Autolus Therapeutics plc filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
$AUTL
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
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): November 8, 2024
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Item 7.01 Regulation FD Disclosure.
As described in Item 8.01 below, on November 8, 2024, Autolus Therapeutics plc (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has granted marketing approval for AUCATZYL® (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
On November 11, 2024, the Company made a corporate presentation via teleconference to discuss the approval of AUCATZYL®. The slides used during the presentation are furnished as Exhibit 99.2 hereto and are posted on the Company’s corporate website at www.autolus.com under “Investor Relations—Corporate Presentations.”
The press release contained an incorrect reference to the approval date, which as noted above was November 8, 2024. Exhibit 99.1 furnished with this report has been corrected accordingly.
The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, 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 liability of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing. Information contained in, or that can be accessed through, our website is not a part of, and shall not be incorporated by reference into, this report. We have included our website address in this report solely as an inactive textual reference.
Item 8.01 Other Events.
On November 8, 2024, the Company was notified by the FDA that its Biologics License Application for AUCATZYL® (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia has been approved.
Item 9.01 Exhibits
d) Exhibits
| Exhibit No. | Description of Exhibit | |||||||
| 104 | Cover Page Interactive Date File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
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.
| AUTOLUS THERAPEUTICS PLC | ||||||||
Dated: November 12, 2024 | By: | /s/Christian Itin, Ph.D. | ||||||
| Name: Christian Itin, Ph.D. | ||||||||
| Title: Chief Executive Officer | ||||||||