Catalyst Pharmaceuticals Announces Third Quarter 2016 Financial Results and Provides Corporate Update
Q3 and Recent Highlights
- Reached agreement on a Special Protocol Assessment (SPA) with the
FDA for second phase 3 clinical trial evaluating Firdapse for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) - Firdapse granted orphan drug designation by the
FDA for the treatment of myasthenia gravis - Launched new website for its expanded access program
- Publication of CPP-115 Clinical Efficacy Data for Infantile Spasms in Epilepsy & Behavior Case Reports
- Ended Q3-2016 with $44.7 million in cash and investments and no debt
Upcoming 2016 Milestones
- Initiate the second Phase 3 trial for Firdapse to treat LEMS
- Continue to activate new sites and recruit patients for the study evaluating Firdapse in the treatment of patients with congenital myasthenic syndromes (CMS)
- Continue to support an investigator-sponsored study evaluating Firdapse for the treatment of MuSK antibody positive myasthenia gravis
- Ongoing development of generic equivalent of Sabril® (vigabatrin)
Financial Results
For the quarter ended
For the nine months ended
Research and development expenses for the third quarter of 2016 were
General and administrative expenses for the third quarter of 2016 totaled
As a development-stage specialty pharmaceutical company, Catalyst had no revenues in either the third quarter of 2016 or the third quarter of 2015.
At
More detailed financial information and analysis may be found in the Company's
Quarterly Report on Form 10-Q, which was filed with the
1 Statements made in this press release include a non-GAAP financial measure. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with generally accepted accounting principles (GAAP). This non-GAAP financial measure is intended to enhance an overall understanding of Catalyst's current financial performance. Catalyst believes that the non-GAAP financial measure presented in this press release provides investors and prospective investors with an alternative method for assessing Catalyst's operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. The non-GAAP financial measure in this press release excludes from the calculation of net loss the expense (or the income) associated with the change in fair value of the liability-classified warrants. Non-GAAP net loss per share is calculated by dividing non-GAAP net loss by the weighted average common shares outstanding.
Conference Call
Catalyst management will host an investment-community conference call and webcast at 8:30 a.m. EST on Thursday, November 10, 2016 to discuss the financial results and provide a corporate update. Investors who wish to participate in the conference call may do so by dialing (877) 407-8912 for domestic and Canadian callers or (201) 689-8059 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the Investors page of the company's website at www.catalystpharma.com and clicking on the webcast link on the Investors home page. A webcast replay will be available on the Catalyst website for 30 days following the call by visiting the Investor page of the company's website at www.catalystpharma.com.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), infantile spasms, and Tourette's Disorder. Firdapse® for the treatment of LEMS has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and orphan drug designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat infantile spasms, epilepsy and other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette's Disorder. CPP-115 has been granted U.S. orphan drug designation for the treatment of infantile spasms by the FDA and has been granted E.U. orphan medicinal product designation for the treatment of West Syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril® (vigabatrin).
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including whether the receipt of
breakthrough therapy designation for Firdapse will expedite the development and review of Firdapse by the FDA or the likelihood that the product will be found to be safe and effective, the timing on Catalyst's second trial evaluating Firdapse for the treatment of LEMS and whether the trial will be successful, whether Catalyst's assumptions in its updated business plan will be accurate and the impact of unanticipated events or delays in projected activities on Catalyst's cash requirements and on Catalyst's ability to get to an accepted NDA submission for Firdapse without the need for additional funding, what clinical trials and studies will be required before Catalyst can resubmit an NDA for Firdapse for the treatment of CMS and whether any such required clinical trials and studies will be successful, whether the investigator-sponsored study evaluating Firdapse for the treatment of
MuSK-MG will be successful, whether any NDA for Firdapse resubmitted to the
STATEMENTS OF OPERATIONS (unaudited) | |||||||||||||||||
For the Three Months Ended | For the Nine Months Ended | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Operating costs and expenses: | |||||||||||||||||
Research and development | $ | 2,493,999 | $ | 3,042,671 | $ | 8,549,287 | $ | 7,969,731 | |||||||||
General and administrative | 1,420,015 | 1,974,757 | 6,416,715 | 6,236,942 | |||||||||||||
Total operating costs and expenses | 3,914,014 | 5,017,428 | 14,966,002 | 14,206,673 | |||||||||||||
Loss from operations | (3,914,014 | ) | (5,017,428 | ) | (14,966,002 | ) | (14,206,673 | ) | |||||||||
Other income, net | 66,981 | 46,659 | 277,679 | 113,464 | |||||||||||||
Change in fair value of warrants liability | (106,948 | ) | 521,731 | 779,191 | (324,591 | ) | |||||||||||
Loss before income taxes | (3,953,981 | ) | (4,449,038 | ) | (13,909,132 | ) | (14,417,800 | ) | |||||||||
Provision for income taxes | - | - | - | - | |||||||||||||
Net loss | $ | (3,953,981 | ) | $ | (4,449,038 | ) | $ | (13,909,132 | ) | $ | (14,417,800 | ) | |||||
Net loss per share - basic and diluted | $ | (0.05 | ) | $ | (0.05 | ) | $ | (0.17 | ) | $ | (0.18 | ) | |||||
Weighted average shares outstanding - basic and diluted | 82,870,649 | 82,470,139 | 82,867,140 | 80,205,864 | |||||||||||||
CONDENSED BALANCE SHEETS | |||||||
2016 | 2015 | ||||||
(unaudited) | |||||||
ASSETS | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 17,638,100 | $ | 28,235,016 | |||
Certificates of deposit | 568,031 | 3,717,229 | |||||
Short-term investments | 26,538,304 | 26,444,150 | |||||
Prepaid expenses and other current assets | 310,855 | 1,504,738 | |||||
Total current assets | 45,055,290 | 59,901,133 | |||||
Property and equipment, net | 249,038 | 191,549 | |||||
Deposits | 8,888 | 8,888 | |||||
Total assets | $ | 45,313,216 | $ | 60,101,570 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current Liabilities: | |||||||
Accounts payable | $ | 1,055,324 | $ | 1,794,127 | |||
Accrued expenses and other liabilities | 940,271 | 1,646,476 | |||||
Total current liabilities | 1,995,595 | 3,440,603 | |||||
Accrued expenses and other liabilities, non-current | 185,095 | 176,293 | |||||
Warrants liability, at fair value | 229,172 | 1,008,363 | |||||
Total liabilities | 2,409,862 | 4,625,259 | |||||
Total stockholders' equity | 42,903,354 | 55,476,311 | |||||
Total liabilities and stockholders' equity | $ | 45,313,216 | $ | 60,101,570 | |||
Company ContactSource:Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com Investor ContactBrian Korb The Trout Group LLC (646) 378-2923 bkorb@troutgroup.com Media ContactsDavid Schull Matt Middleman , M.D.Russo Partners (212) 845-4271 (212) 845-4272 david.schull@russopartnersllc.com matt.middleman@russopartnersllc.com
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