Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 10, 2012

 

 

CEMPRA, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-35405   26-264445

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

ID Number)

 

6340 Quadrangle Drive, Suite 200,

Chapel Hill, NC

  27517
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code (919) 313-6601

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On May 10, 2012, Cempra, Inc. issued a press release announcing its operating results for the first quarter ended March 31, 2012. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

99.1    Press release dated May 10, 2012.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    CEMPRA, INC.
Date: May 10, 2012  

/s/ Mark W. Hahn

  Mark W. Hahn, Chief Financial Officer
Press Release

Exhibit 99.1

FOR IMMEDIATE RELEASE

Cempra, Inc. Reports First Quarter 2012 Financial and Operating Results

- Company to Host Conference Call and Webcast at 4:30 p.m. EDT, May 10, 2012 -

CHAPEL HILL, N.C. – May 10, 2012 – 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, 2012. The company will host a conference call and webcast at 4:30 p.m. EDT, today.

“The first quarter of 2012 was a productive period for Cempra,” said Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra. “In February, we successfully completed our initial public offering, raising a net of $54.7 million including the exercise of over-allotment shares. At the end of the quarter, together with our collaborators, we presented several abstracts at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in London, including the full data set of our Phase 2 study comparing solithromycin with oral levofloxacin in patients with CABP. The study demonstrated that solithromycin’s efficacy was comparable to levofloxacin and that solithromycin had a favorable safety and tolerability profile compared to levofloxacin.”

Financial Results

For the first quarter ended March 31, 2012, Cempra reported a net loss of $3.5 million, or $0.26 per share, compared to a net loss of $6.2 million, or $12.16 per share, for the comparable period in the first quarter, 2011.

Research and development expense was $1.9 million, a decrease of 57% compared to the first quarter, 2011. The lower R&D expense was due to less clinical trial activity in the first quarter of 2012 compared to the first quarter of 2011. General & Administrative expense was $1.0 million, an 11% increase compared to the first quarter 2011, driven by stock compensation and professional service expenses.

At March 31, 2012, Cempra had cash and equivalents of $65.9 million. The increase compared to December 31, 2011 was due to proceeds obtained from the IPO less operational expenses that were incurred during the first quarter.

First Quarter 2012 Highlights

 

   

Completed the company’s initial public offering in February 2012 and raised a net of $54.7 million including the exercise of over-allotment shares


   

Presented several abstracts at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID):

 

   

Phase 2 study results demonstrated that solithromycin’s (CEM-101’s) efficacy was comparable to levofloxacin and solithromycin’s favorable safety and tolerability profile compared to levofloxacin

 

   

In vitro study showed that solithromycin was active against antibiotic-resistant strains of N. gonorrhoeae

 

   

In vitro study showed that solithromycin was more effective than azithromycin in penetrating Streptococcus pneumoniae biofilm

 

   

In vitro study further delineated the mechanism of action of telithromycin’s off-target activity on the nicotinic acetylcholine receptor

Clinical program update

As previously stated, 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, solithromycin, 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 and disclosure of top-line results by the end of the year

 

   

Receipt of a response from the Food and Drug Administration regarding plans for the oral pivotal Phase 3 protocol during the second quarter of 2012

 

   

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

 

   

Completion of the Phase 1 intravenous dosing clinical trial during the second half of 2012

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 fund operations into 2014. This projection does not include any proceeds from possible future partnerships


or other financing activities.

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 2012 Financial Results Call, conference ID#: 76657626.” 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 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 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

(unaudited; in thousands)

 

     March 31,
2012
    December 31,
2011
 

ASSETS

    

Current assets

    

Cash and equivalents

   $ 65,911      $ 15,602   

Prepaid expenses

     955        284   

Deferred offering expenses

     —          881   
  

 

 

   

 

 

 

Total current assets

     66,866        16,767   
  

 

 

   

 

 

 

Furniture, fixtures and equipment, net

     69        82   

Deposits

     10        10   
  

 

 

   

 

 

 

Total assets

   $ 66,945      $ 16,859   
  

 

 

   

 

 

 

LIABILITIES

    

Current liabilities

    

Accounts payable

   $ 2,650      $ 2,981   

Accrued expenses

     722        545   

Accrued payroll and benefits

     187        421   

Warrant liability

     —          1,121   
  

 

 

   

 

 

 

Total current liabilities

     3,559        5,068   
  

 

 

   

 

 

 

Convertible notes payable

     —          4,458   

Long-term debt

     9,589        9,504   
  

 

 

   

 

 

 

Total liabilities

   $ 13,148      $ 19,030   
  

 

 

   

 

 

 

Commitments and contingencies

     —          —     

Redeemable Convertible Preferred Shares

    

Redeemable convertible preferred shares

     —          94,514   

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 March 31, 2011

     —          —     

Common stock; $.001 par value; none issued and outstanding at December 31, 2011 and 80,000,000 shares authorized; 21,028,962 shares and outstanding at March 31, 2012

     21        —     

Addition paid-in capital

     153,924        —     

Accumulated deficit during the development stage

     (100,148     (96,685
  

 

 

   

 

 

 

Total shareholders’ deficit

     53,797        (96,685
  

 

 

   

 

 

 

Total liabilities, redeemable convertible preferred shares and shareholders’ deficit

   $ 66,945      $ 16,859   
  

 

 

   

 

 

 


Condensed Consolidated Statements of Operations

(unaudited; in thousands, except loss per share data)

 

     Three Months Ended
March 31
 
     2012     2011  

Revenues

   $ —        $ —     
  

 

 

   

 

 

 

Operating expenses

    

Research and development

     1,876        4,392   

General and administrative

     972        880   
  

 

 

   

 

 

 

Total operating expenses

     2,848        5,272   
  

 

 

   

 

 

 

Loss from operations

     (2,848     (5,272
  

 

 

   

 

 

 

Other income (expense), net

     (301     1   
  

 

 

   

 

 

 

Net loss

     (3,149     (5,271

Accretion of redeemable convertible preferred shares

     (314     (941
  

 

 

   

 

 

 

Net loss attributable to common shareholders

   $ (3,463   $ (6,212
  

 

 

   

 

 

 

Basic and diluted loss per share

   $ (0.26   $ (12.16
  

 

 

   

 

 

 

Basis and diluted weighted average shares outstanding

     13,250.5        510.7   
  

 

 

   

 

 

 

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