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

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

- Company to Host Conference Call and Webcast at 4:30 p.m. EDT, Today, Apr.
25, 2013 -

PR Newswire

CHAPEL HILL, N.C., April 25, 2013

CHAPEL HILL, N.C., April 25, 2013 /PRNewswire/ --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 first quarter ended March 31, 2013.
The company will host a conference call and webcast at 4:30 p.m. EDT, today.

"The first quarter of 2013 was an important one for Cempra as we continued our
oral solithromycin Phase 3 clinical trial in patients with community-acquired
bacterial pneumonia and our Taksta Phase 2 trial in patients with prosthetic
joint infections," said Prabhavathi Fernandes, Ph.D., chief executive officer
of Cempra. "Looking ahead, we continue to prepare to initiate the
solithromycin intravenous-to-oral Phase 3 trial in community-acquired
bacterial pneumonia, or CABP, pending available resources, and to plan
meetings with the FDA on the solithromycin IV-to-oral Phase 3 trial in the
second quarter and the Taksta prosthetic joint infection program later this
year."

Financial Results

Quarter ended March 31, 2013 compared to quarter ended March 31, 2012

For the quarter ended March 31, 2013, Cempra reported a net loss of $10.3
million, or $0.42 per share, compared to a net loss of $3.5 million, or $0.26
per share, for the same period in 2012.

Research and development expense in the quarter ended March 31, 2013, was $7.4
million, an increase of 293% compared to the same quarter in 2012. The higher
R&D expense was primarily due to the initiation of the oral solithromycin
Phase 3 clinical trial in patients with community-acquired bacterial pnuemonia
and the initiation of the Taksta™ Phase 2 clinical trial in patients with
prosthetic joint infections; both of which were initiated during the fourth
quarter of 2012. General and administrative expense was $2.7 million, a 172%
increase compared to the quarter ended March 31, 2012, driven primarily by
increased stock compensation expense and professional fees. 

First Quarter and early second quarter 2013 Highlights

  oFiled an S-3 shelf registration statement with the Securities and Exchange
    Commission
  oSubmitted our request for an end-of-phase 2 meeting on solithromycin to
    the FDA

Clinical program update

The company is primarily 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 during 2013:

Solithromycin

  o2Q13: End of Phase 2 meeting with the FDA
  o2H13: Initiation of the IV-to-oral Phase 3 clinical trial in CABP, subject
    to available resources
  o2Q13: Present the ongoing Phase 2 gonococcus clinical study at ECCMID

Taksta

  o4Q13: 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 into 2015. This projection does not include any funds for the
initiation of the solithromycin IV-to-oral Phase 3 clinical trial in CABP.

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., First Quarter 2013
Financial Results Call, conference ID#: 33311244." 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 in advanced clinical development; solithromycin in Phase 3 for
CABP and TAKSTA™ (CEM-102) in Phase 2 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
utilize 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)
                                                      March 31,   December 31,
                                                      2013        2012
ASSETS                                                (unaudited)
Current assets
         Cash and equivalents                         $ 60,152    $ 70,109
         Prepaid expenses                             644         265
Total current assets                                  60,796      70,374
Furniture, fixtures and equipment, net                56          43
Deposits                                              321         321
Total assets                                          $ 61,173    $ 70,738
LIABILITIES
Current liabilities
         Accounts payable                             $ 1,608     $ 2,172
         Accrued expenses                             999         342
         Accrued payroll and benefits                 212         604
         Current portion of long-term debt            3,008       2,227
          Total current liabilities                5,827       5,345
Long-term debt                                        6,930       7,623
Total liabilities                                     $ 12,757    $ 12,968
Commitments and contingencies
Shareholders' Equity
Common stock; $.001 par value; 80,000,000 shares
authorized and 24,903,774 shares issued and           25          25
outstanding at December 31, 2012 and March 31, 2013
Addition paid-in capital                              179,961     178,971
Accumulated deficit during the development stage      (131,570)   (121,226)
         Total shareholders' equity                   48,416      57,770
         Total liabilities and shareholders' equity   $ 61,173    $ 70,738

Condensed Consolidated Statements of Operations
(unaudited; in thousands, except loss per share data)
                                                   Three Months Ended March 31
                                                   2013          2012
Revenues                                           $ -           $ -
Operating expenses
             Research and development              7,371         1,876
             General and administrative            2,647         972
              Total operating expenses          10,018        2,848
Loss from operations                               (10,018)      (2,848)
Other income (expense), net                        (327)         (301)
Net loss and comprehensive loss                    (10,345)      (3,149)
Accretion of redeemable convertible preferred      -             (314)
shares
Net loss attributable to common shareholders       $ (10,345)    $ (3,463)
Basic and diluted loss per share                   $ (0.42)      $ (0.26)
Basic and diluted weighted average shares          24,904        13,251
outstanding

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







SOURCE Cempra, Inc.

Website: http://www.cempra.com
 
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