Aptinyx Stock

Aptinyx Inc. (Aptinyx), a clinical-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of novel, proprietary, synthetic small molecules for the treatment of brain and nervous system disorders.

The company focuses its efforts on targeting and modulating N-methyl-D-aspartate receptors (NMDArs), which are vital to normal and effective function of the brain and nervous system.

The company's discovery platform is based on extensive original research into a novel way of modulating NMDArs. In particular, hypo-functioning of NMDA receptors in specific parts of the brain is implicated in a variety of neurological disorders, including each of the indications in the company's development pipeline.

The company's molecules bind in a previously uncharacterized binding domain, or pocket, on NMDArs that is distinct from that of other NMDAr-targeted therapies. The mechanism by which its molecules positively modulate NMDArs triggers a cascade of activity that ultimately strengthens the synaptic connections between neural cells, resulting in stronger connections over time between these cells. The communication between neural cells is not only essential to routine function of the nervous system, but also allows the cells of the nervous system to learn, or adapt in response to external stimuli, through a process called synaptic plasticity. The company's therapeutic approach, which positively modulates NMDArs to enhance synaptic plasticity, affecting learning and memory processes, holds great promise for alleviating multiple disorders of the brain and nervous system.

The company's lead asset, NYX-783, is in Phase 1 clinical development for the treatment of opioid use disorder (OUD), and in preclinical development for the treatment of alcohol use disorder (AUD). NYX-783 modulates NMDA receptors to increase glutamatergic activity in key regions and may act to enhance extinction learning and alleviate the emotional symptoms of opioid withdrawal. As of December 31, 2022, the company had completed preclinical studies relevant to OUD demonstrating NYX-783 was safe and well-tolerated, improved emotional withdrawal symptoms, and reduced drug-seeking behavior during withdrawal. It has also observed similar effects of NYX-783 in preclinical studies relevant to AUD.

In August 2022, the company announced that it was discontinuing the development of NYX-2925 after two Phase 2b studies in chronic pain failed to demonstrate sufficent efficacy to support continued investment by Aptinyx.

In February 2023, the company discontinued the development of NYX-458 in cognitive impairment associated with Parkinson's disease and dementia with Lewy bodies, following results from an exploratory Phase 2 clinical study in which NYX-458 did not demonstrate clinically meaningful improvements over placebo on the study's efficacy endpoints. The study results do not support continued development of NYX-458 by Aptinyx.

The company executed an early termination of its then-ongoing Phase 2b study of NYX-783 in post-traumatic stress disorder (PTSD) to enable an analysis of the data to date (as of February 27, 2023).

In March 2023, the company completed an analysis of the data available to date (as of February 27, 2023) from the first 100 patients enrolled in its Phase 2b clinical study evaluating the effects of NYX-783 in patients with PTSD. In the analysis, NYX-783 did not demonstrate sufficient improvement on the study's primary endpoint to support continued development of the program by Aptinyx. As a result, Aptinyx will discontinue future development of NYX-783 in PTSD.

In March 2023, the company announced that it is exploring strategic alternatives to engage Ladenburg Thalmann & Co. as its exclusive financial advisor to assist in this process.

Strategy

The company's strategy is to advance the development of NYX-783 as a novel treatment for OUD and AUD. The company's discovery platform has the potential to develop into a broad pipeline and product portfolio across an array of disorders of the brain and nervous system.

Future Development

The company intends to advance NYX-783 toward regulatory approval for the treatment of OUD and AUD. In addition to pursing U.S. Food and Drug Administration (FDA) approval in the United States in these indications, it plans to explore registrations outside of the United States in the most significant markets.

Research Collaboration Agreement with Allergan

The jointly funded research activities and option exercise period under the company's Research Collaboration Agreement (RCA) with Allergan plc (Allergan) (a subsidiary of AbbVie Inc. (AbbVie)) came to their contractual conclusions in August 2020 and February 2021, respectively. Consistent with the terms of the RCA, AbbVie optioned two compounds from the company's NMDAr modulator discovery platform.

Intellectual Property

NYX-2925 and NYX-783

As of February 15, 2023, the company owned two issued U.S. patents and one pending U.S. patent application, and pending and issued foreign counterpart patents and patent applications, that relate to both NYX-2925 and NYX-783. The company also owns one issued U.S. patent and two pending U.S. patent applications that relate to NYX-2925, and two issued U.S. patents, as well as one pending international patent application filed under the Patent Cooperation Treaty (PCT), that relate to NYX-783. An international PCT patent application is not eligible to become an issued patent until, among other things, the company files a patent application in regional or national patent offices within 30 or 31 months of filing of the earliest-filed priority patent application. The issued U.S. patents are expected to expire in 2034. If it continues to pursue patent protection and file one or more patent applications with respect to its pending international PCT patent application, and if any patents issue based on its pending applications, it expects such patents, if issued, to expire between 2034 and 2041.

NYX-458

As of February 15, 2023, the company owned three issued U.S. patents, and three pending U.S. patent applications, and pending and issued foreign counterpart patents and patent applications, that relate to its product candidate, NYX-458. The issued U.S. patents are expected to expire in 2037. If the company continues to pursue patent protection, and if any patents issue based on its pending applications, it expects such patents, if issued, to expire between 2037 and 2040.

Other Compounds

As of February 15, 2023, the company owned twenty issued U.S. patents, five pending U.S. patent applications, and pending and issued foreign counterpart patents and patent applications, as well as eight U.S. provisional patent applications, all of which generally relate to its efforts to develop other compounds in its NMDAr modulator small molecule program. Provisional patent applications are not eligible to become issued patents until, among other things, the company files a non-provisional patent application within 12 months of filing the provisional patent applications. The issued U.S. patents are expected to expire between 2034 and 2037. If the company continues to pursue patent protection and file one or more non-provisional patent applications with respect to its pending provisional patent applications, and if any patents issue based on its pending applications, the company expects such patents, if issued, to expire between 2034 and 2043.

Research and Development

The company's research and development expenses were $42.7 million for the year ended December 31, 2022.

Government Regulation

The company's product candidates must be approved by the FDA through the new drug application (NDA) process before they may be legally marketed in the United States. The company relies, and expects to continue to rely, on third parties for the production of clinical and commercial quantities of its products in accordance with current Good Manufacturing Practices (cGMP) regulations.

History

Aptinyx Inc. was founded in 2015. The company was incorporated under the laws of the state of Delaware in 2015.