8-K

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 22, 2015

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 8.01 Other Events.

On December 22, 2015, we issued a press release announcing our entry into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID) to expand our ongoing Phase 3 solithromycin clinical trial in urogenital gonorrhea to include additional female patients and adolescents. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release dated December 22, 2015.

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: December 23, 2015	/s/ Mark W. Hahn
	Mark W. Hahn, Chief Financial Officer

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Cempra Enters into a CRADA with the NIAID and Expands the Phase 3 Solithromycin Clinical Trial in Urogenital

Gonorrhea to Include Additional Female Patients and Adolescents

CHAPEL HILL, N.C. – December 22, 2015 – Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it has successfully completed enrollment of 250 patients in the United States and Australia for its Phase 3 trial in urogenital gonorrhea. Under a CRADA (Cooperative Research and Development Agreement) with the National Institute of Allergy and Infectious Diseases (NIAID), the Phase 3 trial has been amended to include up to an additional 60 patients, consisting of women and adolescents with culture-proven gonorrhea.

“We have already completed patient enrollment of the first 250 patients, the majority of whom were men,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. “There is tremendous need for an effective, single dose, oral treatment such as solithromycin that can provide coverage for both gonococcus and chlamydia for the entire population at risk for these infections. We are pleased that the NIAID will be expanding this study to enroll the additional patient populations that could eventually be included for the label indication, should solithromycin be approved for the treatment of urogenital gonorrhea. This potential use could be an attractive secondary market, in addition to the primary indication we are seeking for the treatment of community-acquired bacterial pneumonia.”

Solithromycin as a single oral dose showed high efficacy in treating male and female patients in a Phase 2 trial in uncomplicated bacterial urethritis (Hook III EW et al. Clin. Infect. Dis. 61(7):1043-8 http://cid.oxfordjournals.org/content/early/2015/06/18/cid.civ478.abstract).

About Solitaire-U Phase 3 Clinical Trial

An oral solithromycin Phase 3 clinical trial, called Solitaire-U, is being conducted in patients with uncomplicated Neisseria gonorrhoeae and chlamydia infections in both Australia and the U.S. It has completed enrollment of 250 evaluable patients, the majority of whom are men, with culture-proven Neisseria gonorrhoeae. Solitaire-U is a randomized, two-arm study with a single oral dose of 1000 mg of solithromycin compared with the standard of care, 500 mg of ceftriaxone administered intramuscularly and 1000 mg of oral azithromycin. A planned amendment to the protocol will enroll up to an additional 60 patients, consisting of women and adolescents.

There is an urgent need for new antibiotics to treat gonorrhea, which is easily transmitted and the second most commonly reported notifiable infection in the US. CDC has declared gonorrhea to be among the top 3 urgent threats in the United States http://www.cdc.gov/drugresistance/threat-report-2013/). The most recent guidelines from the CDC for treatment of gonorrhea in the United States (http://www.cdc.gov/std/gisp) recommends only one treatment regimen, which is dual therapy with ceftriaxone and azithromycin. If solithromycin is approved for this indication, it could provide a convenient oral treatment for patients.

About Cempra, Inc.

Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra’s two lead product candidates are currently in advanced clinical development. Solithromycin (CEM-101) has successfully completed two Phase 3 clinical trials for community-acquired bacterial pneumonia (CABP) and is licensed to strategic commercial partner Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Solithromycin is also in a Phase 3 clinical trial for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Cempra is contracted with BARDA for the development of solithromycin for pediatric use. Three formulations, intravenous, oral capsules and a suspension formulation are in a Phase 1b trial in children from birth to 17 years of age. Taksta™ is Cempra’s second product candidate, which is being developed for acute bacterial skin and skin structure Infections (ABSSSI) and is also expected to be tested in an exploratory study for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra has also synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com.

Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; our and our strategic commercial partners’ ability to obtain FDA and foreign regulatory approval of our product candidates; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; our anticipated capital expenditures and our estimates regarding our capital requirements; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and Taksta; our ability to produce and sell any approved products and the price we are able to realize for those products; our ability to retain and hire necessary employees and to staff our operations appropriately; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; our ability to compete in our industry; our dependence on the success of solithromycin and Taksta; innovation by our

competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.

Contacts:

Investor Contact:

Robert H. Uhl

Westwicke Partners, LLC

(858) 356-5932

robert.uhl@westwicke.com

Media Contact:

Tony Plohoros

6 Degrees

(908) 591-2839

tplohoros@6degreespr.com

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