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): January 30, 2020
RUBIUS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38586 | 46-2688109 |
(State or other jurisdiction of Incorporation) | (Commission
File Number) | (IRS Employer Identification Number) |
399 Binney Street, Suite 300 Cambridge, MA | 02139 |
| (Address of registrant’s principal executive office) | (Zip code) |
(617) 679-9600
(Registrant’s telephone number, including area code)
N/A
(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 203.425)
¨ 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, par value $0.001 per share | | RUBY | | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth companyx
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 January 30, 2020, Rubius Therapeutics, Inc. (the “Company”) issued a press release announcing that the first patient has been dosed in its Phase 1b trial of RTX-134, an allogeneic, off-the-shelf cellular therapy for the potential treatment of patients with phenylketonuria (PKU). The trial is designed to evaluate the safety and pharmacokinetics of RTX-134 in adult patients with PKU.
The Company expects to report initial clinical data from the first patients enrolled in the trial, including preliminary safety, longevity of RTX-134 in circulation and proof-of-mechanism as measured by production of trans-cinnamic acid, a metabolite of phenylalanine when degraded by phenylalanine ammonia lyase. The Company plans to provide an update on timing of the initial data as the trial progresses.
A copy of the press release issued in connection with the announcement is attached hereto as Exhibit 99.1.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit
No. | | Description |
| | | |
| 99.1 | | Press Release issued by Rubius Therapeutics, Inc. on January 30, 2020. |
EXHIBIT INDEX
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.
| Date: January 31, 2020 | RUBIUS THERAPEUTICS, INC. |
| | |
| | |
| | By: | /s/ Pablo J. Cagnoni |
| | | Pablo J. Cagnoni |
| | | Chief Executive Officer |
