2014

Cempra, Inc. Reports Full Year 2011 Financial Results

CHAPEL HILL, N.C., March 30, 2012 /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 full year ended December 31, 2011.

"2011 was an eventful year for Cempra," said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra.  "Both of our differentiated antibiotic candidates made progress in the clinic.  For CEM-101, we announced positive top-line results in a Phase 2 clinical trial in community-acquired bacterial pneumonia (CABP) patients compared to levofloxacin.  In 2012, we secured funding through an initial public offering to allow us to move both candidates forward in clinical development: CEM-101 in CABP and Taksta™ in prosthetic joint infections.  Fusidic acid, the active agent in Taksta, has been used successfully to treat these chronic infections in Australia and Switzerland.  Additionally, Taksta has demonstrated activity against methicillin-resistant Staphylococcus aureus (MRSA) strains isolated from cystic fibrosis patients, indicating a possible additional chronic use."

Financial Results

For the year ended December 31, 2011, Cempra reported a net loss of $25.0 million, or $47.53 per share, compared to a net loss of $22.9 million, or $46.60 per share, for the comparable period in 2010.  The increase in net loss per share was primarily due to increased research and development expense related to the company's Phase 2 trial of CEM-101 in CABP.

At December 31, 2011, Cempra had cash and equivalents of $15.6 million.  This number does not include net proceeds of $54.7 million, including the overallotment option, raised in an initial public offering that closed in February 2012. The company also drew $10 million on a $20 million venture debt facility in December 2011, the proceeds of which are included in cash and equivalents at December 31, 2011.

2011 Highlights

  • Oral CEM-101 (solithromycin) demonstrated efficacy comparable to levofloxacin and showed a favorable safety and tolerability profile in a Phase 2 trial in patients with CABP
  • Intravenous CEM-101 was systemically well tolerated and showed favorable pharmacokinetics in single doses up to 1,000 mg when given intravenously, achieving clinically relevant plasma concentrations
  • Published research showing that fusidic acid (Taksta) was active against MRSA strains isolated from cystic fibrosis patients
  • Filed a registration statement for an initial public offering of Cempra stock, which closed in February 2012, raising net proceeds of $54.7 million, including the overallotment option.

Clinical program update

The proceeds of the company's initial public offering will be directed primarily to the company's two lead clinical-stage antibiotic candidates, the fluoroketolide, CEM-101, and the anti-Staphylococcus aureus compound, Taksta™.  The company expects the following events to occur during 2012.

CEM-101

  • Initiation of the urethritis Phase 2 trial during the second quarter of 2012

  • Initiation of the oral Phase 3 trial during the second half of 2012

  • Completion of the Phase 1 IV clinical trial during the second half of 2012

  • Finalize the oral pivotal phase 3 protocol with the FDA during the second quarter of 2012

  • Three abstracts to be presented at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), March 31 to April 3

Taksta

  • Initiation of the Phase 2 trial in prosthetic joint infection (PJI) patients during the fourth quarter of 2012

Financial Guidance

Cempra expects its research and development expense to increase due to the initiation of several clinical trials in 2012.  The company's cash and equivalents are expected to be sufficient to continue operations into 2014.  This projection does not include the proceeds from any possible partnerships.

"Cempra is well positioned to have a very productive 2012," said Dr. Fernandes.  "We now have the capital to initiate our CEM-101 oral phase 3 trial in CABP and our Taksta Phase 2 trial in PJI.  We are also planning to start a Phase 2 trial with oral solithromycin on urethritis patients.  The problem of drug-resistant gonococci has been growing in the U.S. and new treatment options are needed.  We are continuing our discussions to partner the solithromycin development program.  We look forward to keeping our investors updated on activities at the company through 2012."

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 have both completed oral Phase 2 clinical trials and 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 CEM-101 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 CEM-101 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,



2011

2010

ASSETS



Current assets




Cash and equivalents

$             15,602

$             20,048


Prepaid expenses

284

288


Deferred offering expenses

881

-

Total current assets

16,767

20,336

Furniture, fixtures and equipment, net

82

144

Deposits

10

53

Total assets

$             16,859

$             20,533





LIABILITIES



Current liabilities




Accounts payable

$              2,981

$              1,546


Accrued expenses

545

132


Accrued payroll and benefits

421

319


Warrant liability

1,121

-


         Total current liabilities

5,068

1,997

Convertible notes payable

4,458

-

Long-term debt

9,504

-

Total liabilities

$             19,030

$              1,997

Commitments and contingencies

-

-





Redeemable Convertible Preferred Shares



Redeemable convertible preferred shares

94,514

90,751





Shareholders' Equity (Deficit)



Common shares: 100,000,000 shares authorized, no par value;



495,024 shares issued and outstanding at December 31, 2010 and



533,839 shares issued and outstanding at December 31, 2011

-

-

Addition paid-in capital

-

-

Deficit accumulated during the development stage

(96,685)

(72,215)


Total shareholders' deficit

(96,685)

(72,215)


Total liabilities, redeemable convertible preferred shares




and shareholders' deficit

$             16,859

$             20,533





Condensed Consolidated Statements of Operations

(in thousands, except loss per share data)



Twelve Months Ended



December 31



2011

2010

Revenues

$                    -

$                       -

Operating expenses




Research and development

16,872

15,475


General and administrative

3,708

3,198


         Total operating expenses

20,580

18,673

Loss from operations

(20,580)

(18,673)





Other income (expense), net

(641)

(1,002)





Net loss

(21,221)

(19,675)





Accretion of redeemable convertible preferred shares

(3,763)

(3,238)





Net loss attributable to common shareholders

$            (24,984)

$          (22,913)





Basic and diluted loss per share

$              (47.53)

$            (46.60)





Basis and diluted weighted average shares outstanding

525.7

491.7




Investor 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

Media Contact:
Elliot Fox
Russo Partners, LLC
(212) 845-4253
Elliot.fox@russopartnersllc.com

SOURCE Cempra, Inc.



RELATED LINKS
http://www.cempra.com

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