PSivida Corp. Provides Company Update And Reports Fourth Quarter And FY 2016 Results

WATERTOWN, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today provided a Company update and announced financial results for its fourth quarter and fiscal year ended June 30, 2016.

"Fiscal 2016 was a year of substantial progress for pSivida.  We significantly advanced Medidur™ for posterior segment uveitis toward planned EU and U.S. marketing applications, progressing toward a treatment with the potential to inhibit the disease for three years from a single injection without significant side effects and without systemic therapy," said Dr. Paul Ashton, president and chief executive officer of pSivida. "Additionally, fiscal 2016 marked the first use of our Durasert™ technology outside of ophthalmology with the commencement of an investigator-sponsored pilot study of a sustained-release implant being developed in collaboration with Hospital for Special Surgery designed to provide long-term pain relief for severe knee osteoarthritis. Also, based on pre-clinical studies completed in fiscal 2016, we commenced the first of two IND-enabling studies for an injectable, bioerodible Durasert insert for sustained delivery of a tyrosine kinase inhibitor (TKI) for treatment of wet age-related macular degeneration."

Business Highlights
  • The first of the two Phase 3 trials for Medidur for posterior segment uveitis met its primary efficacy endpoint of prevention of recurrence of disease at six months with high statistical significance (p less than 0.00000001, intent to treat analysis) with encouraging safety results.     
  • pSivida's utilization study of its proprietary, smaller diameter 27-gauge inserter met its primary endpoint, ease of intravitreal administration, showing it facilitated the administration of Medidur compared to the larger diameter inserter.
  • The European Commission designated Medidur as an orphan medicinal product and the Company plans to submit a European marketing authorization application (MAA) for Medidur under the centralized procedure in the first quarter of 2017 based on data from the single, first Phase 3 trial, the inserter utilization study and the ILUVIEN® for diabetic macular edema (DME) trials.
  • The second Medidur Phase 3 trial is expected to complete enrollment next month. Pending positive results, a U.S. new drug application (NDA) based on both Phase 3 trials is planned for the third quarter of 2017.
  • An investigator-sponsored pilot study commenced for a Durasert sustained-release implant being developed together with Hospital for Special Surgery that is designed to provide long-term pain relief for severe knee osteoarthritis.
  • Following the successful results of earlier reported animal studies comparing a TKI insert to an injection of a commercially available biologic indicated for wet AMD, pSivida commenced the first of two investigational new drug (IND)-enabling studies of the TKI insert for wet AMD.
  • Results of pSivida's pre-clinical studies of Tethadur™ reported in July demonstrated that Tethadur could provide prolonged, sustained delivery of Avastin® with high drug efficacy. pSivida plans to conduct additional pre-clinical studies seeking to develop Tethadur for ophthalmic and systemic delivery of biologics. 
  • In the first quarter of fiscal 2017, pSivida enhanced its research and product development with the addition of Dario Paggiarino, M.D. as chief medical officer. The Company also closed its U.K. research facility and consolidated all of its research into its state-of-the-art, cGMP U.S. facility coordinated by Dr. Paggiarino in an effort to improve the flow of research to product candidates while reducing overhead. 
  • pSivida replenished its capital resources with a $17.8 million underwritten public offering of common stock earlier in the year. 

Results for the Fourth Quarter and Year Ended June 30, 2016.  At June 30, 2016, cash, cash equivalents and marketable securities totaled $29.0 million compared to $28.5 million at the end of the prior year. In January 2016, pSivida enhanced its cash position with net proceeds of $16.5 million from an underwritten public offering of its common stock. Net operating cash usage in the fiscal 2016 fourth quarter totaled $4.3 million, the same as the prior quarter. Net operating cash usage is expected to increase during fiscal 2017 compared to fiscal 2016 and to vary from quarter to quarter during the fiscal year, primarily as a result of the amount and timing of payments for Medidur clinical development and regulatory submissions and, in the first quarter, the previously announced U.K. consolidation costs and incentive compensation payments.

Revenues for the quarter ended June 30, 2016 totaled $304,000 compared to $409,000 for the prior year quarter.

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