Cempra, Inc. Reports Fourth Quarter and Full Year 2012 Financial and Operating Results

Cempra, Inc. Reports Fourth Quarter and Full Year 2012 Financial and Operating
                                   Results

- Company to Host Conference Call and Webcast at 4:30 p.m. EST, Today, Feb.
28, 2013 -

PR Newswire

CHAPEL HILL, N.C., Feb. 28, 2013

CHAPEL HILL, N.C., Feb. 28, 2013 /PRNewswire/ --Cempra, Inc. (Nasdaq: CEMP),
a clinical-stage pharmaceutical company focused on developing differentiated
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, 2012. The company will host a conference call and
webcast at 4:30 p.m. EST, today.

"2012 was a transformational year for Cempra," said Prabhavathi Fernandes,
Ph.D., chief executive officer of Cempra. "We raised sufficient capital
through our IPO and a subsequent private placement to advance our two
differentiated antibiotics in clinical development. Solithromycin is now in
the first of two planned Phase 3 clinical trials in community-acquired
bacterial pneumonia or CABP and Taksta (CEM-102) is undergoing a Phase 2 trial
in patients with prosthetic joint infections or PJIs. 2013 will also be an
important year as we expect to hold an end-of-Phase 2 meeting with the FDA
during the first half of 2013 for solithromycin in CABP as the key step in
preparing for the IV-to-oral second Phase 3 trial, which we expect to start in
the second half of 2013 subject to available resources. We also anticipate
presenting some top-line results for the TAKSTA™ Phase 2 trial in PJIs in the
fourth quarter of 2013."

Financial Results

Quarter ended December 31, 2012 compared to quarter ended December 31, 2011

For the quarter ended December 31, 2012, Cempra reported a net loss of $6.6
million, or $0.26 per share, compared to a net loss of $3.8 million, or $7.13
per share, for the same period in 2011.

Research and development expense in the quarter ended December 31, 2012, was
$4.4 million, a 203% increase compared to the fourth quarter of 2011. The
increased R&D expense was primarily due to increases in clinical activity in
the Phase 3 oral, Phase 2 urethritis and Phase 1 intravenous clinical programs
for solithromycin. General and administrative expense was $1.8 million, a 73%
increase compared to the quarter ended December 31, 2011, driven primarily by
increased employee and legal expenses.

Year ended December 31, 2012 compared to the year ended December 31, 2011

For the year ended December 31, 2012, Cempra reported a net loss of $24.5
million, or $1.23 per share, compared to a net loss of $25.0 million, or
$47.53 per share, for the year ended 2011.

Research and development expense was $16.9 million, consistent with the $16.9
million of R&D spend for 2011. General and administrative expense was $6.1
million, a 64% increase over the $3.7 million for the year ended 2011.

At December 31, 2012, Cempra had cash and equivalents of $70.1 million. The
increase compared to December 31, 2011 was due to proceeds obtained from the
IPO in February 2012 and from the private placement in October 2012 less
operational expenses that were incurred during 2012.

Fourth Quarter 2012 Highlights

  oReleased top-line results of the solithromycin Phase 2 trial in patients
    with uncomplicated urogenital gonococcal infections early in the fourth
    quarter of 2012; all 22 then evaluable patients were cleared of their
    gonococcal infections at all infected body sites with a single dose of
    solithromycin
  oAnnounced results from the Phase 1 intravenous (IV) dosing clinical trial
    early in the fourth quarter of 2012 and indicated that 400 mg once-daily
    would be used in the IV-to-oral Phase 3 study
  oRaised approximately $25 million in a private placement for which proceeds
    are to be used for general corporate and working capital purposes
    including the funding of clinical trials
  oInitiated the TAKSTA Phase 2 clinical trial in patients with prosthetic
    joint infections (PJIs)
  oInitiated the oral solithromycin Phase 3 clinical trial in patients with
    community-acquired bacterial pneumonia

Clinical program update

The company is primarily focused on the development of its two lead
clinical-stage antibiotic candidates, the fluoroketolide, solithromycin, in
clinical development for CABP and uncomplicated gonococcal infections and
TAKSTA, the oral antibiotic being developed for prosthetic joint infections.
The company expects the following events to occur during 2013:

Solithromycin

  o1H13: 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

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 the solithromycin Phase 3 and the TAKSTA Phase 2 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 initiation of the planned IV-to-oral solithromycin
Phase 3 trial.

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., Full year 2012
Financial Results Call, conference ID#: 12497222." 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 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
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)
                                       December 31,          December 31,
                                       2012                  2011
ASSETS
Current assets
  Cash and equivalents                 $       70,109  $      
                                                             15,602
  Prepaid expenses                     265                   284
  Deferred offering expenses           -                     881
Total current assets                   70,374                16,767
Furniture, fixtures and equipment, net 43                    82
Deposits                               321                   10
Total assets                           $       70,738  $      
                                                             16,859
LIABILITIES
Current liabilities
  Accounts payable                     $              $       
                                       2,172                 2,981
  Accrued expenses                     342                   545
  Accrued payroll and benefits         604                   421
  Warrant liability                    -                     1,121
  Current portion of long-term debt    2,227                 -
   Total current liabilities  5,345                 5,068
Convertible notes payable              -                     4,458
Long-term debt                         7,623                 9,504
Total liabilities                      $      12,968   $     
                                                             19,030
Commitments and Contingencies
Redeemable Convertible Preferred       -                     94,514
Shares
Shareholders' Equity (Deficit)
Common shares; 100,000,000 shares
authorized, no par value;
533,839 shares issued and outstanding
at December 31, 2011 and
none issued and outstanding at         -                     -
December 31, 2012
Common stock; $.001 par value; none
issued and outstanding at
December 31, 2011 and 80,000,000
shares authorized; 24,903,774
shares issued and outstanding at       25                    -
December 31, 2012
Additional paid-in capital             178,971               -
Deficit accumulated during the         (121,226)             (96,685)
development stage
  Total shareholders' equity           57,770                (96,685)
  (deficit)
  Total liabilities, redeemable
  convertible preferred shares
  and shareholders' equity (deficit)   $       70,738  $     16,859

Condensed Consolidated Statements of Operations
(unaudited; in thousands, except loss per share data)
                                               Three Months Ended December 31,
                                               2012             2011
                                               
Revenues                                                        $ -
                                               $ -
Operating expenses
          Research and development             4,413            1,458
          General and administrative           1,825            1,057
          Total costs and expenses             6,238            2,515
Loss from operations                           (6,238)          (2,515)
Other income (expense), net                    (330)            (352)
Net loss and comprehensive loss                (6,568)          (2,867)
Accretion of redeemable convertible preferred  -                941
shares
Net loss attributable to common shareholders   $ (6,568)        $ (3,808)
Basic and diluted loss per share               $ 0.26)          $ (7.13)
Basic and diluted weighted average shares      24,904           534
outstanding

                                                 Full Year Ended December 31,
                                                 2012         2011
Revenues                                  $           $       
                                             -                -
Operating expenses
 Research and development        16,869              16,872
General and administrative      6,068               3,708
 Total costs and       22,937              20,580
expenses
Loss from operations                      (22,937)            (20,580)
Other income (expense), net               (1,289)             (641)
Net loss and comprehensive loss           (24,226)            (21,221)
Accretion of redeemable convertible       (314)               (3,763)
preferred shares
Net loss attributable to common           $               $     
shareholders                              (24,540)           (24,984)
Basic and diluted loss per share          $             $      
                                          (1.23)             (47.53)
Basic and diluted weighted average shares 19,883              525.7
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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