UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 3, 2019
KALVISTA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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Delaware |
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001-36830 |
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20-0915291 |
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(State or Other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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55 Cambridge Parkway Suite 901E Cambridge, Massachusetts 02142 |
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(Address of Principal Executive Offices) (Zip Code) |
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(857) 999-0075
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Common Stock, $0.001 par value |
KALV |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
On December 3, 2019, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal quarter ended October 31, 2019. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information furnished with Item 2.02 of this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
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Item 9.01. |
Financial Statements and Exhibits. |
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Exhibit |
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Description |
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99.1 |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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KALVISTA PHARMACEUTICALS, INC. |
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Date: December 3, 2019 |
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By: |
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/s/ Benjamin L. Palleiko |
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Benjamin L. Palleiko |
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Chief Business Officer and Chief Financial Officer |
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Exhibit 99.1
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:
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Presented at The International Symposium on Ocular Pharmacology and Therapeutics (ISOPT). KalVista’s Chief Scientific Officer, Edward P. Feener, PhD, spoke on “Kallikrein-Kinin System in Diabetic Retinopathy – Novel Target.” |
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Announced that the Phase 2 trial of KVD900 as an on-demand therapy for HAE is anticipated to complete enrollment in 2019 with data expected in 2020. The trial is being conducted in approximately 20 sites in Europe and the U.S. |
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Received Fast Track designation for KVD900 from the U.S. FDA, supporting the Company’s belief in the high level of unmet need in HAE and providing a potentially expedited path to drug approval. |
Fiscal Second Quarter Financial Results:
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Revenue: Revenue was $3.9 million for the three months ended October 31, 2019, compared to $5.6 million for the same period in 2018. Revenue in the three months ended October 31, 2019 consisted of the recognition of a portion of the upfront payment from Merck related to the agreement signed in October 2017. |
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R&D Expenses: Research and development expenses were $9.8 million for the three months ended October 31, 2019, compared to $7.9 million for the same period in 2018. The increase in R&D expense primarily reflects the ongoing clinical trial for KVD900 and an increase in expense related to preclinical activities. |
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G&A Expenses: General and administrative expenses were $3.4 million for the three months ended October 31, 2019, compared to $2.6 million for the same period in 2018. |
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Net Loss: Net loss was $5.9 million, or $(0.33) per basic and diluted share for the three months ended October 31, 2019, compared to a net loss of $3.3 million, or $(0.22) per basic and diluted share, for the same period in 2018. |
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Cash: Cash, cash equivalents and marketable securities were $93.5 million as of October 31, 2019. |
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.
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KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Balance Sheets |
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(in thousands, except share and per share amounts) |
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(Unaudited) |
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October 31, |
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April 30, |
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2019 |
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2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
21,719 |
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$ |
32,006 |
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Marketable securities |
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71,742 |
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68,805 |
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Research and development tax credit receivable |
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11,814 |
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11,315 |
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Prepaid expenses and other current assets |
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2,617 |
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3,420 |
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Total current assets |
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107,892 |
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115,546 |
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Right of use assets |
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1,634 |
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— |
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Property and equipment, net |
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2,365 |
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2,413 |
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Other assets |
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173 |
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173 |
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Total assets |
$ |
112,064 |
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$ |
118,132 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
$ |
2,238 |
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$ |
2,860 |
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Accrued expenses |
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5,029 |
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5,647 |
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Deferred revenue - current portion |
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2,601 |
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9,545 |
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Lease liability - current portion |
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602 |
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— |
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Total current liabilities |
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10,470 |
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18,052 |
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Long-term liabilities: |
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Deferred revenue - net of current portion |
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2,754 |
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3,342 |
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Lease liability - net of current portion |
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1,053 |
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— |
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Total long-term liabilities |
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3,807 |
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3,342 |
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Stockholders’ equity: |
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Common stock, $0.001 par value |
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18 |
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17 |
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Additional paid-in capital |
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204,950 |
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191,123 |
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Accumulated deficit |
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(105,717 |
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(92,476 |
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Accumulated other comprehensive loss |
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(1,464 |
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(1,926 |
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Total stockholders’ equity |
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97,787 |
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96,738 |
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Total liabilities and stockholders' equity |
$ |
112,064 |
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$ |
118,132 |
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KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Statement of Operations |
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(in thousands, except share and per share amounts) |
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(Unaudited) |
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Three Months Ended |
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Six Months Ended |
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October 31, |
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October 31, |
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2019 |
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2018 |
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2019 |
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2018 |
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Revenue |
$ |
3,920 |
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$ |
5,592 |
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$ |
7,289 |
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$ |
9,311 |
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Operating expenses: |
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Research and development |
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9,789 |
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7,876 |
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19,476 |
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16,232 |
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General and administrative |
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3,420 |
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2,609 |
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6,665 |
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4,979 |
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Total operating expenses |
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13,209 |
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10,485 |
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26,141 |
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21,211 |
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Operating loss |
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(9,289 |
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(4,893 |
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(18,852 |
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(11,900 |
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Other income: |
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Interest income |
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505 |
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204 |
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1,095 |
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293 |
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Foreign currency exchange gain (loss) |
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560 |
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(231 |
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108 |
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(165 |
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Other income |
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2,321 |
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1,616 |
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4,408 |
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3,438 |
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Total other income |
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3,386 |
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1,589 |
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5,611 |
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3,566 |
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Net loss |
$ |
(5,903 |
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$ |
(3,304 |
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$ |
(13,241 |
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$ |
(8,334 |
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Net loss per share, basic and diluted |
$ |
(0.33 |
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$ |
(0.22 |
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$ |
(0.75 |
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$ |
(0.64 |
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Weighted average common shares outstanding, basic and diluted |
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17,823,302 |
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15,108,272 |
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17,656,150 |
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12,954,083 |
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4
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KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Statements of Cash Flows |
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(in thousands, unaudited) |
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Six Months Ended |
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October 31, |
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2019 |
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2018 |
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Cash Flows from Operating Activities |
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Net loss |
$ |
(13,241 |
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$ |
(8,334 |
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Adjustments to reconcile net loss to net cash used in operating activities |
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Depreciation and amortization |
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248 |
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153 |
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Stock-based compensation expense |
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2,236 |
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1,323 |
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Realized (gain) loss from available for sale securities |
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(129 |
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— |
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Amortization of right of use assets |
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273 |
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— |
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Amortization of discount/premium on available for sale securities |
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79 |
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— |
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Foreign currency remeasurement (gain) loss |
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(81 |
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226 |
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Changes in operating assets and liabilities: |
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Research and development tax credit receivable |
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(577 |
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(692 |
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Prepaid expenses and other current assets |
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785 |
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(517 |
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Accounts payable |
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(558 |
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2,088 |
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Accrued expenses |
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(564 |
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66 |
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Lease obligations |
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(271 |
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— |
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Deferred revenue |
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(7,289 |
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(9,311 |
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Net cash used in operating activities |
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(19,089 |
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(14,998 |
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Cash Flows from Investing Activities |
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Acquisition of property and equipment |
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(212 |
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(786 |
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Purchases of available for sale securities |
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(42,561 |
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— |
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Sales and maturities of available for sale securities |
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39,729 |
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— |
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Net cash used in investing activities |
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(3,044 |
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(786 |
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Cash Flows from Financing Activities |
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Capital lease principal payments |
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(54 |
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(104 |
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Proceeds from issuance of common stock from equity incentive plans |
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170 |
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25 |
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Proceeds from issuance of common stock, net of $123 of offering expenses |
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11,422 |
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87,811 |
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Net cash provided by financing activities |
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11,538 |
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87,732 |
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Effect of exchange rate changes on cash and cash equivalents |
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308 |
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(1,887 |
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Net (decrease) increase in cash and cash equivalents |
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(10,287 |
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70,061 |
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Cash and cash equivalents, beginning of period |
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32,006 |
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51,055 |
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Cash and cash equivalents, end of period |
$ |
21,719 |
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$ |
121,116 |
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Contact:
KalVista Pharmaceuticals, Inc.
Leah Monteiro
Senior Director, Corporate Communications & Investor Relations
857-999-0808
leah.monteiro@kalvista.com
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