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NovaBay Pharmaceuticals Reports Fourth Quarter Financial Results And 2013 Clinical And Business Update

Stocks in this article: NBY

Aganocide® Compounds

NovaBay's first-in-class Aganocide compounds, led by NVC-422, are patented, topical antimicrobials with a broad spectrum of activity against bacteria, viruses and fungi. Mimicking the mechanism of action that human white blood cells use against infections, Aganocides are not subject to bacterial or fungal resistance, which has been demonstrated in in-vitro and in-vivo studies. Having demonstrated clinical efficacy in Phase 2 proof-of-concept clinical studies, NVC-422 is suited to treat and prevent a wide range of local, non-systemic infections. NovaBay's clinical development activities are focused on three disease areas:

  • Dermatology - Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo, which occurs most commonly in children. Clinical data results from the Phase 2b study are expected in the second half of 2013.
  • Ophthalmology - NovaBay is developing an eye drop formulation of NVC-422 for treating adenoviral conjunctivitis, a highly contagious viral eye infection for which there is no approved acute treatment. Enrollment into a global Phase 2b clinical study has begun, and clinical data results are expected in the second half of 2013.
  • Urology – NovaBay's urinary catheter irrigation solution containing NVC-422 is currently in a Phase 2b study, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. The company reported positive data from the Phase 2a study and is evaluating the effect of an alternate more potent formulation of NVC-422 in Phase 2b. Results are expected in the first half of 2013.

NeutroPhase ®

NeutroPhase is the only pure hypochlorous acid (HOCI) skin and wound cleanser cleared by the U.S. Food and Drug Administration (FDA) to target the six-million-patient U.S. market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers. The saline-based solution is the only wound cleanser on the market to include a stabilized, pure form of HOCl shown in studies to kill bacteria in solution, including flesh-eating bacteria. For additional information, visit: www.neutrophase.com .

Forward-Looking Statements

This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs.  These statements include, but are not limited to, statements regarding the expected timing of enrollment and commencement of clinical trials, expected timing of announcement of results of clinical studies, and expected future financial results.  The words "continued," "expected" and "will be" are intended to identify these forward-looking statements.  Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements.  Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in development, clinical trial, regulatory approval, production and marketing of the company's product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company's intellectual property or trade secrets, the company's ability to obtain additional financing as necessary and unanticipated research and development and other costs.  Other risks relating to NovaBay and Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay's latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading " Risk Factors ."  The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.

Stay informed on NovaBay's progress:

 
NOVABAY PHARMACEUTICALS, INC.
(a development stage company)
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
     
     
  December 31,
  2012 2011
     
ASSETS    
Current assets:    
Cash and cash equivalents  $ 12,735  $ 8,428
Short-term investments  4,135  5,710
Accounts receivable  943  3
Prepaid expenses and other current assets  445  417
Inventory  23  — 
Total current assets  18,281  14,558
Property and equipment, net  891  1,270
Other assets  63  135
TOTAL ASSETS  $ 19,235  $ 15,963
     
LIABILITIES AND STOCKHOLDERS' EQUITY  
Current liabilities:    
Accounts payable  $ 455  $ 472
Accrued liabilities  1,497  1,061
Deferred revenue  1,221  1,305
Total current liabilities  3,173  2,838
Deferred revenue - non-current  671  945
Deferred rent  60  115
Warrant liability  1,282  2,721
Total liabilities  5,186  6,619
     
     
Stockholders' Equity:    
Preferred stock, $0.01 par value; 5,000 shares authorized; none outstanding at December 31, 2012 and 2011  —   — 
Common stock, $0.01 par value; 65,000 shares authorized;36,915 and 28,587 shares issued and outstanding at December 31, 2012 and 2011, respectively  369  286
Additional paid-in capital  54,004  42,386
Accumulated other comprehensive loss  (13)  (44)
Accumulated deficit during development stage  (40,311)  (33,284)
 Total stockholders' equity  14,049  9,344
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY  $ 19,235  $ 15,963
 
 
NOVABAY PHARMACEUTICALS, INC.
(A development stage company)
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
       
      Cumulative Period
       from July 1, 2002
       (inception) to
  Year Ended December 31,  December 31,
  2012 2011 2012
Revenue:      
License, collaboration and distribution revenue  $ 6,855  $ 10,993  $ 57,454
Other revenues  92  26  118
Total revenue  6,947  11,019  57,572
       
Operating expenses:      
Research and development  9,275  9,911  60,146
Selling, general and administrative  5,981  5,429  39,635
Total operating expenses  15,256  15,340  99,781
Operating loss  (8,309)  (4,321)  (42,209)
       
Non-cash gain on change in fair value of warrants  1,439  (732)  707
Other income (expense), net  (155)  (30)  1,266
       
Loss before income taxes  (7,025)  (5,083)  (40,236)
Provision for income taxes  (2)  (2)  (75)
Net loss  (7,027)  (5,085)  (40,311)
       
Other comprehensive gain (loss):      
Change in unrealized gains (losses) on available-for-sale securities  31  (30)  (13)
Total comprehensive income (loss)  $ (6,996)  $ (5,115)  $ (40,324)
       
Net loss per share:      
Basic and diluted  $ (0.24)  $ (0.20)  
Shares used in per share calculations:      
Basic and diluted  29,448  25,773  
CONTACT: Investors:
         NovaBay Pharmaceuticals, Inc.
         Thomas J. Paulson
         Chief Financial Officer
         510-899-8809
         tjpaulson@novabaypharma.com
         
         Investors and Media:
         The Ruth Group
         Stephanie Carrington / Nicole Greenbaum (Investors)
         (646) 536-7017 / 7009
         scarrington@theruthgroup.com / ngreenbaum@theruthgroup.com
         
         Aaron Estrada (Media)
         (646) 536-7028
         aestrada@theruthgroup.com

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