EMERYVILLE, CA, Nov. 15 /CNW/ - NovaBay Pharmaceuticals, Inc. (AMEX & TSX: NBY), a biopharmaceutical company focused on developing non-antibiotic anti-infective products targeting the treatment or prevention of a wide range of bacterial and viral infections, today reported results for the third quarter ended September 30, 2007.
Net loss for the quarter ended September 30, 2007 was $1.6 million, or $0.24 per share, as compared to a net loss of $1.5 million, or $0.24 per share, for the third quarter of 2006. For the nine months ended September 30, 2007, NovaBay reported a net loss of $4.0 million, or $0.62 per share, as compared to a net loss of $4.2 million, or $0.76 per share, for the nine months ended September 30, 2006.
As of September 30, 2007, NovaBay had $6.9 million in cash, cash equivalents and investments. At September 30, 2007, there were outstanding 6,632,170 shares of common stock and 19,227,195 shares of preferred stock (which were convertible into 9,613,554 shares of common stock).
Recent Developments and Corporate Highlights:
On October 31, 2007, NovaBay completed its initial public offering of
5,000,000 shares of common stock at a price to the public of
$4.00 per share, and received net proceeds of approximately
$17.2 million after deducting underwriting discounts and commissions
of $1.4 million and other offering costs of approximately
$1.4 million. The underwriters have an option to purchase an
additional 750,000 shares of common stock until 30 days after the
closing of the IPO. Upon the closing of the IPO, all shares of
convertible preferred stock outstanding automatically converted into
9,613,554 shares of common stock. As of the closing of the initial
public offering, the Company had 21,254,474 shares of common stock
outstanding and $24.2 million in cash, cash equivalents and
investments.
At the end of September 2007, NovaBay received clearance from the
U.S. Food and Drug Administration (FDA) for its NeutroPhase woundcare
product. NeutroPhase is NovaBay's proprietary solution of
hypochlorous acid, a molecule that is naturally produced by the
body's immune system to protect against pathogens. NeutroPhase has
been cleared by the FDA as a prescription product for moistening
absorbent wound dressings, irrigating and cleaning minor cuts, minor
burns, superficial abrasions and minor irritations of the skin, and
moistening, debriding and irrigating acute and chronic dermal
lesions, such as stage I-IV pressure ulcers, stasis ulcers, leg
ulcers, diabetic foot ulcers, post-surgical wounds, first and second
degree burns, and abrasions and minor irritations of the skin.
NeutroPhase has been licensed to an affiliate of Kinetic Concepts,
Inc. for development and commercialization purposes within the field
of wound healing.
At the end of September 2007, NovaBay completed the treatment phase
of the Phase I safety trial for NVC-422, NovaBay's lead compound in a
class of antimicrobial compounds that it calls the Aganocide
compounds, for the decolonization of the nasal passages prior to
surgery. A total of 96 subjects were enrolled in the trial. NVC-422
is being developed for use prior to surgery to kill pathogens in the
nasal passages, including Methicillin-Resistant Staphylococcus aureus
(MRSA). The presence of MRSA in the nasal passages has been
associated with a significant increase in the risk of surgical
infection and our development program is aimed at reducing this risk.
During the third quarter of 2007, NovaBay initiated toxicology
studies for NVC-422 for the prevention of catheter associated urinary
tract infections, a significant source of hospital-associated
infections. An Investigational New Drug application for this
indication is expected to be filed with the FDA before the end of
2007.
During the third quarter of 2007, NovaBay continued its work to
develop its Aganocide compounds with its partner, an affiliate of
Alcon, Inc., for use in the treatment of infections in the eye, ear
and sinus and in contact lens solutions.
About NovaBay
NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing innovative product candidates targeting the treatment or prevention of a wide range of infections in hospital and non-hospital environments. NovaBay has discovered and is developing a class of non-antibiotic anti-infective compounds, which it has named Aganocide compounds, which are based upon small molecules that are generated by white blood cells that defend the body against invading pathogens. NovaBay believes that Aganocide compounds could form a platform on which to create a variety of products to address differing needs in the treatment and prevention of bacterial and viral infections, including Methicillin-Resistant Staphylococcus aureus (MRSA). NovaBay has entered into a licensing and research collaboration agreement with an affiliate of Alcon, Inc. for use of the Aganocide compounds in the eye, ear and sinus and in contact lens solutions and a license agreement with an affiliate of Kinetic Concepts, Inc. for the use of NovaBay's NeutroPhase product in woundcare applications.
NovaBay(TM) , Aganocide(TM) and NeutroPhase(TM) are trademarks of NovaBay
Pharmaceuticals, Inc. All other trademarks and trade names are the
property of their respective owners.
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 development and potential benefits of, and the market opportunities for, NovaBay's product candidates. 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 discovery, development, testing, 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. 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.
NOVABAY PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2006 2007 2006 2007
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REVENUE
License and
collaboration
revenue $ 208 $ 1,444 $ 208 $ 4,392
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Total revenue 208 1,444 208 4,392
EXPENSES
Operating Expenses:
Research and
development 1,122 2,051 2,441 5,580
General and
administrative 634 1,021 2,065 3,125
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Total operating
expenses 1,756 3,072 4,506 8,705
Other income, net 58 72 97 307
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Net loss $ (1,490) $ (1,556) $ (4,201) $ (4,006)
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Basic and diluted
net loss per
share $ (0.24) $ (0.24) $ (0.76) $ (0.62)
Shares used to
compute basic and
diluted net loss
per share 6,234 6,564 5,524 6,494
NOVABAY PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
(in thousands)
December 31, September 30,
2006 2007
------------- -------------
(unaudited)
ASSETS
Current assets:
Cash, cash equivalents and investments $ 11,086 $ 6,881
Prepaid expenses and other current assets 226 364
------------- -------------
Total current assets 11,312 7,245
Property and equipment, net 554 912
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TOTAL ASSETS $ 11,866 $ 8,157
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LIABILITIES AND STOCKHOLDERS' EQUITY
Liabilities:
Current liabilities:
Accounts payable and accrued liabilities $ 886 $ 1,878
Deferred revenue 2,500 3,377
Other current liabilities - 170
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Total current liabilities 3,386 5,425
Deferred revenue - non-current 6,667 4,951
Other non-current liabilities - 373
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Total liabilities 10,053 10,749
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Stockholders' Equity (Deficit):
Convertible preferred stock 192 192
Common stock 63 66
Additional paid-in capital 14,620 14,207
Accumulated other comprehensive income 12 23
Accumulated deficit during development stage (13,074) (17,080)
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Total stockholders' equity (deficit) 1,813 (2,592)
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 11,866 $ 8,157
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