pSivida announced a net loss of $2.2 million for the quarter ended March 31, 2014, compared to a loss of $2.8 million for the same quarter last year.
The company attributed the reduced net loss primarily to an increase in revenues, which jumped to $2 million from $513,000 for the prior-year period. The revenue increase reflected $1.5 million for a completed feasibility study agreement.
The company also announced that it now plans to seek U.S. approval for its lead development product, Medidur for posterior uveitis, based on data from a phase 3 trial, with supplemental clinical data about the company's proprietary inserter if Iluvien for chronic diabetic macular edema is approved by the U.S. Food and Drug Administration. The phase 3 trial has already begun, and enrollment is continuing.
"Our revised regulatory strategy for Medidur has the potential to significantly accelerate U.S. commercial availability and reduce overall development costs. We remain optimistic that the FDA will approve Iluvien, which we believe will permit us to seek U.S. approval with data from a singlepPhase 3 trial for Medidur along with clinical data about our proprietary inserter. We plan to have a confirmatory meeting with the FDA with respect to our regulatory strategy as more data become available," said Dr. Paul Ashton, president and CEO of pSivida .
The company recently presented the first peer-reviewed, in-vitro data for Tethadur, its technology designed to provide sustained delivery of peptides, proteins and antibodies, demonstrating sustained delivery of Avastin with Tethadur. The study concluded that the release rate of antibodies such as Avastin is controllable over a wide range by adjusting the pore size and surface area of Tethadur. The company plans to report the results of additional pre-clinical studies of Tethadur later in calendar 2014, potentially positioning the Company to file an Investigatory New Drug Application.
Revenues for the nine months ended March 31, 2014 totaled $3.2 million compared to $1.7 million for the nine months ended March 31, 2013. The company reported a net loss of $9.4 million for the nine months ended March 31, 2014, compared to a net loss of $8 million for the same period of the prior year.
At March 31, 2014, cash, cash equivalents and marketable securities totaled $21.3 million compared to $15.7 million at December 31, 2013, primarily reflecting approximately $6.9 million received from a March 2014 registered direct offering of common stock.