect of exchange rate changes on cash and cash equivalents | (1,156 | ) | 64 | |||||||||||
Net decrease in cash and cash equivalents | (2,985 | ) | (4,494 | ) | ||||||||||
Cash and cash equivalents, beginning of period | 51,055 | 30,950 | ||||||||||||
Cash and cash equivalents, end of period | $ | 48,070 | $ | 26,456 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20180914005073/en/
KalVista Pharmaceuticals, Inc.
Leah Monteiro, 857-999-0808
Director,
Corporate Communications & Investor Relations
[email protected]