Catalyst Pharmaceuticals Inc (NASDAQ:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today reported financial results for the third quarter and nine months ended September 30, 2015.

“The third quarter was a very productive period for the Catalyst team, with the initiation of the rolling submission of our New Drug Application for the use of Firdapse® in the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS)”, said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst.  “We expect to complete the submission this quarter and at that time will be requesting a priority review.”

Mr. McEnany added, “We continue to advance our preparations for the planned commercial launch of Firdapse to treat LEMS, and we remain focused on additional development efforts with Firdapse as a potential therapy for other neuromuscular diseases that represent unmet medical needs.”

Q3 and Recent Highlights:

  • Initiated rolling NDA submission for Firdapse for the treatment of LEMS
  • Appointed Paul J. Merrigan as Chief Commercial Officer
  • Development and advancement of comprehensive commercialization and pre-launch plan for Firdapse
  • Announced intent to develop generic equivalent of Sabril® (vigabatrin)
  • Announced a blinded clinical trial for pediatric patients with congenital myasthenic syndromes (CMS)
  • Announced notice of allowance of a U.S. patent application for the method of treating Tourette’s Disorder with GABA aminotransferase inactivators
  • Announced poster presentation on results from the Tourette’s investigator sponsored study at 62nd Annual Meeting of the American Academy of Child and Adolescent Psychiatry

Upcoming 2015 Milestones:

  • Expected completion of NDA submission of Firdapse for the treatment of LEMS during this quarter
  • Announcement of topline results from a Phase 1(b) multiple dose safety and tolerance study for CPP-115 during this quarter
  • Developing additional data to support use of Firdapse in the treatment of certain types of CMS
  • Exploration of additional indications for Firdapse including a subset of Myasthenia Gravis (antibody positive MuSK)

Financial Results

For the quarter ended September 30, 2015, Catalyst reported a GAAP net loss of $4,449,038, or 5 cents per basic and diluted share, compared to a GAAP net loss of $5,009,892, or 7 cents per basic and diluted share, for the same period in 2014. Excluding a non-cash gain of $521,731 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $4,970,769 or 6 cents per basic and diluted share for the third quarter of 2015. In comparison, Non-GAAP1 net loss for the third quarter of 2014 was $4,103,105, or 6 cents per basic and diluted share, which excludes non-cash expense of $906,787 attributable to the change in fair value of liability-classified warrants.

For the nine months ended September 30, 2015, Catalyst reported a GAAP net loss of $14,417,800, or 18 cents per basic and diluted share, compared to a GAAP net loss of $12,019,031, or 19 cents per basic and diluted share, for the same period in 2014. Excluding non-cash expense of $324,591attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $14,093,209 or 18 cents per basic and diluted share for the first nine months of 2015. In comparison, Non-GAAP1 net loss for the first nine months of 2014 was $10,553,139, or 17 cents per basic and diluted share, which excludes non-cash expense of $1,465,892 attributable to the change in fair value of liability-classified warrants.

Research and development expenses for the third quarter of 2015 were $3,042,671 compared to $2,885,892 in the third quarter of 2014. For the nine months ended September 30, 2015 research and development expenses were $7,969,731 compared to $7,733,533 in the same period in 2014.  Research and development expenses increased when compared to the same period in 2014 as we increased activities related to our NDA filing for Firdapse and ongoing studies and trials and decreased activities related to our completed Phase 3 trial for Firdapse. We expect that our research and development spend for the rest of the year will increase as we prepare for and submit our NDA for Firdapse and as we increase activities in other ongoing studies and trials.

General and administrative expenses for the third quarter of 2015 totaled $1,974,757 compared to $1,223,137 in the third quarter of 2014. For the nine months ended September 30, 2015 general and administrative expenses were $6,236,942 as compared to $2,874,034 in the same period in 2014.The increase when compared to the same period in 2014 is primarily due to increases in pre-commercialization expenses and headcount, in preparation for the future commercialization of Firdapse.

As a development-stage biopharmaceutical company, Catalyst had no revenues in the third quarter of 2015 and 2014 or the first nine months of 2015 and 2014. (Original Source)

Shares of Catalyst Pharmaceutical Partners opened today at $3.20. CPRX has a 1-year high of $5.80 and a 1-year low of $2.55. The stock’s 50-day moving average is $3.33 and its 200-day moving average is $3.92.

On the ratings front, Catalyst has been the subject of a number of recent research reports. In a report issued on September 10, Roth Capital analyst Scott Henry maintained a Buy rating on CPRX, with a price target of $7, which represents a potential upside of 118.8% from where the stock is currently trading. Separately, on August 11, Piper Jaffray’s Charles Duncan reiterated a Buy rating on the stock and has a price target of $7.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Scott Henry and Charles Duncan have a total average return of 13.2% and 12.4% respectively. Henry has a success rate of 42.5% and is ranked #260 out of 3829 analysts, while Duncan has a success rate of 47.9% and is ranked #450.

Catalyst Pharmaceuticals Inc is a biopharmaceutical company. The Company is engaged in the development and commercialization of prescription drugs targeting rare (orphan) neurological diseases and disorders.