In a release on
The non-GAAP net loss for the second quarter of 2014 was
The net loss according to accounting principles generally accepted in the U.S. (GAAP) for the second quarter of 2014 was
Research and development (R&D) expenses were
The increase in R&D expenses in the second quarter of 2014 as compared to the second quarter of 2013 was due primarily to additional expenses related to the significant advancement of certain of the company's clinical and pre-clinical programs. The company expects that R&D expenses will increase slightly for the second half of 2014 as certain of our programs move into late clinical stages.
In the second quarter of 2014, the company recorded a reduction of
In the second quarter of 2014, the company re-measured the expense recorded in the first quarter of 2014 in connection with these shares using the price of the company's common stock on the issuance date. In future periods, there will be no additional charges recorded to in-process research and development related to the purchase of the Sirna RNAi assets from Merck.
General and administrative (G&A) expenses were
The increase in G&A expenses in the second quarter of 2014 as compared to the second quarter of 2013 was due primarily to higher non-cash stock-based compensation expense. Excluding non-cash stock- based compensation expense, the company expects that G&A expenses will remain consistent for the second half of 2014.
"During the second quarter and recent period, we continued to execute on our expanded 'Alnylam 5x15' product development strategy and reported on multiple significant clinical and pre-clinical data sets. As we continue enrolling patients in our APOLLO Phase 3 trial with patisiran, we were pleased to report positive initial data from our ongoing Phase 2 open-label extension (OLE) study, showing sustained knockdown of serum TTR protein levels in addition to a favorable tolerability profile. Patients in the OLE study have been treated for up to nine months, and there have been no discontinuations. Enrollment also continues in our ALN-TTRsc Phase 2 study in TTR cardiomyopathy and we remain on track to initiate our Phase 3 trial later this year," said
"In addition to advancements in our clinical pipeline, we also made strong progress with our pre-clinical programs. First, we were pleased to select our Development Candidate for ALN-CC5 - an RNAi therapeutic targeting complement C5 for the treatment of complement- mediated diseases - and we remain on track to file our IND for this program in late 2014. Our new pre-clinical results with ALN-PCSsc - an RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia - highlight the potential for once-monthly or possibly once-quarterly subcutaneous dosing which we believe has the potential to be disruptive in a significant emerging market; we expect to file a clinical trial application (CTA) for ALN-PCSsc later this year. In addition, we selected a Development Candidate for our ALN-AAT program - an RNAi therapeutic targeting alpha-1 antitrypsin (AAT) for the treatment of AAT deficiency associated liver disease - with the goal of filing an IND for this program in mid-2015, and we added ALN-HBV - an RNAi therapeutic targeting the hepatitis B viral (HBV) genome for the treatment HBV infection - as a new program with the goal of filing an IND around year-end 2015. All of these programs employ our Enhanced Stabilization Chemistry (ESC) GalNAc-conjugate technology, that enables subcutaneous dosing with increased potency, durability, and a wide therapeutic index, and we are very encouraged by the potent knockdown and durability results emerging from our programs utilizing this improved technology," said
"Alnylam continues to maintain a very strong balance sheet, ending the second quarter with
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In a release on