Adamas Reports Recent Achievements and Second Quarter 2017 Financial Results
"This is a very exciting time for Adamas, as we are potentially at the cusp of transitioning from a company focused on product development to a commercial entity marketing its own medicines," stated
Recent Achievements
- Presented expanded analysis from the ADS-5102 (amantadine extended
release capsules) open-label study at the 21st
International Congress of Parkinson's Disease and Movement Disorders (MDS) meeting showing tolerability and durability out to 88 weeks. The new subgroup analyses also showed that patients previously treated with immediate-release amantadine, who switched directly to ADS-5102, experienced a statistically significant benefit from ADS-5102 comparable to patients not previously treated with ADS-5102. - Published ADS-5102 Phase 3 EASE LID clinical trial data in JAMA Neurology online. The data demonstrated that ADS-5102 significantly reduced both dyskinesia and OFF time at six months in Parkinson's disease patients with levodopa-induced dyskinesia.
- Presented positive Phase 1a clinical trial data in a podium presentation at the 14th
Antiepileptic Drug and Device Trials Conference for ADS-4101 (lacosamide modified release capsules). The Phase 1 results showed that treatment with ADS-4101 resulted in reduced adverse events (including dizziness) compared to an equivalent dose of VIMPAT® (lacosamide) immediate-release tablets in healthy volunteers. - Initiated ADS-4101 Phase 1b steady-state study to evaluate the tolerability and pharmacodynamic profile of three ascending doses of ADS-4101 administered once daily at bedtime compared to ascending doses of twice daily VIMPAT (lacosamide) tablets. Announcement of topline data from the trial is expected in the third quarter of 2017.
- Signed
$100 million royalty-backed note agreement withHealthCare Royalty Partners . - Appointed
Alfred G. Merriweather as Chief Financial Officer.
Second Quarter 2017 Financial
Results
Adamas reported a net loss of
Research and development expenses were
General and administrative expenses for the second quarter ended
Six-month 2017 Financial Results
Adamas reported a net loss for the six months ended
Cash Position
Adamas ended the quarter with
Investor Conference Call and Webcast
Adamas will host a conference call and webcast today,
About
At Adamas, we believe in the power and the promise of medicines derived from a deep understanding of time-dependent biology. Our expertise lies in uncovering and mapping the relationship between disease and drug activity timing patterns. From there, we strive to create medicines with therapeutic profiles that match the pattern of disease to drive a more significant and durable clinical effect. This unique understanding of time-dependent biological processes informs our every innovation, targeting advancement in treatment of chronic neurologic disorders. Our proprietary portfolio includes ADS-5102, a high-dose amantadine therapy taken once-daily at bedtime, in development for the treatment of levodopa-induced dyskinesia in people
with Parkinson's disease as well as walking impairment in people with multiple sclerosis, and ADS-4101, a high-dose lacosamide therapy taken once-daily at bedtime, in development for the treatment of partial onset seizures in patients with epilepsy. The NDA for ADS-5102 is currently under review by the
NAMENDA XR® and NAMZARIC® are trademarks of
Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements contained in this press release regarding the potential approval of ADS-5102 for the treatment of levodopa-induced dyskinesia in patients
with Parkinson's disease. Words such as "potentially" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas' research, clinical, development, and commercial activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the
— Financial Tables Attached —
Unaudited Condensed Consolidated Statements of Operations | |||||||||||||||
(in thousands, except per share data) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Revenue | $ | 2 | $ | 222 | $ | 2 | $ | 397 | |||||||
Operating expenses | |||||||||||||||
Research and development | 7,176 | 9,224 | 14,264 | 16,746 | |||||||||||
General and administrative, net | 13,115 | 8,058 | 22,259 | 14,699 | |||||||||||
Total operating expenses | 20,291 | 17,282 | 36,523 | 31,445 | |||||||||||
Loss from operations | (20,289 | ) | (17,060 | ) | (36,521 | ) | (31,048 | ) | |||||||
Interest and other income, net | 222 | 184 | 426 | 344 | |||||||||||
Interest expense | (729 | ) | — | (729 | ) | — | |||||||||
Loss before income taxes | (20,796 | ) | (16,876 | ) | (36,824 | ) | (30,704 | ) | |||||||
Benefit for income taxes | (51 | ) | — | (51 | ) | — | |||||||||
Net loss | $ | (20,745 | ) | $ | (16,876 | ) | $ | (36,773 | ) | $ | (30,704 | ) | |||
Net loss per share, basic and diluted | $ | (0.93 | ) | $ | (0.78 | ) | $ | (1.65 | ) | $ | (1.43 | ) | |||
Weighted average shares used in computing net loss per share, basic and diluted | 22,392 | 21,650 | 22,300 | 21,452 | |||||||||||
Unaudited Consolidated Balance Sheet Data | |||||||
(in thousands) | |||||||
2017 | 2016 | ||||||
Cash, cash equivalents, and available-for-sale securities | $ | 144,929 | $ | 135,944 | |||
Total assets | 149,922 | 142,473 | |||||
Total current liabilities | 11,049 | 9,743 | |||||
Long-term debt | 33,768 | — | |||||
Total liabilities | 46,018 | 10,290 | |||||
Total stockholders' equity | 103,904 | 132,183 | |||||
Contact:Source:Ashleigh Barreto Director, Corporate Communications & Investor RelationsAdamas Pharmaceuticals, Inc. Phone: 510-450-3567 Email: ir@adamaspharma.com
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