Completed enrollment in Phase 2 study of NYX-2925, top-line data anticipated in the first half of 1Q 2019
Reported demonstration of NYX-2925 pharmacodynamic activity in humans
Plan to announce data from interim analysis of exploratory fibromyalgia study in
“We are extremely pleased with our accomplishments over the past quarter, our first full quarter as a public company,” said
Third Quarter 2018 and Recent Highlights
- Completed enrollment for Phase 2 study of NYX-2925: In
November 2018, Aptinyxannounced completion of enrollment for its Phase 2 study of NYX-2925 in subjects with painful diabetic peripheral neuropathy. The company expects to announce top-line data from the study in the first half of the first quarter of 2019.
- Reported demonstration of NYX-2925 pharmacodynamic activity in healthy volunteers: In
November 2018, Aptinyxannounced data from its studies of the pharmacodynamic effects of NYX-2925 in healthy volunteers. In two exploratory studies, NYX-2925 demonstrated NMDA receptor-mediated activity, including enhancement of synaptic plasticity and improvements on various sleep parameters. These data represent the first evidence in humans of pharmacodynamic activity of NYX-2925 at dose levels also under evaluation in the ongoing Phase 2 studies.
- Presented preclinical data on NYX-2925 and NYX-458 at the 48th Annual Meeting of the
Society for Neuroscience: In October 2018, Aptinyxpresented preclinical data on NYX-2925 demonstrating enhanced synaptic plasticity in rats and dendritic spine-autonomous structural and functional plasticity in vitro, which support its ongoing clinical development for the treatment of chronic pain conditions. The company also presented data demonstrating long-lasting pro-cognitive effects of NYX-458 in various preclinical models, supporting its ongoing clinical development for the treatment of cognitive impairment.
- Presented preclinical data on NYX-2925 at
International Association for the Studyof Pain’s 17th World Congress on Pain: In September 2018, Aptinyxpresented preclinical data on NYX-2925, demonstrating robust activity in preclinical models of numerous neuropathic pain conditions and a favorable tolerability profile.
- Presented preclinical data from NYX-783 at Military Health System Research Symposium: In
August 2018, Aptinyxpresented preclinical data on NYX-783 showing that the product candidate enhances learning and memory and also ameliorates affective and cognitive deficits in preclinical models of post-traumatic stress disorder (PTSD) and traumatic brain injury.
Expected Upcoming Milestones
- Reporting of data from interim analysis of Phase 2 exploratory study of NYX-2925 in subjects with fibromyalgia in December of 2018.
- Reporting of top-line data from Phase 2 study of NYX-2925 in subjects with painful diabetic peripheral neuropathy in the first half of the first quarter of 2019.
- Reporting of top-line data, including all study subjects, from Phase 2 exploratory study of NYX-2925 in subjects with fibromyalgia in first half of 2019.
- Completion of Phase 1 clinical study of NYX-458, in development for the treatment of cognitive impairment associated with Parkinson’s disease, in healthy volunteers in first half of 2019.
- Reporting of data from Phase 2 study of NYX-783 in subjects with PTSD in second half of 2019.
Third Quarter 2018 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
Aptinyx Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of proprietary synthetic small molecules for the treatment of brain and nervous system disorders. Aptinyx has a platform for discovery of novel compounds that work through a unique mechanism to modulate – rather than block or over-activate – NMDA receptors and enhance synaptic plasticity, the foundation of neural cell communication. The company has three product candidates in clinical development in central nervous system indications, including chronic pain, post-traumatic stress disorder, and cognitive impairment associated with Parkinson’s disease. Aptinyx is also advancing additional compounds from its proprietary discovery platform, which continues to generate a rich and diverse pipeline of small-molecule NMDA receptor modulators with the potential to treat an array of neurologic disorders. For more information, visit www.aptinyx.com.
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, expectations regarding the design, implementation, enrollment, timing, and success of its current and planned clinical trials, expectations regarding its preclinical development activities, and expectations regarding its uses 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 trials; the company’s ability to execute on its strategy; regulatory developments in
CONDENSED BALANCE SHEETS
|Assets||September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||165,578||$||92,136|
|Prepaid expenses and other current assets||1,169||1,960|
|Total current assets||167,592||95,033|
|Property and equipment and other long-term assets||2,487||2,289|
|Liabilities and stockholders’ equity (deficit)|
|Accrued expenses and other current liabilities||6,465||2,835|
|Total current liabilities||7,673||4,372|
|Other long-term liabilities||435||282|
|Convertible preferred stock||-||132,386|
|Stockholders’ equity (deficit)||161,971||(39,718||)|
|Total liabilities and stockholders’ equity (deficit)||$||170,079||$||97,322|
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|Three Months Ended
|Nine Months Ended
|Collaboration and grant revenue||$||943||$||1,205||$||5,535||$||3,778|
|Research and development||11,950||8,067||37,860||24,930|
|General and administrative||3,782||1,318||7,853||3,819|
|Total operating expenses||15,732||9,385||45,713||28,749|
|Loss from operations||(14,789||)||(8,180||)||(40,178||)||(24,971||)|
|Net loss and comprehensive loss||$||(14,181||)||$||(8,145||)||$||(39,188||)||$||(24,842||)|
|Net loss per share - basic and diluted||$||(0.43||)||$||(1.56||)||$||(2.48||)||$||(4.82||)|
|Weighted average shares outstanding - basic and diluted||33,191||5,232||15,789||5,159|
Stern Investor Relations, Inc.
Source: Aptinyx Inc.