Programs in Dermatology, Urology, Ophthalmology and Wound Care Advancing
EMERYVILLE, Calif., Nov. 7, 2011 (GLOBE NEWSWIRE) -- NovaBay® Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical-stage biotechnology company developing its first-in-class, anti-infective Aganocide® compounds for the local non-systemic treatment and prevention of antibiotic-resistant infections, has reported its third quarter 2011 financial results and recent progress in its in-house and partnered programs.
As of September 30, 2011, the company's cash, cash equivalents and short-term investments totaled $14.7 million. However, cash, cash equivalents, short-term investments and accounts receivable totaled $16.5 million. This number reflects receipt of the net proceeds from the company's July financing of $4.7 million, the receipt of all outstanding funds from Alcon during Q3 and accounts receivable from Galderma as of September 30, 2011 related to reimbursement of NovaBay's clinical trials.
NovaBay reported a third quarter net income of $106,000, or $0.00 per share, compared with a net loss of $1.6 million or $0.07 per share for the quarter ended September 30, 2010. The net income was due to non-cash gains on the warrants issued as part of the company's July 2011 financing. NovaBay's operating loss for the third quarter was $348,000 compared with $1.6 million for the quarter ended September 30, 2010. The significant decrease in NovaBay's operating loss was a result of increased revenues related to the company's collaboration with Galderma and a concerted effort to reduce NovaBay's general and administrative costs.
The company's research and development and clinical expenses were $2.0 million in the third quarter of 2011, compared with $2.2 million in the third quarter of 2010, reflecting Galderma's assumption of many of the costs related to NovaBay's impetigo trials, offset by continued investments in urinary catheter blockage and encrustation (UCBE) clinical trials and production for NovaBay's NeutroPhase® product that is scheduled to be available for sale in 2012.
During the third quarter, NovaBay continued to advance three Phase 2 clinical trial programs:
1) NovaBay's partner, Galderma, S.A., is finalizing preparation to launch a Phase 2b clinical study for the treatment of impetigo during the fourth quarter, with data expected in the second half of 2012;
2) Part one of the UCBE, Phase 2 trial is now complete and enrollment for part two is underway. Preliminary results of part one are expected in the first quarter of 2012 with final results on part two expected to be available in the first half of 2012; and
3) NovaBay is moving forward with the development of Aganocides for conjunctivitis (pink eye) on its own and will aim to re-partner this program after completion of this Phase 2b trial. The company is planning to commence the conjunctivitis Ph2b trial in Q1 2012. During the third quarter, NovaBay brought on board former Alcon executive Dr. David W. Stroman to lead this program.
NovaBay also reported that its FDA 510(k)-cleared NeutroPhase product for wound care is in manufacturing scale-up and is expected to be available for commercial launch during the first half of 2012 to the approximately six million patients in the U.S. suffering from chronic, non-healing wounds such as diabetic, pressure, and venous stasis ulcers. NovaBay presented NeutroPhase at a breakfast symposium at the Symposium on Advanced Wound Care (SAWC) on October 15 to highlight the value of NeutroPhase for Wound Care in accelerating the healing of chronic non-healing wounds. NovaBay does not expect to directly market NeutroPhase, but is seeking an appropriate commercial partner in the U.S.
Third Quarter and Recent Highlights:
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October 14, 2011 - NovaBay Pharmaceuticals Spotlights NeutroPhase at the Symposium on Advanced Wound Care (SAWC): NeutroPhase is a FDA 510(k)-cleared advanced wound care product addressing the unmet medical needs of the six-million-patient U.S. chronic wound care market. This was the first introduction of NeutroPhase at the Symposium on Advanced Wound Care (SAWC) in Las Vegas, Nevada.
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October 4, 2011 - NovaBay Pharmaceuticals Names David W. Stroman, Ph.D. As Head of Ophthalmic Drug Development: Dr. Stroman comes to NovaBay Pharmaceuticals with over four decades of experience in the medical products industry. Prior to his arrival at NovaBay, he worked for 21 years at Alcon, most recently as Therapeutic Unit Head for Anti-Infectives.
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September 28, 2011 - NovaBay Pharmaceuticals Names Russell A. Hoon As Vice President of its Advanced Wound Care Business Unit: Mr. Hoon comes to NovaBay Pharmaceuticals with more than three decades of experience in medical product development, sales, marketing and management.
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September 12, 2011 - NovaBay Pharmaceuticals' Reports Positive Results in Sinus Infection Study: The study, titled "Efficacy of NVC-422 Against Staphylococcus aureus Biofilms in a Sheep Model of Sinusitis," was conducted by Professor P.J. Wormald and his research team from the University of Adelaide in Australia in collaboration with researchers at NovaBay. It was presented at the 2011 meeting of the American Rhinologic Society in San Francisco on September 10.
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August 25, 2011 - NovaBay Pharmaceuticals Highlighted in Cataract & Refractive Surgery Today: The article, titled "Aganocide Compounds Show Activity Against Ophthalmic Agents," outlines NovaBay's development of Aganocide compounds for use as anti-infective agents to treat ophthalmic infections. Also covered were the company's recently completed Phase 2 clinical trial of its Aganocide NVC-422 for adenoviral conjunctivitis and a recent study of the activity of Aganocides NVC-727, NVC-638 and NVC-704 against ophthalmic pathogens.
- July 5, 2011 - NovaBay Pharmaceuticals Announces the Closing of its $5.2 Million Registered Direct Offering of Common Stock and Warrants: NovaBay combined its current cash and investments with the net proceeds of the financing and money received from Alcon and Galderma to support a number of clinical programs.
Management Comment:
Dr. Ron Najafi, Chairman and CEO, commented, "As reflected in our third quarter results, our financial statements were strengthened by funds provided from our recent financing. We are also making progress with our collaboration with Galderma in impetigo and our internal UCBE indication. We are particularly delighted that Dr. David Stroman has joined our management team to build on the positive data from our recent conjunctivitis trial and advance to the next phase. At the same time, we are looking forward to the market release of NeutroPhase in the coming year and the revenue opportunity it could bring to NovaBay. Our team continues to pursue our clinical milestones and we are working diligently to advance our programs."
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on developing its proprietary and patented Aganocide® compounds. These are novel, synthetic anti-infectives with activity against bacteria, fungi and viruses, and are being developed to treat and prevent a wide range of local, non-systemic infections with a low likelihood of developing bacterial resistance.
NovaBay is focusing its technology on four distinct therapeutic areas: dermatology, ophthalmology, urology and hospital infections. In dermatology, the focus is on developing NVC-422 gel for impetigo. NovaBay has the advantage of being partnered with Galderma, the leading dermatology company in the world. In ophthalmology, the goal is to develop an eye drop for conjunctivitis. In urology, NovaBay aims to reduce the incidence of urinary catheter blockage and encrustation (UCBE) and the potential for urinary tract infections with an irrigation solution containing NVC-422. In hospital infection, NovaBay is targeting the six-million-patient market in the U.S. of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers, with its proprietary anti-infective solution, NeutroPhase, which has received two 510(k) clearances from the Food and Drug Administration. For additional information, visit www.novabaypharma.com.
Cautionary Information Regarding Forward-Looking Statements
This release contains forward-looking statements, which are based upon NovaBay's current expectations, assumptions, estimates, projections and beliefs. The forward-looking statements in this press release include: NovaBay's plans to commence Phase 2b conjunctivitis trial in 2012; (ii) NovaBay's plan to commercialize NeutroPhase resulting in the availability of the product in the market in the first half of 2012, including its expectation that it will not directly market NeutroPhase; (iii) the expectation that the Phase 2b clinical study for the treatment of impetigo will commence during the fourth quarter, with data expected in the second half of 2012; and (iv) NovaBay's expectations regarding the timing of results from the UCBE trial. These statements are subject to risks and uncertainties that could cause actual results to differ materially 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 NovaBay may incur unexpected charges or need to or determined to engage in research and development or preclinical trials not previously planned, which could delay or prevent it from conducting or completing the clinical trials it expects; inherent risks and uncertainties relating to difficulties or delays in conducting clinical trials, which could delay or prevent the completion of clinical trials; results of clinical trials are uncertain, and results in previous preclinical trials may not be replicated in clinical trials, which may cause the outcome of clinical trials to be different than NovaBay expects; the inherent uncertainty of patent protection for the company's intellectual property or trade secrets, which could result in NovaBay not being able to protect its intellectual property to the extent that it expects; 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 its 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 Quarterly Report on Form 10-Q, under the caption "Risk Factors" in Item 1A of Part II of that report, which was filed with the Securities and Exchange Commission on August 10, 2011.The forward-looking statements in this press 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.