SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 7, 2020
Kadmon Holdings, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
450 East 29th Street
New York, NY
(Address of principal executive offices)
Registrant’s telephone number, including area code (833) 900-5366
(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
Name of each exchange on which registered
Common stock, par value $0.001 per share
Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in 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 x
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. x
Regulation FD Disclosure.
On December 6, 2020, Kadmon Holdings, Inc. (the “Company”) issued a press release announcing that 12-month data from ROCKstar, its ongoing pivotal trial of belumosudil for the treatment of patients with chronic graft-versus-host disease (cGVHD), was presented in an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report.
The Company hosted a key opinion leader event on December 6th at 2:15 p.m., Eastern time, to discuss the 12-month data of the ROCKstar trial. The event is archived on the Company’s website. To access the webcast, please visit the Investors section of www.kadmon.com, under “Presentations & Events.”
The information in this Item 7.01, including Exhibit 99.1 hereto, is being “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of Section 18 of the Exchange Act. The information in this Item 7.01 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
As disclosed in Item 7.01, the Company announced 12-month data from its ROCKstar trial in an oral session at the ASH Annual Meeting on December 6th. The presentation slides shared by the Company during the oral presentation are filed herewith as Exhibit 99.2 to this Current Report.
Financial Statements and Exhibits.
Cover Page Interactive Data (embedded within Inline XBRL document)
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.
Kadmon Holdings, Inc.
Date: December 7, 2020
/s/ Harlan W. Waksal
Harlan W. Waksal
President and Chief Executive Officer