-- Expanded and strengthened management team with the appointment of Roy
Wu, as senior vice president of business development, and Mark Anderson,
Ph.D., as chief scientific officer. Bez Khosrovi also assumed an expanded
role as senior vice president for product development and chief alliance
officer
-- Partner Alcon initiated a Phase 2 clinical trial of lead Aganocide
compound NVC-422 for the treatment of viral conjunctivitis
-- Launched a Phase 2a proof-of-concept study of NVC-422 for the
treatment of impetigo, one of the most common skin infections, with partner
Galderma, S.A., the world's leading dermatology company
-- Presented positive data from two pre-clinical studies of NVC-422 at
the 49th Annual Interscience Conference on Antimicrobial Agents and
Chemotherapy conference, revealing that NVC-422 had potent activity in
killing bacteria that have developed resistance to antiseptics and
antibiotics
-- Presented data at the 47th Annual Meeting of the Infectious Diseases
Society of America (IDSA) showing that NovaBay's Aganocide compounds
demonstrated efficacy and penetration in an established pre-clinical
infected nail model of onychomycosis, or nail fungus
-- Recognized as a New California 100 Innovative Business by Golden
Capital Network and Hamilton Lane
Pipeline Overview
NovaBay also provided the following detailed pipeline overview of its most
advanced partnered and proprietary development programs:
-- NovaBay and Alcon are currently conducting a Phase 2 clinical trial
for the treatment of viral conjunctivitis, or "pink eye," at 30 centers
around the U.S. in approximately 250 patients. The trial is expected to
conclude in early 2010, with top-line data available in the first half of
2010. NovaBay and its partner Alcon anticipate presenting complete Phase 2
data at an appropriate medical meeting later in 2010. Conjunctivitis
represents a potential $500 million to $1 billion market. While there are
several antibiotics to treat the bacterial form of conjunctivitis, there
are currently no medications to treat viral conjunctivitis. NovaBay's
current formulation under development will have the potential to treat both
bacterial and viral conjunctivitis. As part of the original NovaBay and
Alcon collaboration, Alcon has paid NovaBay a $10 million upfront licensing
fee and NovaBay may receive up to an additional $70 million in clinical
milestones plus $20 million to support ongoing research and development
efforts.
-- NovaBay and partner Galderma S.A. are conducting a Phase 2 clinical
trial of NVC-422 in impetigo, a common skin condition that primarily
affects children between the ages of 2 and 12. More than 1 million cases of
impetigo are diagnosed annually in the United States alone. Top-line data
is expected in the first half of 2010. As part of the NovaBay and Galderma
collaboration signed in March 2009, NovaBay received a $2 million upfront
payment. The company may receive up to $50 million in clinical milestones
and R&D reimbursements.
-- NovaBay has initiated a Phase 2 trial of NVC-422 for the treatment of
catheter-associated urinary tract infection (CAUTI). During the Phase 2
trial, chronically catheterized patients with confirmed cases of
bacteriuria receive a daily irrigation of bladder lavage to measure the
extent to which NVC-422 can reduce the bacterial load, and therefore the
incidence of CAUTI. CAUTI is the most common nosocomial (hospital-acquired)
infection, responsible for nearly 40% of infections related to
hospitalization. Top-line data from this trial is expected in the first
half of 2010. A Phase 1 trial showed that NVC-422 was safe in healthy
volunteers. In multiple pre-clinical studies, with Foley catheters, NVC-422
solution demonstrated the ability to penetrate and eliminate the bacteria
residing in biofilm. This is of particular importance in CAUTI, as biofilms
-- - which are complex colonies of microorganisms, proteins and other
components -- form readily around catheters and often develop broad
resistance to many commonly used antibiotics.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on developing its proprietary and patented Aganocide® compounds
as first-in-class, novel, synthetic anti-infective product candidates that
are bioequivalent to the active antimicrobial molecules generated within
white blood cells to treat and prevent a wide range of infections without
causing resistance.
NovaBay has internal development programs aimed at addressing hospital and
respiratory infections. The company has a licensing and research
collaboration agreement with Alcon, Inc. for use of its Aganocides in the
eye, ear and sinus, and in contact lens solutions. NovaBay has entered into
an agreement with Galderma S.A. to develop and commercialize Aganocides in
acne, impetigo and other dermatological indications. NovaBay™ and
Aganocide® are trademarks of NovaBay Pharmaceuticals, Inc. For more
information on NovaBay, visit www.novabaypharma.com.
Forward-Looking Statements
This release contains forward-looking statements, which are based upon
NovaBay's current expectations, assumptions, estimates, projections and
beliefs. Statements regarding NovaBay's expectations that it will receive
from Alcon up to $70 million in clinical milestones plus $20 million to
support ongoing research and development efforts, and that it will receive
from Galderma up to $50 million upon achievement of certain development and
regulatory milestones, NovaBay's expectations regarding its clinical
programs, including the timing of conclusions of those trials and when it
will receive clinical data, as well as other statements that relate to
future events or results, are 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: the risk that milestones and net sales may
not be achieved under the Alcon and Galderma agreements; risks and
uncertainties relating to difficulties or delays in discovery, development,
testing, 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; results obtained in animal models may
not be obtained in humans; and the risk of unexpected delays in the
regulatory process which may delay the commencement or completion of
clinical trials. Other risks relating to NovaBay and Aganocide®
compounds, including risks that could cause actual results to differ
materially from those projected in the forward-looking statements in this
press release, are detailed in NovaBay's Quarterly Report on Form 10-Q for
the period ended September 30, 2009, under the caption "Risk Factors" in
Item 1A of Part I of that report, filed with the Securities and Exchange
Commission on November 12, 2009. 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.
Cumulative
Period from
July 1, 2002
(date of
development
stage
Three Months Ended Nine Months Ended inception) to
September 30, September 30, September 30,
---------------------- ---------------------- ------------
2008 2009 2008 2009 2009
---------- ---------- ---------- ---------- ------------
(unaudited) (unaudited) (unaudited) (unaudited) (unaudited)
REVENUE
License and
collaboration
revenue $ 1,592 $ 3,224 $ 4,526 $ 8,192 $ 22,360
EXPENSES
Operating
Expenses:
Research and
development 1,614 2,004 6,861 4,809 29,816
General and
administra-
tive 1,544 1,309 4,575 4,078 21,043
---------- ---------- ---------- ---------- -----------
Total
operating
expenses 3,158 3,313 11,436 8,887 50,859
Interest
expense (28) (56) (77) (98) (244)
Other income
(expense),
net 105 34 411 75 1,450
---------- ---------- ---------- ---------- -----------
Total Other
income
(expense), net 77 (22) 334 (23) 1,206
Net loss
before income
taxes (1,489) (111) (6,576) (718) (27,293)
Provision for
income taxes - 2 14
---------- ---------- ---------- ---------- -----------
Net loss $ (1,489) $ (111) $ (6,578) $ (718) $ (27,307)
========== ========== ========== ========== ===========
Net loss per
share:
Basic and
diluted $ (0.07) $ (0.00) $ (0.31) $ (0.03)
Shares used in
per share
calculations:
Basic and
diluted 21,443 23,251 21,313 22,117
Contact Information: Contact: NovaBay Pharmaceuticals, Inc. Tom Paulson 510-899-8809 Chief Financial Officer tpaulson@novabaypharma.com Media Relations: Aimee Corso 503-855-4502 acorso@wcpglobal.com