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 second quarter and six months ended June 30, 2015.
“This quarter we have been working diligently to advance regulatory and commercial affairs and are pleased with the initiation of our rolling NDA submission to the FDA for Firdapse® for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS),” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “We expect to complete our submission during Q4, putting us on schedule for a potential approval by the middle of 2016. We are working on a pathway to include certain types of congenital myasthenic syndromes (CMS) in the initial label, in addition to LEMS. Additionally, we are on schedule with our key commercial strategic imperatives to support the successful launch of Firdapse®.”
Mr. McEnany added, “We recently reported top-line results in our proof-of-concept trial of vigabatrin in patients with treatment-refractory Tourette’s Disorder and are hoping to move forward using CPP-115 as a candidate for future trials.”
Q2 and Recent Highlights:
- Development and advancement of comprehensive commercialization and pre-launch plan
- Presented at the annual meeting of the American Academy of Neurology (AAN) in Philadelphia, PA
- Announced top-line results in proof-of-concept trial of Vigabatrin in patients with treatment-refractory Tourette’s Disorder
- Joined Russell 2000®, 3000® and Global Indexes
- Appointed Dr. Gary Ingenito as Chief Medical Officer
- Initiated rolling NDA submission for Firdapse® for the treatment of LEMS
Upcoming 2015 Milestones:
- Expected completion of NDA submission of Firdapse® for the treatment of LEMS during Q4
- Announcement of topline results from a Phase 1(b) multiple dose safety and tolerance study for CPP-115 in Q4
- 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)
- Hiring of a permanent chief commercial officer
For the quarter ended June 30, 2015, Catalyst reported a GAAP net loss of $4,558,503, or 6 cents per basic and diluted share, compared to a GAAP net loss of $3,198,020, or 5 cents per basic and diluted share, for the same period in 2014. Excluding non-cash gain of $333,956 attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $4,892,459 or 6 cents per basic and diluted share for the second quarter of 2015. In comparison, Non-GAAP1 net loss for the second quarter of 2014 was $2,974,429, or 5 cents per basic and diluted share, which excludes non-cash expense of $223,591 attributable to the change in fair value of liability-classified warrants.
For the six months ended June 30, 2015, Catalyst reported a GAAP net loss of $9,968,762, or 13 cents per basic and diluted share, compared to a GAAP net loss of $7,009,139, or 12 cents per basic and diluted share, for the same period in 2014. Excluding non-cash expense of $846,322attributable to the change in fair value of liability-classified warrants, Non-GAAP1 net loss was $9,122,440 or 12 cents per basic and diluted share for the first six months of 2015. In comparison, Non-GAAP1 net loss for the first six months of 2014 was $6,450,034, or 11 cents per basic and diluted share, which excludes non-cash expense of $559,105 attributable to the change in fair value of liability-classified warrants.
Research and development expenses for the second quarter of 2015 were $2,577,508 compared to $2,098,958 in the second quarter of 2014. For the six months ended June 30, 2015 research and development expenses were $4,927,060 compared to $4,847,641 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 second quarter of 2015 totaled $2,319,822 compared to $891,215 in the second quarter of 2014. For the six months ended June 30, 2015 general and administrative expenses were $4,262,185 as compared to $1,650,897 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 second quarter of 2015 and 2014 or the first six months of 2015 and 2014.
At June 30, 2015, Catalyst had cash and cash equivalents, certificates of deposit and short-term investments of $67.4 million and no debt. This includes proceeds from our February 2015 offering in which we sold 11.5 million shares of our common stock, and raised net proceeds of approximately $34.9 million. We believe that these resources give us sufficient runway through anticipated approval and subsequent product launch of Firdapse®, assuming approval in 2016. (Original Source)
Shares of Catalyst Pharmaceutical closed today at $4.37, down $0.07 or 1.58%. CPRX has a 1-year high of $5.80 and a 1-year low of $2.15. The stock’s 50-day moving average is $4.78 and its 200-day moving average is $4.11.
On the ratings front, Catalyst has been the subject of a number of recent research reports. In a report issued on July 22, Roth Capital analyst Scott Henry reiterated a Buy rating on CPRX, with a price target of $7, which represents a potential upside of 60.2% from where the stock is currently trading. Separately, on June 24, MLV & Co.’s Ram Selvaraju initiated coverage with a Buy rating on the stock and has a price target of $14.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Scott Henry and Ram Selvaraju have a total average return of 29.1% and 7.9% respectively. Henry has a success rate of 62.6% and is ranked #26 out of 3728 analysts, while Selvaraju has a success rate of 44.9% and is ranked #638.
Catalyst Pharmaceuticals Inc is abiopharmaceutical company. The Company is engaged in the development and commercialization of prescription drugs targeting rare (orphan) neurological diseases and disorders.