8-K
KalVista Pharmaceuticals, Inc. (KALV)
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): September 14, 2021
KALVISTA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36830 | 20-0915291 |
|---|---|---|
| (State or other jurisdiction<br><br><br>of incorporation) | (Commission<br><br><br>File Number) | (IRS Employer<br><br><br>Identification No.) |
| 55 Cambridge Parkway<br><br><br>Suite 901E<br><br><br>Cambridge, Massachusetts 02142 | ||
| --- | ||
| (Address of Principal Executive Offices) (Zip Code) |
(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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | 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:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered |
|---|---|---|
| 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 8.01 Other Events.
On September 14, 2021, KalVista Pharmaceuticals, Inc. (“KalVista”) announced the U.S. Food and Drug Administration (“FDA”) lifted the clinical hold on KalVista’s Phase 2 clinical trial of KVD824 (“KOMPLETE”) for oral prophylactic treatment of hereditary angioedema.
The previously announced clinical hold was removed after FDA review of KalVista’s responses to the FDA request for further information and analysis related to certain preclinical studies of KVD824. Refinements were also made to the KVD824 Phase 2 KOMPLETE protocol. KalVista is working closely with study investigators and clinical trial sites to proceed with all study activities as soon as possible.
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.
| KALVISTA PHARMACEUTICALS, INC. | ||
|---|---|---|
| Date: September 15, 2021 | By: | /s/ Benjamin L. Palleiko |
| Benjamin L. Palleiko | ||
| Chief Business Officer and Chief Financial Officer |