UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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(Address of Principal Executive Offices) (Zip Code)
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(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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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 September 9, 2021, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal quarter ended July 31, 2021. 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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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
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: September 9, 2021 |
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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 Reports First Fiscal Quarter Results
– FDA End-of-Phase 2 Meeting for KVD900 Oral HAE Phase 3 Program Scheduled for This Month –
– KVD824 Phase 2 KOMPLETE Clinical Trial Enrolling –
Cambridge, MA and Salisbury, England, September 9, 2021 – 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 first fiscal quarter ended July 31, 2021.
“We have made excellent progress in the rollout of our Phase 2 KOMPLETE clinical trial for KVD824,” said Andrew Crockett, Chief Executive Officer of KalVista. “Site initiations are underway, and patients are being enrolled in the trial to evaluate KVD824 as a potential oral prophylactic treatment for HAE. We will be having an end-of-Phase 2 meeting with the FDA later this month regarding KVD900, our oral on-demand candidate for treatment of HAE attacks and are ready to initiate the Phase 3 study quickly afterwards. We look forward to advancing both of these compounds as we continue with our strategy of bringing a full spectrum of oral treatment options to HAE patients.”
First Fiscal Quarter and Recent Business Highlights:
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Presented Phase 2 data for KVD900 in late-breaking session at European Academy of Allergy and Clinical Immunology (EAACI) Congress. The data showed that a single on-demand treatment with orally administered KVD900 significantly slows progression and accelerates resolution of attacks in patients with hereditary angioedema (HAE). KalVista also presented four other posters at EAACI related to the HAE clinical landscape and unmet needs, as well as preclinical data from other oral molecules. |
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Scheduled an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review the proposed development plans for KVD900, KalVista’s oral on-demand candidate for treatment of HAE attacks, expected to take place in September 2021. KVD900 also received Orphan Drug Designation from the FDA. |
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Presented data at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress showcasing small molecule Factor XIIa inhibitor research. |
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Provided a progress update on the KVD824 Phase 2 KOMPLETE Clinical Trial. KVD824 is in development for oral prophylactic treatment of HAE. Regulatory submissions have been approved in Canada, Australia, and the UK with patient enrollment now underway. KalVista also submitted a response to the clinical hold related to the U.S. Investigational New Drug (IND) filing for KVD824 and is prepared to initiate the study in the U.S. upon clearance from the FDA. |
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Presented KVD001 data at American Chemical Society (ACS) Meeting. |
First Fiscal Quarter Financial Results:
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Revenue: No revenue was recognized for the three months ended July 31, 2021 or July 31, 2020. |
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R&D Expenses: Research and development expenses were $13.7 million for the three months ended July 31, 2021, compared to $11.2 million for the same period in the prior fiscal year. The increase in R&D expenses during the quarter primarily reflects increased preclinical spending and the ongoing clinical trial for KVD824, offset by a decrease in spending on KVD900 and KVD001 due to their concluded Phase 2 clinical trials in February 2021 and December 2019, respectively. |
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G&A Expenses: General and administrative expenses were $5.9 million for the three months ended July 31, 2021, compared to $3.3 million for the same period in 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 other administrative costs. |
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Net Loss: Net loss was $16.1 million, or $(0.66) per weighted average basic and diluted share, for the three months ended July 31, 2021, compared to net loss of $10.8 million, or $(0.61) per weighted average basic and diluted share for the same period in the prior fiscal year. The increase in net loss and net loss per share primarily resulted from the increase in operating expenses, primarily research and development. |
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Cash Position: Cash, cash equivalents and marketable securities were $230.6 million as of July 31, 2021, compared to $248.9 million as of April 30, 2021. The decrease in the net cash position was due to increased operating expenses. |
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. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista is developing KVD900 as an oral on-demand therapy for acute HAE attacks, which completed a Phase 2 efficacy trial in February 2021, demonstrating statistical and clinical significance across all endpoints. KVD824 is in development for prophylactic treatment of HAE with the Phase 2 KOMPLETE clinical trial underway. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of HAE for patients. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.
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, including the potential impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence or complete clinical studies, including our Phase 2 KOMPLETE clinical trial, and to obtain regulatory approvals for KVD900, KVD824 and other candidates in development, our ability to resolve a clinical hold with regards to KVD824,
the ability of KVD900, KVD824 and other candidates in development to treat HAE or DME, the future progress and potential success of our oral Factor XIIa program, and the sufficiency of our cash, cash equivalents and investments to fund our operations. Further information on potential risk factors that could affect our business and 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, 2021, our quarterly reports on Form 10-Q, and our other reports that we may make 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.
Contact:
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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July 31, |
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April 30, |
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2021 |
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2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
48,343 |
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$ |
50,592 |
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Marketable securities |
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182,288 |
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198,337 |
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Research and development tax credit receivable |
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13,613 |
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10,418 |
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Prepaid expenses and other current assets |
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5,538 |
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4,917 |
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Total current assets |
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249,782 |
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264,264 |
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Property and equipment, net |
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1,944 |
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1,791 |
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Right of use assets |
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7,207 |
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5,758 |
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Other assets |
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200 |
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200 |
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Total assets |
$ |
259,133 |
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$ |
272,013 |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
$ |
1,448 |
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$ |
1,981 |
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Accrued expenses |
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5,876 |
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6,930 |
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Lease liability - current portion |
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905 |
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863 |
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Total current liabilities |
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8,229 |
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9,774 |
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Long-term liabilities: |
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Lease liability - net of current portion |
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6,474 |
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5,046 |
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Total long-term liabilities |
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6,474 |
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5,046 |
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Stockholders’ equity: |
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Common stock, $0.001 par value |
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24 |
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24 |
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Additional paid-in capital |
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429,840 |
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426,437 |
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Accumulated deficit |
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(183,945 |
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(167,836 |
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Accumulated other comprehensive loss |
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(1,489 |
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(1,432 |
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Total stockholders’ equity |
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244,430 |
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257,193 |
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Total liabilities and stockholders' equity |
$ |
259,133 |
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$ |
272,013 |
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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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July 31, |
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2021 |
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2020 |
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Revenue |
$ |
— |
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$ |
— |
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Operating expenses: |
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Research and development |
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13,669 |
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11,165 |
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General and administrative |
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5,847 |
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3,278 |
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Total operating expenses |
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19,516 |
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14,443 |
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Operating loss |
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(19,516 |
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(14,443 |
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Other income: |
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Interest income |
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274 |
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259 |
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Foreign currency exchange rate (loss) gain |
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(51 |
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438 |
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Other income |
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3,184 |
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2,932 |
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Total other income |
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3,407 |
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3,629 |
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Net loss |
$ |
(16,109 |
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$ |
(10,814 |
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Net loss per share, basic and diluted |
$ |
(0.66 |
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$ |
(0.61 |
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Weighted average common shares outstanding, basic and diluted |
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24,429,919 |
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17,848,583 |
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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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Three Months Ended |
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July 31, |
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2021 |
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2020 |
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Cash flows from operating activities |
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Net loss |
$ |
(16,109 |
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$ |
(10,814 |
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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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132 |
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128 |
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Stock-based compensation expense |
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2,795 |
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1,188 |
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Realized loss (gain) from sale of marketable securities |
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23 |
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(70 |
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Non-cash operating lease expense |
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22 |
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8 |
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Amortization of premium on marketable securities |
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753 |
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68 |
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Foreign currency exchange loss (gain) |
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14 |
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(432 |
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Changes in operating assets and liabilities: |
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Research and development tax credit receivable |
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(3,211 |
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4,462 |
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Prepaid expenses and other current assets |
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(625 |
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1,301 |
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Accounts payable |
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(528 |
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35 |
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Accrued expenses |
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(1,001 |
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538 |
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Net cash used in operating activities |
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(17,735 |
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(3,588 |
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Cash flows from investing activities |
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Purchases of marketable securities |
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(19,036 |
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(9,807 |
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Sales and maturities of marketable securities |
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34,204 |
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15,342 |
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Acquisition of property and equipment |
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(287 |
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(22 |
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Net cash provided by investing activities |
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14,881 |
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5,513 |
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Cash flows from financing activities |
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Issuance of common stock from equity incentive plans |
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608 |
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46 |
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Net cash provided by financing activities |
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608 |
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46 |
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Effect of exchange rate changes on cash and cash equivalents |
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(3 |
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254 |
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Net (decrease) increase in cash and cash equivalents |
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(2,249 |
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2,225 |
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Cash and cash equivalents at beginning of period |
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50,592 |
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15,789 |
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Cash and cash equivalents at end of period |
$ |
48,343 |
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$ |
18,014 |
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