KalVista Pharmaceuticals Reports Fiscal Third Quarter Results
– Oral Hereditary Angioedema (HAE) Candidate KVD900 Phase 2 Trial Progressing –
– Intravitreal Diabetic Macular Edema (DME) Candidate KVD001 Phase 2 Trial Completion Expected H2 2019 –
– Oral Plasma Kallikrein Inhibitor Candidate KVD824 Dosing in First-in-Human Trial –
“We are pleased with the progress of the Phase 2 trial of KVD900 as we
move through the regulatory and site set-up process,” said
Third Quarter and Recent Business Highlights:
-
Provided a clinical update on oral plasma kallikrein inhibitors
currently in the clinic. KVD900 was advanced into a Phase 2 clinical
trial as a potential oral on-demand therapy, which will investigate
efficacy in at least 50 type 1 and type 2 HAE patients. The trial will
be conducted at 10-15 sites in the
UK ,Germany and other European countries. This two-part study will evaluate the pharmacodynamic and pharmacokinetic properties of KVD900 as well as the efficacy of the drug versus placebo. KVD824 was named as the next oral plasma kallikrein inhibitor candidate and has commenced dosing in a first-in-human trial. The Company expects to give an update on KVD824 around mid-2019. -
Appointed
Brian J. G. Pereira to Board of Directors. Brian is a veteran biopharmaceutical and healthcare leader with experience in financing and growing companies. He has been President and CEO ofVisterra, Inc. since 2013 and previously served as President and CEO ofAMAG Pharmaceuticals . Dr. Pereira’s experience in medical matters, clinical development and commercial infrastructure will be of great value to KalVista as we approach late stage development for our programs. -
Announced data from a poster presentation given at the
American Academy of Allergy , Asthma & Immunology (AAAAI) Annual Meeting. The Company provided additional data from a Phase 1 single ascending dose study of KVD900, evaluating the efficacy and safety of tablet and capsule formulations of the drug in healthy adult males, with a food-effect crossover study. The data showed that a single 600 mg dose of KVD900 provided >90% inhibition of plasma kallikrein within 30 minutes of dosing and protected against high molecular weight kininogen cleavage for at least 10 hours. No significant food effect was observed on the pharmacodynamic profile of the 600 mg KVD900 tablet in fed and fasted states.
Upcoming Events:
-
Presenting during a poster session at the
Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting,April 28 –May 2, 2019 , inVancouver, Canada :
Presentation Date:Monday, April 29, 2019
Presentation Time:4.00pm-5.45pm EST
Abstract Title: Novel oral plasma kallikrein (PKa) inhibitors KV998052 and KV998054 ameliorate VEGF-induced retinal thickening in a murine model of retina edema.
Session: 289
Session Title: Retinal Vascular Diseases II
Fiscal Third Quarter Financial Results:
-
Revenue: Revenue was
$3.9 million for the three months endedJanuary 31, 2019 , compared to$2.3 million for the same period in 2018. Revenue in the three months endedJanuary 31, 2019 consisted of the recognition of a portion of the upfront payment from Merck related to the agreement signed inOctober 2017 . -
R&D Expenses: Research and development expenses were
$7.7 million for the three months endedJanuary 31, 2019 , compared to$4.5 million for the same period in 2018. The increase in R&D expense primarily reflects the ongoing clinical trials for KVD001 and KVD900 and preparation for KVD824 to enter the clinic. -
G&A Expenses: General and administrative expenses were
$2.9 million for the three months endedJanuary 31, 2019 , compared to$2.1 million for the same period in 2018. -
Net Loss: Net loss was
$4.0 million , or$(0.23) per basic and diluted share for the three months endedJanuary 31, 2019 , compared to a net loss of$5.2 million , or$(0.49) per basic and diluted share, for the same period in 2018. -
Cash: Cash, cash equivalents and investments were
$111.1 million as ofJanuary 31, 2019 .
About
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
KalVista Pharmaceuticals Inc. | |||||||||||
Condensed Consolidated Balance Sheets | |||||||||||
(in thousands, except share and per share amounts) | |||||||||||
(Unaudited) | |||||||||||
January 31, | April 30, | ||||||||||
2019 | 2018 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | 56,345 | $ | 51,055 | |||||||
Investments | 54,802 | — | |||||||||
Research and development tax credit receivable | 8,970 | 6,834 | |||||||||
Prepaid expenses and other current assets | 3,946 | 1,491 | |||||||||
Total current assets | 124,063 | 59,380 | |||||||||
Other assets | 173 | 173 | |||||||||
Property and equipment, net | 2,289 | 1,836 | |||||||||
Total assets | $ | 126,525 | $ | 61,389 | |||||||
Liabilities and Stockholders' Equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | 2,998 | $ | 1,433 | |||||||
Accrued expenses | 3,408 | 3,087 | |||||||||
Deferred revenue - current portion | 12,311 | 18,475 | |||||||||
Capital lease liability - current portion | 109 | 221 | |||||||||
Total current liabilities | 18,826 | 23,216 | |||||||||
Long-term liabilities: | |||||||||||
Deferred revenue - net of current portion | 3,666 | 10,862 | |||||||||
Capital lease liability - net of current portion | — | 58 | |||||||||
Total long-term liabilities | 3,666 | 10,920 | |||||||||
Stockholders’ equity: | |||||||||||
Common stock, $0.001 par value | 17 | 11 | |||||||||
Additional paid-in capital | 190,067 | 100,011 | |||||||||
Accumulated deficit | (83,950 | ) | (71,660 | ) | |||||||
Accumulated other comprehensive loss | (2,101 | ) | (1,109 | ) | |||||||
Total stockholders’ equity | 104,033 | 27,253 | |||||||||
Total liabilities and stockholders' equity | $ | 126,525 | $ | 61,389 | |||||||
KalVista Pharmaceuticals Inc. | |||||||||||||||||||||
Condensed Consolidated Statement of Operations | |||||||||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
January 31, | January 31, | ||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||||||||
Revenue | $ | 3,890 | $ | 2,331 | $ | 13,201 | $ | 3,554 | |||||||||||||
Operating expenses: | |||||||||||||||||||||
Research and development | 7,650 | 4,548 | 23,882 | 12,385 | |||||||||||||||||
General and administrative | 2,900 | 2,129 | 7,879 | 6,905 | |||||||||||||||||
Total operating expenses | 10,550 | 6,677 | 31,761 | 19,290 | |||||||||||||||||
Operating loss | (6,660 | ) | (4,346 | ) | (18,560 | ) | (15,736 | ) | |||||||||||||
Other income: | |||||||||||||||||||||
Interest income | 723 | 14 | 1,016 | 17 | |||||||||||||||||
Foreign currency exchange rate gain (loss) | 248 | (1,887 | ) | 83 | (1,836 | ) | |||||||||||||||
Other income | 1,733 | 985 | 5,171 | 2,407 | |||||||||||||||||
Total other income | 2,704 | (888 | ) | 6,270 | 588 | ||||||||||||||||
Net loss | $ | (3,956 | ) | $ | (5,234 | ) | $ | (12,290 | ) | $ | (15,148 | ) | |||||||||
Net loss per share to common stockholders, basic and diluted | $ | (0.23 | ) | $ | (0.49 | ) | $ | (0.85 | ) | $ | (1.49 | ) | |||||||||
Weighted average common shares outstanding, basic and diluted | 17,231,449 | 10,788,556 | 14,379,872 | 10,168,520 | |||||||||||||||||
KalVista Pharmaceuticals Inc. | |||||||||||
Condensed Consolidated Statements of Cash Flows | |||||||||||
(in thousands, unaudited) | |||||||||||
Nine Months Ended | |||||||||||
January 31 | |||||||||||
2019 | 2018 | ||||||||||
Cash Flows from Operating Activities | |||||||||||
Net loss | $ | (12,290 | ) | $ | (15,148 | ) | |||||
Adjustments to reconcile net loss to net cash used in operating activities | |||||||||||
Depreciation and amortization | 256 | 129 | |||||||||
Stock-based compensation expense | 2,120 | 779 | |||||||||
Foreign currency remeasurement loss | (20 | ) | (500 | ) | |||||||
Changes in operating assets and liabilities: | |||||||||||
Research and development tax credit receivable | (2,409 | ) | (2,383 | ) | |||||||
Prepaid expenses and other current assets | (2,475 | ) | (1,206 | ) | |||||||
Grants and other receivables | — | 281 | |||||||||
Other Assets | — | (123 | ) | ||||||||
Accounts payable | 1,748 | 548 | |||||||||
Accrued expenses | 417 | 332 | |||||||||
Deferred revenue | (13,201 | ) | 33,804 | ||||||||
Net cash used in operating activities | (25,854 | ) | 16,513 | ||||||||
Cash Flows from Investing Activities | |||||||||||
Acquisition of property and equipment | (806 | ) | (343 | ) | |||||||
Purchases of available for sale securities | (55,419 | ) | — | ||||||||
Sales of available for sale securities | 850 | — | |||||||||
Net cash used in investing activities | (55,375 | ) | (343 | ) | |||||||
Cash Flows from Financing Activities | |||||||||||
Capital lease principal payments | (155 | ) | (101 | ) | |||||||
Issuance of common stock from stock option exercises | 132 | — | |||||||||
Issuance of common stock, net of offering expenses | 87,811 | 9,100 | |||||||||
Net cash provided by financing activities | 87,788 | 8,999 | |||||||||
Effect of exchange rate changes on cash and cash equivalents | (1,269 | ) | 2,559 | ||||||||
Net decrease in cash and cash equivalents | 5,290 | 27,728 | |||||||||
Cash and cash equivalents, beginning of period | 51,055 | 30,950 | |||||||||
Cash and cash equivalents, end of period | $ | 56,345 | $ | 58,678 | |||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190314005119/en/
Source:
KalVista Pharmaceuticals, Inc.
Leah Monteiro
Director,
Corporate Communications & Investor Relations
857-999-0808
leah.monteiro@kalvista.com