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): December 26, 2019

 

SPRING BANK PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Charter)

 

 

Delaware

001-37718

52-2386345

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

                                                               35 Parkwood Drive, Suite 210                                                                        

                                                           Hopkinton, MA 01748

 

 

                                                                         (Address of principal executive offices) (Zip Code)

 

 

Registrant’s telephone number, including area code: (508) 473-5993

 

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 Class

 

Trading

Symbol

 

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

SBPH

 

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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 

 

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 December 26, 2019, Spring Bank Pharmaceuticals, Inc. (the “Company”) announced that it has stopped dosing and enrolling patients in its Phase 2b CATALYST trials and its other inarigivir studies for the treatment of chronic hepatitis B virus (HBV).  The decision to stop the dosing of inarigivir 400mg in these trials was due to clinical findings observed in the CATALYST 2 trial of virally-suppressed chronic HBV patients. Laboratory findings revealed that three subjects participating in this trial showed evidence of hepatocellular dysfunction and an elevation of alanine transaminase (ALT) potentially consistent with liver injury rather than immune flares. The Company is investigating and analyzing the data to gain a better understanding of the findings and potential causes thereof and is further evaluating safety data across the almost 100 patients who have received inarigivir at this dose.

 



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 thereunto duly authorized.

 

 

SPRING BANK PHARMACEUTICALS, INC.

 

 

 

By:

/s/ Martin Driscoll

 

 

Martin Driscoll

 

 

President and Chief Executive Officer

 

 

 

Date: December 26, 2019