Catalyst Pharmaceuticals Announces Second Quarter 2016 Financial Results and Provides Product Development Update
"We were pleased to have reached agreement with the
Q2 and Recent Highlights
- Agreement with
FDA on a second Phase 3 Study Protocol for Firdapse in LEMS - Publication of detailed results from the LMS-002 Phase 3 study of Firdapse in patients with LEMS in the
May 2016 issue of Muscle & Nerve authored by Dr.Shin Oh , et al. - Operating expense management plan to align resources is now complete
- Ended June 30, 2016 with approximately
$48 million in cash and investments and no debt
PRODUCT DEVELOPMENT UPDATE
Firdapse for LEMS NDA resubmission plan
- Finalizing logistics to launch a small, efficient short-term second Phase 3 trial in the fourth quarter 2016
- Have met with most of our key opinion leaders and they are fully supportive of our plan for the second Phase 3 trial
- Anticipate having two clinical trial sites, one each on the east and west coasts of the
U.S. - Anticipate enrolling up to 24 subjects, utilizing a cross-over design that we believe will be adequately powered
- The trial will have the same co-primary endpoints as the first Phase 3 trial (LMS-002)
FDA is permitting us to enroll subjects currently participating in our Expanded Access Program- Expect top-line data and an NDA resubmission (assuming favorable data) in the second half of 2017
Firdapse for Congenital Myasthenic Syndromes (CMS)
- Phase 3 trial currently underway and continues to identify and recruit patients at four sites
- Based on discussions with the
FDA , the study is being expanded to include adult CMS patients in addition to the pediatric population and to expand the total subjects in this trial to approximately 20 patients FDA is currently reviewing amended protocol and statistical analysis plan- Expect top-line data in the second half of 2017
- Assuming favorable data, we plan to include CMS in our NDA resubmission or as a supplement to the NDA
- Patients will be eligible to enroll in our Expanded Access Program at the completion of the study
Firdapse for MuSK antibody positive Myasthenia Gravis
- Approximately 5-8% of the Myasthenia Gravis patient population is estimated to be MuSK antibody positive
- Small phase 3 investigator-sponsored study currently underway at the
Carlo Besta Neurological Institute inMilan, Italy - Anticipate top line data in early 2017
- Assuming positive data from current study, we plan to initiate a registration-quality trial in the
U.S. - We have submitted a Special Protocol Assessment request to the
FDA for the proposedU.S. based trial
CPP-115 (next generation GABA-AT inhibitor)
- Additional dose optimization studies are required
- Other studies required to make CPP-115 "Phase 2 ready" include: long-term toxicology studies in two species; development and reproductive toxicology; and additional ADME studies
- Current cash resources are devoted to advancing Firdapse, as a result we are in discussions with several potential partners for the continued development of CPP-115
Generic Sabril® (generic ingredient vigabatrin)
- Sabril marketed in
U.S. by Lundbeck, and all Hatch-Waxman exclusivities expire byApril 2017 - Indicated for the treatment of refractory complex partial seizures and infantile spasms
- As of
July 21, 2016 FDA has relaxed the requirements under the REMS program for physicians to prescribe Sabril U.S. Sabril sales in 2015 as reported were approximately$144 million up 15% from 2014- Based on currently available information, Catalyst is hopeful that any ANDA submission that it makes for this product will be one of the first ANDA's submitted for a generic version of Sabril
Financial Results
For the quarter ended
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.
For the six months ended
Research and development expenses for the second quarter of 2016 were
General and administrative expenses for the second quarter of 2016 totaled
As a development-stage biopharmaceutical company, Catalyst had no revenues in the second quarter of 2016 and 2015 or the first six months of 2016 and 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. ET on Wednesday, August 10, 2016 to discuss the financial results and provide a product development 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 and CMS. 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, what study design for a second trial evaluation Firdapse for the treatment of LEMS will be acceptable to the
STATEMENTS OF OPERATIONS (unaudited) | |||||||||||||||||
For the Three Months Ended | For the Six Months Ended | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Operating costs and expenses: | |||||||||||||||||
Research and development | $ | 2,508,897 | $ | 2,577,508 | $ | 6,055,288 | $ | 4,927,060 | |||||||||
General and administrative | 2,305,555 | 2,319,822 | 4,996,700 | 4,262,185 | |||||||||||||
Total operating costs and expenses | 4,814,452 | 4,897,330 | 11,051,988 | 9,189,245 | |||||||||||||
Loss from operations | (4,814,452 | ) | (4,897,330 | ) | (11,051,988 | ) | (9,189,245 | ) | |||||||||
Other income, net | 92,755 | 4,871 | 210,698 | 66,805 | |||||||||||||
Change in fair value of warrants liability | 152,783 | 333,956 | 886,139 | (846,322 | ) | ||||||||||||
Loss before income taxes | (4,568,914 | ) | (4,558,503 | ) | (9,955,151 | ) | (9,968,762 | ) | |||||||||
Provision for income taxes | - | - | - | - | |||||||||||||
Net loss | $ | (4,568,914 | ) | $ | (4,558,503 | ) | $ | (9,955,151 | ) | $ | (9,968,762 | ) | |||||
Net loss per share - basic and diluted | $ | (0.06 | ) | $ | (0.06 | ) | $ | (0.12 | ) | $ | (0.13 | ) | |||||
Weighted average shares outstanding - basic and diluted | 82,870,649 | 82,037,560 | 82,865,366 | 79,054,960 |
CONDENSED BALANCE SHEETS | ||||||||
2016 | 2015 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 18,717,104 | $ | 28,235,016 | ||||
Certificates of deposit | 2,767,946 | 3,717,229 | ||||||
Short-term investments | 26,537,413 | 26,444,150 | ||||||
Prepaid expenses and other current assets | 650,977 | 1,504,738 | ||||||
Total current assets | 48,673,440 | 59,901,133 | ||||||
Property and equipment, net | 258,518 | 191,549 | ||||||
Deposits | 8,888 | 8,888 | ||||||
Total assets | $ | 48,940,846 | $ | 60,101,570 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 707,292 | $ | 1,794,127 | ||||
Accrued expenses and other liabilities | 1,598,165 | 1,646,476 | ||||||
Total current liabilities | 2,305,457 | 3,440,603 | ||||||
Accrued expenses and other liabilities, non-current | 188,032 | 176,293 | ||||||
Warrants liability, at fair value | 122,224 | 1,008,363 | ||||||
Total liabilities | 2,615,713 | 4,625,259 | ||||||
Total stockholders' equity | 46,325,133 | 55,476,311 | ||||||
Total liabilities and stockholders' equity | $ | 48,940,846 | $ | 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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