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): October 9, 2020
Axovant Gene Therapies Ltd.
(Exact name of registrant as specified in its charter)
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| Bermuda | | 001-37418 | | 98-1333697 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
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Suite 1, 3rd Floor 11-12 St. James's Square London SW1Y 4LB, United Kingdom (Address of principal executive offices) (Zip Code) |
(Registrant’s telephone number, including area code): +44 203 997 8931
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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 |
| Common Shares, par value $0.00001 per share | | AXGT | | 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 October 9 2020, Axovant Gene Therapies Ltd. issued a press release announcing that it has received Rare Pediatric Disease Designation from the U.S. Food and Drug Administration for AXO-AAV-GM1, an AAV9-based gene therapy delivered via a single intravenous administration that is in Phase 1/2 development for GM1 gangliosidosis. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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| | EXHIBIT INDEX |
| Exhibit No. | | Description of Document |
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| 99.1 | | |
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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| | | AXOVANT GENE THERAPIES LTD. | | |
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| Dated: | October 9, 2020 | | | | |
| | | By: | /s/ David Nassif | |
| | | Name: | David Nassif | |
| | | Title: | Principal Financial Officer and Principal Accounting Officer, General Counsel | |
