NuPathe Announces Resubmission of Migraine Patch NDA Remains on Track for the First Half of 2012

NuPathe Inc.

today announced financial results for the quarter and full year ended December 31, 2011, and recent operational highlights. "During the fourth quarter and subsequently in 2012, we made substantial progress towards the resubmission of our New Drug Application for our migraine patch," said Jane Hollingsworth, chief executive officer of NuPathe. "We remain on track to resubmit the NDA in the first half of 2012 and are committed to making this valuable new treatment option available to the millions of migraine patients who suffer from debilitating migraine-related nausea along with their headache pain." Fourth Quarter and Full Year 2011 Financial Results NuPathe reported a net loss of $5.6 million for the fourth quarter of 2011, compared with a net loss of $6.2 million for the fourth quarter of 2010. For the full year 2011, NuPathe reported a net loss of $23.2 million, compared with a net loss of $24.4 million for the full year 2010. Research and development expenses were $3.2 million in the fourth quarter of 2011, compared with $5.2 million in the fourth quarter of 2010. The decrease was primarily due to a $1.5 million NDA filing fee in the fourth quarter of 2010 for NP101. Although this fee was refunded during the first quarter of 2011, it is a relevant factor when comparing the fourth quarter of 2011 with the same period in 2010. In addition to the $1.5 million filing fee, the fourth quarter of 2010 also included $0.9 million for a 12-month, repeat use trial of NP101 that had concluded prior to the fourth quarter of 2011 and $0.6 million related to the development of NP201 and NP202. While these expenses did not recur during the fourth quarter of 2011, the reduction was partially offset by expenses of $0.6 million in the fourth quarter of 2011 for two trials for NP101 that were initiated to respond to the CRL from the FDA. Selling, general and administrative expenses were $1.9 million in the fourth quarter of 2011, compared with $1.6 million for the same period in 2010. This increase was primarily due to higher commercial infrastructure expenses, including the growth of pre-commercialization activities related to the migraine patch.