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."
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.
- 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.
- 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
- Initiation of the Phase 2 trial in prosthetic joint infection (PJI) patients during the fourth quarter of 2012
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
Cash and equivalents
Deferred offering expenses
Total current assets
Furniture, fixtures and equipment, net
Accrued payroll and benefits
Total current liabilities
Convertible notes payable
Commitments and contingencies
Redeemable Convertible Preferred Shares
Redeemable convertible preferred shares
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
Total shareholders' deficit
Total liabilities, redeemable convertible preferred shares
and shareholders' deficit
Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
Twelve Months Ended
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense), net
Accretion of redeemable convertible preferred shares
Net loss attributable to common shareholders
Basic and diluted loss per share
Basis and diluted weighted average shares outstanding
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SOURCE Cempra, Inc.