Cempra, Inc. Reports Fourth Quarter and Full Year 2013 Financial and Operating Results

Cempra, Inc. Reports Fourth Quarter and Full Year 2013 Financial and Operating
Results

Company to Host Conference Call and Webcast at 4:30 p.m. EST, Today, Feb. 27,
2014

CHAPEL HILL, N.C., Feb. 27, 2014 (GLOBE NEWSWIRE) -- 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 reported financial results for the fourth quarter
and full year ended Dec. 31, 2013. The company will host a conference call and
webcast at 4:30 p.m. EST, today.

"2013 has been a year of significant achievement for Cempra through the
advancement of our Phase 3 and Phase 2 clinical programs and the strengthening
of our financial position," said Prabhavathi Fernandes, Ph.D., chief executive
officer of Cempra. "SOLITAIRE-Oral continues to enroll patients and we
initiated our SOLITAIRE-IV trial in December. Also in December, we provided a
positive update on the Taksta Phase 2 trial in prosthetic joint infections, or
PJI, as well as the granting of Orphan Drug Status for Taksta for this
indication by the FDA. Orphan Drug status may enable us to progress more
rapidly toward filing an NDA, and strengthens our exclusivity position.
Earlier in the year, we presented data on the solithromycin Phase 2 gonorrhea
study in which 100 percent of patients with culture-proven infections were
cured regardless of the site of infection. We also announced the results of
the solithromycin hepatic insufficiency study in which solithromycin
demonstrated safety and tolerability in patients with mild to severe liver
disease, and recently announced the results from the Thorough QT study, where
solithromycin demonstrated no QT effects.

"Also in 2013, we signed an exclusive license and development agreement for
solithromycin for the Japanese market with Toyama Chemical Co., Ltd. Cempra
received an upfront payment of $10 million, and could receive up to $60
million in milestone payments based on the achievement of certain objectives.
We also were awarded a five-year contract with the Biomedical Advanced
Research and Development Authority, or BARDA, valued at up to $58 million if
all options are authorized by BARDA, for the development of solithromycin to
treat infections in pediatric populations and for the treatment of infections
by bioterror threat pathogens. The BARDA-funded work is ongoing. Finally, we
strengthened our financial position through a public offering of Cempra's
common stock, from which we raised approximately $54.2 million after fees."

Financial Results

Quarter ended Dec. 31, 2013 compared to quarter ended Dec. 31, 2012

Net loss in the quarter ended Dec. 31, 2013, was $16.8 million, or $0.51 per
share, compared to a net loss of $6.6 million, or $0.27 per share, for the
same period in 2012.

Revenue was $2.1 million from our contract with BARDA for the development of
solithromycin to treat infections in pediatric populations and for the
treatment of infections by bio-terror threat pathogens. Research and
development expense in the quarter ended Dec. 31, 2013, was $15.7 million, an
increase of 257% compared to the same quarter in 2012. The higher R&D expense
was primarily due to our SOLITAIRE-Oral phase 3 trial and the initiation of
the SOLITAIRE-IV phase 3 trial as well as pre-clinical studies related to the
BARDA contract. General and administrative expense was $2.5 million, a 39%
increase compared to the quarter ended Dec. 31, 2012, driven primarily by
employee cost and professional service fees.

Year ended Dec. 31, 2013 compared to year ended Dec. 31, 2012

For the year ended Dec. 31, 2013, Cempra reported a net loss of $45.0 million,
or $1.53 per share, compared to a net loss of $24.5 million, or $1.23 per
share, for the comparable period in the year ended Dec. 31, 2012.

Revenue in 2013 was $7.8 million consisting of $4.3 million from a $10 million
upfront payment from Toyama Chemical Co., Ltd, received during the second
quarter, for an exclusive license and development agreement for solithromycin
in Japan and $3.5 million for work performed under our BARDA contract. The
remaining $5.7 million of the upfront payment from the agreement with Toyama
was recorded as deferred revenue on the balance sheet. The majority of the
deferred revenue would be recognized as solithromycin is launched.

Research and development expense was $41.3 million, an increase of 144%
compared to the year ended Dec. 31, 2012. The increase was due to our ongoing
SOLITAIRE-Oral phase 3 trial, the initiation of our SOLITAIRE-IV phase 3
trial, acquisition of clinical trial materials and pre-clinical studies
related to the BARDA contract. Expenses also increased as we added personnel
to our clinical team to manage our multiple ongoing trials and from stock
compensation expenses. General & Administrative expense was $9.4 million, a
54% increase compared to the year ended Dec. 31, 2012 primarily due to
increases in employee cost and professional service fees.

At Dec. 31, 2013, Cempra had cash and equivalents of $96.5 million. The
increase compared to Dec. 31, 2012 was primarily due to proceeds from the
public offering of common stock, the upfront payment from the Toyama
agreement, payments for work under the BARDA contract and a $5 million draw on
a venture debt arrangement less operating expenses incurred during the year.

Fourth Quarter 2013 and early 2014 Highlights

  *Initiated SOLITAIRE-IV, Cempra's global solithromycin intravenous
    (IV)-to-oral Phase 3 clinical trial, in patients with CABP. SOLITAIRE-IV
    joins SOLITAIRE-Oral, the first global Phase 3 study of solithromycin in
    CABP patients
    
  *Reported positive results-to-date from the randomized open-label Phase 2
    study designed to evaluate Taksta compared to the standard of care in
    patients with prosthetic joint infections
    
  *Taksta received orphan drug designation by the U.S. Food and Drug
    Administration (FDA) for the treatment of prosthetic joint infections
    
  *Reported results of an in vivo preclinical study suggesting that
    solithromycin may provide an effective antimicrobial approach for the
    prevention and treatment of intrauterine infections during pregnancy
    
  *David Moore joined Cempra as chief commercial officer
    
  *Solithromycin demonstrated no QT effects in a Thorough QT study
    
  *The BARDA-funded pediatric program was initiated by dosing of the first
    patient in a Phase 1 trial

Clinical program update

The company is focused on the development of its two lead clinical-stage
antibiotic candidates, the fluoroketolide, solithromycin, and Taksta™, the
oral antibiotic being developed for staphylococcal infections.The company
expects the following events to occur:

Solithromycin

4Q 14:Completion of SOLITAIRE-Oral Phase 3 patient enrollment

1Q 15: Report top-line data from SOLITAIRE-Oral Phase 3

Taksta

1H 14:Feedback obtained from the FDA on the Phase 3 plan for Taksta

Financial Guidance

Cempra expects its research and development expense to increase in the first
half of the year due to the concurrent running of its two phase 3 programs for
solithromycin as well as its other programs.The company's cash and
equivalents are expected to be sufficient to fund current operations through
2015, based on current assumptions. This projection does not include any funds
from future financings or partnerships beyond the Toyama relationship.

Conference Call and Webcast

The conference call may be accessed by dialing 877-377-7553 for domestic
callers and 253-237-1151 for international callers. Please specify to the
operator that you would like to join the "Cempra, Inc., Fourth Quarter and
Full Year 2013 Financial Results Call, conference ID#: 2739816." The
conference call will be webcast live under the investor relations section of
Cempra's website at www.cempra.com, and will be archived there for 30 days
following the call. Please visit Cempra's website several minutes prior to the
start of the broadcast to ensure adequate time for any software download that
may be necessary.

About Cempra, Inc.

Founded in 2006, 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) is in a Phase 3 clinical trial 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. TAKSTA™ (CEM-102) is Cempra's second product
candidate, which is currently in a Phase 2 clinical trial for prosthetic joint
infections. Both seek to address the need for new treatments targeting
drug-resistant bacterial infections in the hospital and in the community. The
company also intends to use its series of proprietary lead compounds from its
novel macrolide library for uses such as the treatment of chronic inflammatory
diseases, endocrine diseases and gastric motility disorders. Additional
information about Cempra can be found at 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,
timing, regulatory review and results of our studies and clinical trials; our
anticipated capital expenditures and our estimates regarding our capital
requirements; our need to obtain additional funding and our ability to obtain
future funding on acceptable terms; our ability to obtain FDA approval of our
product candidates; our dependence on the success of solithromycin and Taksta;
the possible impairment of, or inability to obtain, intellectual property
rights and the costs of obtaining such rights from third parties; 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 realize for those
products; our ability to retain and hire necessary employees and to staff our
operations appropriately; our ability to compete in our industry; 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.



CEMPRA, INC.                                                                
SELECTED FINANCIAL INFORMATION                                              
                                                            
Condensed Consolidated Balance Sheets                                       
(in thousands)                                                              
                                                December 31, December 31,
                                                2013         2012
ASSETS                                                       
Current assets                                               
Cash and equivalents                             $ 96,503     $ 70,109
Receivables                                      1,626        --
Prepaid expenses                                 408          265
Total current assets                             98,537       70,374
Furniture, fixtures and equipment, net           138          43
Deposits                                         333          321
Total assets                                     $ 99,008     $ 70,738
                                                            
LIABILITIES                                                  
Current liabilities                                          
Accounts payable                                 $ 6,274      $ 2,172
Accrued expenses                                 392          342
Accrued payroll and benefits                     1,043        604
Deferred revenue                                 32           --
Warrant liability                                920          --
Current portion of long-term debt                2,201        2,227
                                                            
Total current liabilities                        10,862       5,345
Deferred revenue                                5,633        --
Long-term debt                                   12,538       7,623
Total liabilities                                $ 29,033     $ 12,968
Commitments and contingencies                    --           --
                                                            
                                                            
Shareholders' Equity                                        
Common stock; $.001 par value; 80,000,000 shares
authorized;24,903,774 and 33,186,656 issued and 33           25
outstanding at December 31, 2012 and December
31, 2013
                                                            
Addition paid-in capital                         236,202      178,971
                                                            
Deficit accumulated during the development stage (166,260)    (121,226)
Total shareholders' equity                      69,975       57,770
Total liabilities and shareholders' equity      $ 99,008     $ 70,738

                                                            
Condensed Consolidated Statements of Operations                             
(in thousands, except loss per share data)                                  
                                              Three Months Ended Dec. 31
                                              2013           2012
                                                            
Revenue                                                      
Contract research                             2,073          --
License                                       --            --
Total revenue                                $ 2,073        $--
Operating expenses                                           
Research and development                       15,683         4,413
General and administrative                     2,538          1,825
Total operating expenses                      18,221         6,238
Loss from operations                           (16,148)       (6,238)
                                                            
Other income (expense), net                    (682)          (330)
                                                            
Net loss and comprehensive loss                (16,830)       (6,568)
                                                            
Accretion of redeemable convertible preferred  --            --
shares
                                                            
Net loss attributable to common shareholders   $ (16,830)     $ (6,568)
                                                            
Basic and diluted net loss attributable to     $ (0.51)       $ (0.27)
common shareholders per share
                                                            
Basic and diluted weighted average shares      33,197         24,147
outstanding
                                                            
                                              Twelve Months Ended Dec. 31
                                              2013           2012
Revenue                                                      
Contract research                             3,478          --
License                                       4,335          --
Total revenue                                 $ 7,813        $--
Operating expenses                                           
Research and development                       41,300         16,869
General and administrative                     9,433          6,068
Total operating expenses                      50,733         22,937
Loss from operations                           (42,920)       (22,937)
                                                            
Other income (expense), net                    (2,115)        (1,289)
Net loss and comprehensive loss                (45,035)       (24,226)
                                                            
Accretion of redeemable convertible preferred  --            (314)
shares
                                                            
Net loss attributable to common shareholders   $ (45,035)     $ (24,540)
                                                            
Basic and diluted net loss attributable to     $ (1.53)       $ (1.23)
common shareholders per share
                                                            
Basic and diluted weighted average shares      29,450         19,883
outstanding

CONTACT: Investor and Media Contacts:
         Robert E. Flamm, Ph.D.
         Russo Partners, LLC
         (212) 845-4226
         Robert.flamm@russopartnersllc.com
        
         Andreas Marathovouniotis
         Russo Partners, LLC
         (212) 845-4235
         Andreas.marathis@russopartnersllc.com
 
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