Apricus Biosciences, Inc. (APRI) Misses Q1 EPS by 6c; Cleared to Initiate RayVa Testing

Apricus Biosciences, Inc. (NASDAQ: APRI) reported Q1 EPS of ($0.09), $0.06 worse than the analyst estimate of ($0.03).

2014 Financial Outlook

In 2014, Apricus expects to generate cash from the potential out-license of Femprox and late in 2014, expects to begin to realize initial royalty revenues from partner sales of Vitaros. Apricus' expenditures in 2014 will include costs supporting the further development of the Vitaros room temperature device, the commercialization and launch of Vitaros in Europe, and the start of new clinical development programs.

Apricus believes it has an appropriate level of cash now to support the current operating plan into the second quarter of 2015, which includes conducting the RayVa Phase 2a clinical trial.

The company also announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application allowing the Company to initiate clinical testing of RayVa, Apricus' product candidate for the treatment of Raynaud's phenomenon. The Company expects to commence a Phase 2a clinical trial and begin enrollment in the second half of 2014. RayVa combines alprostadil, a vasodilator, with Apricus' proprietary permeation enhancer DDAIP.HCl, and is applied as an on-demand topical cream to affected extremities. In a nonclinical model, the Company demonstrated topical administration of alprostadil cream to cold-challenge statistically improved blood flow by 30 minutes relative to placebo, as measured by Laser Doppler. The improvement in blood flow was maintained out to 90 minutes post-challenge.

"We are excited to bring our third product candidate into the clinic, expanding our development pipeline beyond sexual health, and leveraging our proprietary permeation enhancer technology, to address Raynaud's phenomenon secondary to scleroderma, a disease that affects an estimated 100,000 people in the United States1," said Richard W. Pascoe, Chief Executive Officer. "Secondary Raynaud's phenomenon disproportionately affects women and currently has no approved therapy in the United States, representing an unmet medical need. Patients suffering from secondary Raynaud's phenomenon are typically treated by just over 4,500 rheumatologists in the United States2, thus providing Apricus with a potential path to building a focused commercial organization in the future."

The randomized, double-blind, placebo-controlled, Phase 2a trial is expected to enroll approximately fifty patients with Raynaud's phenomenon secondary to scleroderma. Each patient will receive applications of placebo and doses of RayVa, in a crossover design. This dose-ranging study will evaluate hemodynamics and temperature at the site of application in response to a cold challenge, as measured by Laser Doppler and thermography. Other endpoints include safety and pharmacokinetic assessments. The FDA has indicated that RayVa may qualify for priority review, given the unmet medical need and lack of approved products to treat secondary Raynaud's phenomenon. The FDA will determine if the RayVa New Drug Application qualifies for priority review following its submission, which could occur as early as 2017.

For earnings history and earnings-related data on Apricus Biosciences, Inc. (APRI) click here.

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