Re: Farmas USA
rgls
halt
madre de dios
regular regular
Pipeline Update
RG-012 for the treatment of Alport Syndrome: The Company has completed dosing of RG-012 in its Phase I multiple ascending dose (MAD) study and has selected the dose for the upcoming Phase II HERA and renal biopsy studies, which is expected to commence mid-2017. Preliminary data from the MAD study indicated that RG-012 was well tolerated with no serious adverse events (SAEs) reported in any subjects. The plasma PK profile of RG-012 was in-line with expectations, with a dose dependent increase in plasma exposure seen across the three dose groups. Data from the renal biopsy study is anticipated by year-end 2017, and interim data from the Phase II HERA study is anticipated in mid-2018.
Q1 Financial Results
Cash Position: Cash, cash equivalents and short-term investments were $57.5 million at March 31, 2017, compared with $76.1 million at December 31, 2016.
Research and Development (R&D) Expenses: R&D expenses were $15.8 million for the quarter ended March 31, 2017, compared to $16.8 million for the quarter ended March 31, 2016. The decrease in R&D expenses was primarily driven by a decrease in spend on the RG-101 program due to the FDA clinical hold, partially offset by an increase in internal costs attributable to our preclinical pipeline.
General and Administrative (G&A) Expenses: G&A expenses were $4.0 million for the quarter ended March 31, 2017, compared to $5.1 million for the quarter ended March 31, 2016.
Revenue: Revenue was less than $0.1 million for the quarter ended March 31, 2017, compared to $0.5 million for the quarter ended March 31, 2016.
Net Loss: Net loss was $20.0 million, or $0.38 per share (basic and diluted), for the quarter ended March 31, 2017, compared to a net loss of $21.2 million, or $0.40 per share (basic and diluted), for the quarter ended March 31, 2016.
