Catalyst Pharmaceuticals Announces First Quarter 2016 Financial Results and Provides Corporate Update
"This past quarter has been very challenging, as we were very disappointed by the receipt of the refusal to file letter from the
Q1 and Recent Highlights
- Met with the
FDA to discuss and define a regulatory pathway forward for the Firdapse NDA - Appointed Brian Elsbernd as Senior Vice President of Legal and Compliance
- Announced initiation of investigator-sponsored study of Firdapse in patients with MuSK-antibody positive Myasthenia Gravis
- Ended
March 31, 2016 with$52.5 million in cash and investments and no debt
Upcoming 2016 Milestones
- Collaboratively working with the
FDA to finalize a regulatory path forward for Firdapse - Initiate the confirmatory Phase 3 trial for Firdapse to treat Lambert-Eaton myasthenic syndrome (LEMS)
- Evaluate our operating plan once the path forward to refile an NDA for Firdapse is determined, with a goal of completing the development of Firdapse and refiling an NDA using our current financial resources
- Continue to identify and recruit patients for the ongoing 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)
- Continue to evaluate the pharmacological properties of CPP-115, subject to the availability of funding
Financial Results
For the quarter ended
Research and development expenses for the first quarter of 2016 were
General and administrative expenses for the first quarter of 2016 totaled
As a development-stage specialty pharmaceutical company, Catalyst had no revenues in either the first quarter of 2016 or the first 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
Conference Call
Catalyst management will host an investment-community conference call and webcast at 8:30 a.m. EDT on Wednesday, May 11, 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. Firdpase for the treatment of LEMS has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designations for LEMS and CMS. Firdapse is the first and only drug approved in
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
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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.
STATEMENTS OF OPERATIONS (unaudited) | ||||||||||||||
For the Three Months Ended | ||||||||||||||
2016 | 2015 | |||||||||||||
Revenues | $ | -- | $ | -- | ||||||||||
Operating costs and expenses: | ||||||||||||||
Research and development | 3,546,391 | 2,349,552 | ||||||||||||
General and administrative | 2,691,145 | 1,942,363 | ||||||||||||
Total operating costs and expenses | 6,237,536 | 4,291,915 | ||||||||||||
Loss from operations | (6,237,536 | ) | (4,291,915 | ) | ||||||||||
Other income, net | 117,943 | 61,934 | ||||||||||||
Change in fair value of warrants liability | 733,356 | (1,180,278 | ) | |||||||||||
Loss before income taxes | (5,386,237 | ) | (5,410,259 | ) | ||||||||||
Provision for income taxes | -- | -- | ||||||||||||
Net loss | $ | (5,386,237 | ) | $ | (5,410,259 | ) | ||||||||
Net loss per share - basic and diluted | $ | (0.07 | ) | $ | (0.07 | ) | ||||||||
Weighted average shares outstanding - basic and diluted | 82,860,083 | 76,039,220 | ||||||||||||
CONDENSED BALANCE SHEETS | ||||||||
2016 | 2015 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 22,227,962 | $ | 28,235,016 | ||||
Certificates of deposit | 3,717,599 | 3,717,229 | ||||||
Short-term investments | 26,509,351 | 26,444,150 | ||||||
Prepaid expenses and other current assets | 1,023,892 | 1,504,738 | ||||||
Total current assets | 53,478,804 | 59,901,133 | ||||||
Property and equipment, net | 178,351 | 191,549 | ||||||
Deposits | 8,888 | 8,888 | ||||||
Total assets | $ | 53,666,043 | $ | 60,101,570 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 1,251,473 | $ | 1,794,127 | ||||
Accrued expenses and other liabilities | 1,412,314 | 1,646,476 | ||||||
Total current liabilities | 2,663,787 | 3,440,603 | ||||||
Accrued expenses and other liabilities, non-current | 190,471 | 176,293 | ||||||
Warrants liability, at fair value | 275,007 | 1,008,363 | ||||||
Total liabilities | 3,129,265 | 4,625,259 | ||||||
Total stockholders' equity | 50,536,778 | 55,476,311 | ||||||
Total liabilities and stockholders' equity | $ | 53,666,043 | $ | 60,101,570 | ||||
Investor ContactSource:Brian Korb The Trout Group LLC (646) 378-2923 bkorb@troutgroup.com Company ContactPatrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.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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