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Cempra, Inc. Reports Second Quarter 2013 Financial and Operating Results

Cempra, Inc. Reports Second Quarter 2013 Financial and Operating Results

Company to Host Conference Call and Webcast at 4:30 p.m. EDT, Today, July 30,
2013

CHAPEL HILL, N.C., July 30, 2013 (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 second quarter
and six months ended June 30, 2013. The company will host a conference call
and webcast at 4:30 p.m. EDT, today.

"Cempra achieved several significant milestones during the second quarter of
2013 that, in particular, clarify the path toward approval for solithromycin,"
said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra. "Our
end-of-Phase 2 meeting with the FDA for solithromycin provided a very
satisfactory outcome so that we now understand the expected regulatory path to
an NDA submission for CABP. We are planning to initiate the IV-to-oral Phase 3
trial of solithromycin in CABP in the fourth quarter of 2013 based on that
meeting. We have raised the necessary capital estimated to fund our
solithromycin Phase 3 program in community-acquired bacterial infections, or
CABP, through a follow-on equity offering. The Biomedical Advanced Research
and Development Authority, or BARDA, is expected to fund the development of
solithromycin to treat infections in pediatric populations and infections by
bioterror threat pathogens. We are especially proud of our exclusive license
and development agreement for solithromycin in the Japanese market with Toyama
Chemical Co. Finally, we extended the potential exclusivity period for Taksta
to 2029 and we continue to look forward to disclosing interim top-line results
of the Taksta Phase 2 prosthetic joint infection, or PJI, study by the end of
the year. We look forward to an exciting second half of 2013 as we move closer
to bringing our differentiated antibiotics to market."

Financial Results

Quarter ended June 30, 2013 compared to quarter ended June 30, 2012

Net loss in the quarter ended June 30, 2013, was $4.2 million, or $0.16 per
share, compared to a net loss of $9.5 million, or $0.45 per share, for the
same period in 2012.

For the quarter ended June 30, 2013, Cempra reported total revenue of $4.6
million, compared to no revenue for the same quarter in 2012. The total
revenue in the second quarter 2013 was comprised of $4.3 million from a $10
million upfront payment from Toyama Chemical Co., Ltd, for exclusive license
and development agreement for solithromycin in Japan and $232 thousand from
the Biomedical Advanced Research and Development Authority (BARDA) for the
development of solithromycin to treat infections in pediatric populations and
for the treatment of infections by bio-terror threat pathogens. 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 will be recognized as solithromycin is launched.

Research and development expense in the quarter ended June 30, 2013, was $6.3
million, a decrease of 15% compared to the same quarter in 2012. The lower R&D
expense was primarily due to license and milestone payments to Scripps
Research Institute and Optimer Pharmaceuticals during the second quarter of
2012, which did not recur in 2013. General and administrative expense was $2.1
million, a 17% increase compared to the quarter ended June 30, 2012, driven
primarily by increased stock compensation expense, professional fees and
increased staffing.

Six months ended June 30, 2013 compared to six months ended June 30, 2012

For the six months ended June 30, 2013, Cempra reported a net loss of $14.6
million, or $0.57 per share, compared to a net loss of $13.0 million, or $0.76
per share, for the comparable period in the six months ended June 30, 2012.

Revenue was $4.6 million, compared to no revenue for the same period in 2012.

Research and development expense was $13.7 million, an increase of 47%
compared to the six months ended June 30, 2012. The increase was due to the
initiation of both the oral solithromycin Phase 3 clinical trial in CABP and
the Taksta Phase 2 clinical trial in PJI during the fourth quarter of 2012.
General & Administrative expense was $4.7 million, a 72% increase compared to
the six months ended June 30, 2012.

At June 30, 2013, Cempra had cash and equivalents of $121.6 million. The
increase compared to December 31, 2012 was primarily due to proceeds from the
public offering of common stock, the upfront payment from the signing of an
exclusive license and development agreement for solithromycin with Toyama
Chemical Co., Ltd. and a $5 million draw on a venture debt arrangement less
operating costs incurred in the first six months of the year.

Second Quarter 2013 Highlights

  *Completed a public offering of common stock and a partial exercise of the
    over-allotment option leading to net proceeds of approximately $54.2
    million
    
  *Awarded an up to $58 million contract to develop solithromycin for
    pediatric use and biodefense by the Biomedical Advanced Research and
    Development Authority (BARDA)
    
  *Signed an exclusive license and development agreement for solithromycin in
    Japan with Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings
    Corporation
    
  *Announced the results of an end-of-Phase 2 meeting on solithromycin with
    the FDA and provided guidance on the clinical program required for
    regulatory approval for solithromycin for CABP
    
  *Received patent allowance from the United States Patent and Trademark
    Office with claims directed to Cempra's novel loading dose regimen for
    Taksta™
    
  *Presented data at the American Thoracic Society International Conference
    (ATS 2013) demonstrating the antibacterial and enhanced immunomodulatory
    activity of solithromycin versus levofloxacin in Cempra's prior Phase 2
    clinical trial in outpatients with CABP
    
  *Presented data at the European Congress of Clinical Microbiology and
    Infectious Diseases (ECCMID) in Berlin, demonstrating solithromycin's
    potential to treat urogenital infections and combat challenging pathogens
    such as enterococci and Legionella pneumophila

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 in the second half of 2013:

Solithromycin

  *4Q13: Initiation of the IV-to-oral Phase 3 clinical trial in CABP

Taksta

  *4Q13: Interim top-line results of the Phase 2 trial in PJI patients

Financial Guidance

Cempra expects its research and development expense to increase due to the
initiation of clinical trials during the fourth quarter of 2012.The company's
cash and equivalents are expected to be sufficient to fund current operations
through 2015, including the Phase 3 IV-to-oral trial of solithromycin, which
is anticipated to be initiated in the fourth quarter of 2013.This projection
does not include any funds from additional sources such as a partnership or
the achievement of milestones under the Toyama Chemical agreement.

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., Second Quarter 2013
Financial Results Call, conference ID#: 16263207." 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
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; our
anticipated capital expenditures and our estimates regarding our capital
requirements; 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)                                                  
                                                   June 30,     December 31,
                                                   2013         2012
ASSETS                                              (unaudited) 
Current assets                                                  
Cash and equivalents                                $121,632  $70,109
Receivable                                          232          --
Prepaid expenses                                    513         265
Total current assets                                122,377 70,374
Furniture, fixtures and equipment, net              71          43
Deposits                                            322       321
Total assets                                        $122,770  $70,738
                                                               
LIABILITIES                                                     
Current liabilities                                             
Accounts payable                                    $1,974   $2,172
Accrued expenses                                    879         342
Accrued payroll and benefits                        466         604
Deferred revenue                                    23           --
Warrant liability                                   691          --
Current portion of long-term debt                   --        2,227
Total current liabilities                           4,033     5,345
Deferred revenue                                    5,642        --
Long-term debt                                      14,283      7,623
Total liabilities                                   $23,958    $12,968
Commitments and contingencies                                   
                                                               
                                                               
Shareholders' Equity                                            
Common stock; $.001 par value; 80,000,000 shares
authorized and 24,903,774 and 33,177,712 issued   33          25
and outstanding at December 31, 2012 and June 30,
2013
Addition paid-in capital                            234,562     178,971
                                                   (135,783)   (121,226)
Deficit accumulated during the development stage
Total shareholders' equity                         98,812      57,770
Total liabilities and shareholders' equity          $122,770   $70,738

                                              
                                              
                                              
Condensed Consolidated Statements of           
Operations
(unaudited; in thousands, except loss per      
share data)
                                              Three Months Ended June 30
                                              2013             2012
Revenues                                       $4,568    $--
Operating expenses                                             
Research and development                       6,327           7,424
General and administrative                     2,082      1,777
Total operating expenses                       8,409       9,201
Loss from operations                           (3,841) (9,201)
                                                              
Other income (expense), net                    (372)      (327)
                                                              
Net loss and comprehensive loss                (4,213)         (9,528)
                                                              
Accretion of redeemable convertible preferred  --      --
shares
                                                              
Net loss attributable to common shareholders   $(4,213)     $(9,528)
                                                              
Basic and diluted net loss attributable to     $(0.16)      $(0.45)
common shareholders per share
                                                              
Basic and diluted weighted average shares      26,382         21,035
outstanding
                                                              
                                                              
                                              Six Months Ended June 30
                                              2013             2012
Revenues                                       $4,568       $--
Costs and expenses                                             
Research and development                       13,698          9,300
General and administrative                     4,729          2,750
Total operating expenses                       18,427          12,050
Loss from operations                           (13,859)        (12,050)
                                                              
Other income (expense), net                    (699)           (628)
Net loss and comprehensive loss                (14,558)        (12,678)
                                                              
Accretion of redeemable convertible preferred  --            (313)
shares
                                                              
Net loss attributable to common shareholders   $(14,558)   $(12,991)
                                                              
Basic and diluted net loss attributable to     $(0.57)     $(0.76)
common shareholders per share
                                                              
Basic and diluted weighted average shares      25,647          17,143
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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