NuPathe Announces First Quarter 2012 Financial Results and Operational Highlights
Resubmission of Migraine Patch NDA Remains on Track for the First Half of 2012
MarketwirePress Release: NuPathe Inc. – Thu, May 10, 2012 7:30 AM EDT
CONSHOHOCKEN, PA--(Marketwire -05/10/12)- NuPathe Inc. (PATH), a biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced financial results for the quarter ended March 31, 2012, and recent operational highlights.
"In the first quarter, we continued to prepare for the resubmission of the NDA for our migraine patch," said Jane Hollingsworth, chief executive officer of NuPathe. "With resubmission expected in the first half of 2012 and an anticipated six-month review, we look forward to providing a valuable new treatment option to the millions of migraine patients who suffer from debilitating migraine-related nausea along with their headache pain."
Recent Highlights
Following receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in August of 2011 for the Company's migraine patch (NP101), NuPathe has made significant progress toward addressing all of the questions raised in the CRL. NuPathe remains on track to resubmit its NDA in the first half of 2012 and expects the resubmission will result in a six-month review by the Agency.
In January, the USPTO issued a notice of allowance for U.S. Patent application 12/142,604 entitled "Pharmacokinetics of Iontophoretic Sumatriptan Administration." This application relates to methods of treating a migraine by administering sumatriptan using an iontophoretic patch to achieve consistent therapeutic plasma levels with low patient-to-patient variability. Given this action, NuPathe expects the patent to issue within the next few months. Once issued, it will provide additional patent protection for NP101 through April 2027.
In February, the United States Patent and Trademark Office (USPTO) issued a notice of allowance for U.S. Patent application 11/183,232 entitled "Drug Containing Implants and Methods of Use Thereof." This application relates to a biodegradable polymer implant as well as novel methods of treating schizophrenia, bipolar disorder and other specified psychiatric disorders with the implant by delivering therapeutic levels of risperidone, 9-hydroxy-risperidone, or haloperidol for 20 to 190 days. Given this action, NuPathe expects the patent to issue within the next few months. Once issued, it will provide patent protection through January 2025 for NP202, NuPathe's long-term biodegradable risperidone implant for the treatment of schizophrenia and bipolar disorder.
First Quarter 2012 Financial Results
NuPathe reported a net loss of $6.3 million for the first quarter of 2012, compared with a net loss of $3.7 million for the first quarter of 2011.
Research and development expenses were $3.5 million in the first quarter of 2012, compared with $1.6 million in the first quarter of 2011. This increase was primarily attributed to the fact that the first quarter of 2011 included a $1.5 million credit for our NDA filing fee that was refunded to the Company. Excluding this credit, research and development expenses for the first quarter of 2011 would have been $3.1 million, compared with $3.5 million for 2012. The increase in 2012 was attributable to higher CMC expenses related to the CRL response, partially offset by lower clinical and medical affairs expenses.
Selling, general and administrative expenses were $2.4 million in the first quarter of 2012, compared with $2.0 million for the same period in 2011. This increase was primarily attributable to increased headcount in the sales and marketing area.
Net cash used in operating activities for the three months ended March 31, 2012 was $6.2 million, primarily the result of spending for normal operating activities, activities to address questions raised in the CRL and the continued development of NP101. During the three months ended March 31, 2012, the Company used $0.1 million of cash in investing activities and $2.2 million of cash for financing activities related to contractual debt repayments.
As of March 31, 2012, NuPathe had $14.6 million in cash and cash equivalents and $3.0 million of working capital, compared with $23.1 million in cash and cash equivalents and $11.0 million of working capital as of December 31, 2011. The Company expects its existing cash and cash equivalents will be sufficient to fund operations, debt service and interest obligations into the third quarter of 2012. Additional capital will be needed by the Company to fund its operations and meet its capital requirements beyond that point. To meet its capital needs, NuPathe is considering multiple alternatives, including, but not limited to, additional equity financings, debt financings, corporate collaboration and licensing agreements, and other funding transactions. There can be no assurance that NuPathe will be able to complete any such transaction on acceptable terms or otherwise.
Market Data 
Markets 
AI
