UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM8-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): April 1, 2019
CATALYST BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-51173 | 56-2020050 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
611 Gateway Blvd., Suite 710 South San Francisco, California | 94080 | |
| (Address of principal executive offices) | (Zip Code) |
(650) 871–0761
Registrant’s telephone number, including area code
Check the appropriate box below if the Form8-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 Rule14a-12 under the Exchange Act (17 CFR240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR240.13e-4(c)) |
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 Rule12b-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 |
Receipt of Orphan Designation from the European Commission for Marzeptacog Alfa (Activated)
On April 1, 2019, Catalyst Biosciences, Inc. (the “Company”) issued a press release announcing that the European Commission has awarded orphan designation of its Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for the treatment of haemophilia B (with or without inhibitors). A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form8-K and is incorporated herein by reference.
Initiation of a Phase 2b Trial of Dalcinonacog Alfa for the Treatment of Hemophilia B
On April 2, 2019, the Company issued a press release announcing the initiation of enrollment in a Phase 2b study of dalcinonacog alfa (DalcA), a next-generation subcutaneously (SQ) administered Factor IX (FIX) therapy being developed for the treatment of hemophilia B. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
Exhibit No. | Description | |
| 99.1 | Press Release dated April 1, 2019. | |
| 99.2 | Press Release dated April 2, 2019. | |
SIGNATURES
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.
| CATALYST BIOSCIENCES, INC. | ||||||
| Date: April 2, 2019 | /s/ Fletcher Payne | |||||
| Fletcher Payne | ||||||
| Chief Financial Officer | ||||||