Catalyst Pharmaceuticals Announces Fourth Quarter and Year-End 2017 Financial Results and Provides Corporate Update
--Firdapse® NDA to be Resubmitted Before the End of this Quarter
--Significant Progress with MuSK-MG Regulatory and Clinical Program
--
--Company to Host Quarterly Conference Call at
"Throughout 2017, we made significant
progress in successfully completing our second Phase 3 trial evaluating Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) and successfully completing the required abuse liability studies that confirmed that Firdapse does not exhibit abuse potential. We also continued to build our rare neuromuscular disease platform as we prepared to enroll subjects in our Phase 3 clinical trial for MuSK antibody positive myasthenia gravis and our proof-of-concept clinical trial for spinal muscular atrophy Type 3," said
2017 and Recent Highlights
- Announced top-line results in LMS-003 trial, reaching both primary and secondary endpoints and completed required abuse liability studies
- Announced positive data from investigator-sponsored trial of Firdapse in treating MuSK antibody positive Myasthenia Gravis
- Confirmed timeline for NDA resubmission for Firdapse expected first quarter of 2018 following a positive Type C meeting recently held with the
FDA - Announced Phase 2 study of Firdapse in ambulatory patients with Spinal Muscular Atrophy (SMA) Type 3
- Reached an agreement with the
FDA under SPA for Phase 3 Firdapse in MuSK-MG trial - Reinitiated pre-commercialization activities for a potential launch of Firdapse
- Raised
$53.8M in net proceeds from a public offering in November - Ended December 31, 2017 with $84.0 million in cash and investments and no debt
Upcoming Milestones
- Resubmit NDA for Firdapse in the first quarter of 2018
- Enroll first subject in Phase 3 trial for MuSK-MG in H1 2018
- Enroll first subject in SMA Type 3 proof of concept trial in the second quarter of 2018
- Expect to complete enrollment in the Phase 3 CMS (CMS-001) trial before the end of 2018 and to report top-line results from this trial in the first quarter of 2019
Fourth Quarter and Full-Year 2017 Financial Results
For the year ended December 31, 2017, Catalyst reported a GAAP net loss of
For the quarter ended
Research and development expenses for the year ended December 31, 2017 were
General and administrative expenses for the year ended
Catalyst had no revenues in the year 2017 or 2016.
At December 31, 2017, Catalyst had cash and investments of $84 million and no debt. Based on its current financial position and its forecasts of available cash, Catalyst believes that it has sufficient funds to support its operations through 2019 (without considering revenues and cash receipts that may be received in 2019 if Catalyst is successful in obtaining an approval of Firdapse and launching the product in 2019, of which there can be no assurance).
More detailed financial information and analysis can be found in Catalyst's Annual Report on Form 10-K for the fiscal year ended
Conference Call
Catalyst management will host an investment-community conference call and webcast at 5:00 p.m. ET, today, Wednesday, March 14, 2018 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 is also developing CPP-115 to treat refractory infantile spasms. CPP-115 has been granted
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 (i) whether the results of the LMS-003 trial, combined with the results of the Company's previous Phase 3 trial, will be acceptable to 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
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
For the Three Months Ended | For the Year Ended | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Operating costs and expenses: | ||||||||||||||||
Research and development | $ | 3,404,634 | $ | 2,820,654 | $ | 11,375,237 | $ | 11,369,941 | ||||||||
General and administrative | 2,107,152 | 1,493,545 | 7,304,399 | 7,910,260 | ||||||||||||
Total operating costs and expenses | 5,511,786 | 4,314,199 | 18,679,636 | 19,280,201 | ||||||||||||
Loss from operations | (5,511,786 | ) | (4,314,199 | ) | (18,679,636 | ) | (19,280,201 | ) | ||||||||
Other income, net | 124,088 | 43,933 | 454,163 | 321,612 | ||||||||||||
Change in fair value of warrants liability | - | 106,946 | (186,904 | ) | 886,137 | |||||||||||
Loss before income taxes | (5,387,698 | ) | (4,163,320 | ) | (18,412,377 | ) | (18,072,452 | ) | ||||||||
Provision for income taxes | - | - | - | - | ||||||||||||
Net loss | $ | (5,387,698 | ) | $ | (4,163,320 | ) | $ | (18,412,377 | ) | $ | (18,072,452 | ) | ||||
Net loss per share - basic and diluted | $ | (0.06 | ) | $ | (0.05 | ) | $ | (0.21 | ) | $ | (0.22 | ) | ||||
Weighted average shares outstanding - basic and diluted | 91,451,695 | 82,899,526 | 85,802,487 | 82,875,281 | ||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS
2017 | 2016 | ||||
ASSETS | |||||
Current Assets: | |||||
Cash and cash equivalents | $ | 57,496,702 | $ | 13,893,064 | |
Short-term investments | 26,516,711 | 26,512,753 | |||
Prepaid expenses and other current assets | 1,173,744 | 1,047,944 | |||
Total current assets | 85,187,157 | 41,453,761 | |||
Property and equipment, net | 191,385 | 244,204 | |||
Deposits | 8,888 | 8,888 | |||
Total assets | $ | 85,387,430 | $ | 41,706,853 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
Current Liabilities: | |||||
Accounts payable | $ | 1,945,575 | $ | 933,176 | |
Accrued expenses and other liabilities | 2,320,587 | 1,161,359 | |||
Total current liabilities | 4,266,162 | 2,094,535 | |||
Accrued expenses and other liabilities, non-current | 157,456 | 181,162 | |||
Warrants liability, at fair value | - | 122,226 | |||
Total liabilities | 4,423,618 | 2,397,923 | |||
Total stockholders' equity | 80,963,812 | 39,308,930 | |||
Total liabilities and stockholders' equity | $ | 85,387,430 | $ | 41,706,853 |
Investor ContactSource:Brian Korb The Trout Group LLC (646) 378-2923 bkorb@troutgroup.com Media ContactDavid Schull Russo Partners (212) 845-4271 david.schull@russopartnersllc.com Company ContactPatrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com
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