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): February 29, 2016
CEMPRA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-35405 | 45-4440364 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer ID Number) |
| 6320 Quadrangle Drive, Suite 360, Chapel Hill, NC | 27517 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code (919) 313-6601
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)) |
| Item 1.01. | Entry into a Material Definitive Agreement. |
Effective February 29, 2016, our wholly owned subsidiary, Cempra Pharmaceuticals, Inc., entered into an amendment to its existing agreement with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (BARDA), for the evaluation and development of our lead product candidate solithromycin for the treatment of bacterial infections in pediatric populations and infections caused by bioterror threat pathogens, specifically anthrax and tularemia.
The amendment evidences the authorization by BARDA of a third option work segment of the agreement. The value of this option work segment is approximately $25.5 million, which is intended to fund a Phase 2/3 study of intravenous, oral capsule and oral suspension formulations of solithromycin in pediatric patients from newborn to 17 years with community acquired bacterial pneumonia. The estimated period of performance for this option work segment is February 2016 through May 2018. This option is a cost sharing arrangement for which we will be responsible for an additional designated portion of the costs associated with the work segment.
As previously reported, BARDA authorized the first option work segment in May 2013 and the second option work segment in November 2014. Under the agreement with BARDA, there are two remaining option work segments that BARDA may request in its sole discretion pursuant to the agreement. The two remaining option work segments and the two previously authorized segments are cost plus fixed fee arrangements.
The description of the amendment to the agreement with BARDA provided above is qualified in its entirety by reference to the full and complete terms contained in the amended agreement, which will be filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ending March 31, 2016.
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.
| CEMPRA, INC. | ||||
| Date: March 4, 2016 |
/s/ Mark W. Hahn | |||
| Mark W. Hahn, Chief Financial Officer | ||||