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): July 1, 2020
KALVISTA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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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 Per Share |
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. ☐
Item 2.02 Results of Operations and Financial Condition
On July 1, 2020, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal year ended April 30, 2020. 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 and 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit Number |
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Description |
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99.1 |
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Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, 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: July 1, 2020 |
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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 |
Exhibit 99.1
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
– KVD900 Phase 2 Clinical Trial for Oral Treatment of Hereditary Angioedema (HAE) Data Expected in 2H 2020 –
– Oral HAE Prophylactic Candidate KVD824 Phase 2 Clinical Trial Planned to Commence in 2H 2020 –
– Operations Funded into 2022 –
Cambridge, MA and Salisbury, England, July 1, 2020 – 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 year ended April 30, 2020.
“We have two oral candidates in clinical trials that have the potential to provide HAE patients with a complete set of options to treat their disease,” said Andrew Crockett, Chief Executive Officer of KalVista. “We are pleased with our progress with the formulation work for KVD824 to deliver a twice-daily treatment for prevention of HAE attacks. Subjects have begun dosing with these new formulations to obtain additional pharmacokinetic and pharmacodynamic data, and we look forward to providing these data later this year in advance of starting a Phase 2 clinical trial. Patients also continue to be treated in our Phase 2 clinical trial for KVD900 as an on-demand therapy, and we expect data from that trial in the second half of this year.”
Fiscal 2020 and Recent Business Highlights:
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Opened an Investigational New Drug (IND) Application for KVD900 with the U.S. Food and Drug Administration (FDA) to enable clinical development in the United States. |
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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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Received Fast Track designation for KVD900 from the FDA, supporting KalVista’s belief in the high level of unmet need in HAE for oral therapy and providing a potentially expedited path to drug approval. |
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Announced results of the Phase 2 trial of KVD001, an intravitreal candidate for treatment of diabetic macular edema (DME). KVD001 did not meet its primary endpoint in the overall study population, but it did demonstrate a protection against vision loss and a pre-specified subgroup analysis showed a clinical benefit on vision. The trial was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy. KVD001 was generally safe and well tolerated with no drug-related serious adverse events. Both KVD001 and future oral DME molecules were subject to an option agreement with Merck, which subsequently expired in February. |
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Adjusted expectations for KVD900 data to the second half of 2020 due to the impact of COVID-19, and revised financial guidance that activities are funded into at least early 2022. |
Fourth Quarter and Full Year Financial Results:
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Revenue: Revenue was $3.8 million for the three months ended April 30, 2020, compared to $2.9 million for the same period in the prior fiscal year. Revenue was $12.7 million for the fiscal year ended April 30, 2020, compared to $16.1 million for the prior fiscal year. All of the revenue recognized in the fiscal year ended April 30, 2020 was recognized from deferred revenue that existed at the beginning of the period. No future revenue exists under the Merck Option Agreement. |
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R&D Expenses: Research and development expenses were $9.5 million for the three months ended April 30, 2020, compared to $11.1 million for the same period in the prior fiscal year. The decrease in spending during the quarter was primarily due to the conclusion of the Phase 2 clinical trial for KVD001 in the previous quarter. Research and development expenses were $40.2 million for the fiscal year ended April 30, 2020, compared to $35.0 million for the prior fiscal year. The increase in spending in the fiscal year ended April 30, 2020 primarily reflects increased costs related to the ongoing clinical trial for KVD900 as well as increased expenses on preclinical activities. |
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G&A Expenses: General and administrative expenses were $3.3 million for the three months ended April 30, 2020, compared to $3.0 million for the same period in the prior fiscal year. General and administrative expenses were $13.0 million for the fiscal year ended April 30, 2020, compared to $10.9 million for the prior fiscal year. The increase in G&A expenses was primarily due to an increase in compensation related expenses and to a lesser extent, increases in commercial planning expenses, professional fees, and insurance costs. |
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related to the ramp up of research and development activities in the current year compared to the prior fiscal year. |
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Cash Position: Cash, cash equivalents and marketable securities were $67.7 million as of April 30, 2020, compared to $100.8 million as of April 30, 2019. The decrease in the net cash position was due to increased spending, primarily on research and development activities during the year ended April 30, 2020 compared to the prior fiscal year. |
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. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the second half of 2020. KVD824 is in development for prophylactic treatment of HAE and is expected to enter a Phase 2 clinical trial in the second half of 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 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, potential benefits of our product candidates, and the impact of COVID-19. Further information on potential risk factors that could affect our business and its financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2020 once filed, and our other reports that we may file 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.
Leah Monteiro
Senior Director, Corporate Communications & Investor Relations
857-999-0808
leah.monteiro@kalvista.com
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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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April 30, |
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April 30, |
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2020 |
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2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
15,789 |
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$ |
32,006 |
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Marketable securities |
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51,925 |
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68,805 |
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Research and development tax credit receivable |
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16,527 |
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11,315 |
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Prepaid expenses and other current assets |
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4,455 |
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3,420 |
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Total current assets |
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88,696 |
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115,546 |
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Property and equipment, net |
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2,043 |
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2,413 |
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Right of use assets |
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1,612 |
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— |
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Other assets |
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178 |
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173 |
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Total assets |
$ |
92,529 |
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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 |
$ |
1,677 |
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$ |
2,860 |
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Accrued expenses |
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5,455 |
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5,647 |
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Deferred revenue - current portion |
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— |
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9,545 |
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Lease liability - current portion |
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588 |
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— |
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Total current liabilities |
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7,720 |
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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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— |
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3,342 |
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Lease liability - net of current portion |
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1,057 |
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— |
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Total long-term liabilities |
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1,057 |
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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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207,208 |
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191,123 |
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Accumulated deficit |
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(121,592 |
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(92,476 |
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Accumulated other comprehensive loss |
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(1,882 |
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(1,926 |
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Total stockholders’ equity |
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83,752 |
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96,738 |
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Total liabilities and stockholders' equity |
$ |
92,529 |
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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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Years Ended |
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April 30, |
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April 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Revenue |
$ |
3,824 |
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$ |
2,926 |
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$ |
12,690 |
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$ |
16,127 |
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Operating expenses: |
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Research and development |
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9,485 |
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11,139 |
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40,194 |
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35,021 |
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General and administrative |
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3,296 |
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3,047 |
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13,029 |
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10,926 |
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Total operating expenses |
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12,781 |
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14,186 |
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53,223 |
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45,947 |
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Operating loss |
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(8,957 |
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(11,260 |
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(40,533 |
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(29,820 |
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Other income: |
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Interest income |
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363 |
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381 |
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1,830 |
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1,397 |
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Foreign currency exchange rate gain (loss) |
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(613 |
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(34 |
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(367 |
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49 |
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Other income |
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2,498 |
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2,511 |
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9,830 |
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7,682 |
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Total other income |
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2,248 |
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2,858 |
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11,293 |
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9,128 |
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Loss before income taxes |
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(6,709 |
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(8,402 |
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(29,240 |
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(20,692 |
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Income tax (benefit) expense |
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(124 |
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124 |
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(124 |
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124 |
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Net loss |
$ |
(6,585 |
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$ |
(8,526 |
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$ |
(29,116 |
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$ |
(20,816 |
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Net loss per share, basic and diluted |
$ |
(0.37 |
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$ |
(0.49 |
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$ |
(1.64 |
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$ |
(1.38 |
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Weighted average common shares outstanding, basic and diluted |
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17,845,599 |
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17,253,938 |
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17,748,666 |
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15,080,863 |
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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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Years Ended |
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April 30, |
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2020 |
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2019 |
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Cash flows from operating activities |
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Net loss |
$ |
(29,116 |
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$ |
(20,816 |
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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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512 |
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378 |
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Stock-based compensation expense |
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4,448 |
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2,966 |
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Realized (gain) from sale of marketable securities |
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(300 |
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(23 |
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Non-cash operating lease expense |
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13 |
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— |
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Amortization of premium on available for sale securities |
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193 |
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— |
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Foreign currency exchange (gain) loss |
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74 |
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(80 |
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Changes in operating assets and liabilities: |
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Research and development tax credit receivable |
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(5,781 |
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(4,883 |
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Prepaid expenses and other current assets |
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(1,112 |
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(1,979 |
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Other assets |
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(5 |
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— |
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Accounts payable |
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(1,004 |
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1,534 |
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Accrued expenses |
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(48 |
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2,665 |
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Deferred revenue |
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(12,690 |
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(16,127 |
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Net cash used in operating activities |
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(44,816 |
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(36,365 |
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Cash flows from investing activities |
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Purchases of available for sale securities |
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(49,797 |
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(79,889 |
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Sales and maturities of available for sale securities |
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66,770 |
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11,548 |
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Acquisition of property and equipment |
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(220 |
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(1,081 |
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Net cash provided by (used in) investing activities |
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16,753 |
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(69,422 |
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Cash flows from financing activities |
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Issuance of common stock, net of offering expenses |
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11,422 |
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87,910 |
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Issuance of common stock from equity incentive plans |
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216 |
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242 |
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Finance lease principal payments |
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(54 |
) |
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(209 |
) |
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Net cash provided by financing activities |
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11,584 |
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87,943 |
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Effect of exchange rate changes on cash and cash equivalents |
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262 |
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(1,205 |
) |
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Net decrease in cash and cash equivalents |
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(16,217 |
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(19,049 |
) |
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Cash and cash equivalents, beginning of year |
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32,006 |
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|
51,055 |
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Cash and cash equivalents, end of year |
$ |
15,789 |
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$ |
32,006 |
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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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