Reported that NYX-2925 met primary and secondary endpoints in Phase 2 fibromyalgia study
On track to initiate three additional Phase 2 studies in 2H 2019 across pipeline of CNS product candidates
Conference call today at
“We made substantial business and clinical progress in the second quarter,” said
Second Quarter 2019 and Recent Highlights
- Reported that NYX-2925 met primary and secondary endpoints in a Phase 2 study in patients with fibromyalgia. In
June 2019, Aptinyxreported positive results from a Phase 2 neuroimaging study of NYX-2925 in patients with fibromyalgia. In the study, administration of NYX-2925 resulted in statistically significant effects on the primary endpoint, neuroimaging biomarkers associated with pain processing. NYX-2925 demonstrated statistically significant reductions in connectivity and glutamate levels in brain regions that are known to be involved in the processing of centralized chronic pain. Statistically significant effects were also observed on secondary endpoints, including improvements in patient-reported pain and other symptoms of fibromyalgia. The company expects to initiate a Phase 2 fibromyalgia study focused on patient-reported symptoms in the second half of 2019.
- Reported data demonstrating robust activity of NYX-783 on alcohol-seeking behavior and relapse-like behavior in multiple preclinical models of alcohol use disorder. In
June 2019, Aptinyxreported findings from preclinical studies that support the potential of NYX-783 in treating alcohol use disorder. In an alcohol-dependence model and a stress-induced alcohol-seeking model, rodents dosed with NYX-783 showed significantly more rapid elimination of alcohol-seeking behavior compared to vehicle-treated rodents. NYX-783 also led to significantly less relapse-like behavior across both models. These data support the continued evaluation of NYX-783 and indicate that NYX-783 may be an effective approach to addressing alcohol abuse in patients with or without comorbid PTSD.
- Initiation of Phase 2 study of NYX-2925 in patients with painful diabetic neuropathy in 2H 2019.
- Initiation of Phase 2 study of NYX-2925 in patients with fibromyalgia in 2H 2019.
- Initiation of Phase 2 study of NYX-458 in patients with mild cognitive impairment in Parkinson’s disease in 2H 2019.
- Completion of, and reporting top-line data from, Phase 2 first-in-patient study of NYX-783 in PTSD in 2H 2020.
Second Quarter 2019 Financial Results
Cash Position: Cash and cash equivalents were
Collaboration and Grant Revenue: Revenue was
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Net loss was
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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the company’s business plans and objectives, including future plans or expectations for the company’s product candidates, therapeutic effects of the company’s product candidates, expectations regarding the design, implementation, timing, and success of its current and planned clinical studies, the timing for the company’s receipt of data from its clinical studies, expectations regarding its preclinical development activities, and expectations regarding its uses and sufficiency of capital. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the company’s product candidate development activities and planned clinical studies; the company’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in
CONDENSED BALANCE SHEETS
|Assets||June 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||124,891||$||150,637|
|Prepaid expenses and other current assets||2,878||1,784|
|Total current assets||128,471||153,251|
|Property and equipment, net and other long-term assets||1,700||2,363|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||3,944||3,996|
|Total current liabilities||4,778||5,885|
|Other long-term liabilities||347||418|
|Total liabilities and stockholders’ equity||$||130,171||$||155,614|
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|Three Months Ended
|Six Months Ended
|Research and development||9,481||13,686||21,971||25,911|
|General and administrative||4,171||2,022||9,896||4,071|
|Total operating expenses||13,652||15,708||31,867||29,982|
|Loss from operations||(12,727||)||(13,580||)||(30,052||)||(25,389||)|
|Net loss and comprehensive loss||$||(12,131||)||$||(13,335||)||$||(28,842||)||$||(25,007||)|
|Net loss per share - basic and diluted||$||(0.36||)||$||(1.83||)||$||(0.86||)||$||(3.95||)|
|Weighted average shares outstanding - basic and diluted||33,493||7,275||33,442||6,332|
Source: Aptinyx Inc.