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Seyltx Expands GluN2B Antagonist Pipeline with Clinical-Stage and Small-Molecule Candidates for Chronic Cough

- Company enters into option agreement with NeurOp to in-license novel GluN2B antagonists

- Compounds include a highly potent and selective Phase 1-complete candidate and seven preclinical candidates

- Combines the research and development capabilities of both companies to accelerate the discovery of centrally acting next-generation chronic cough treatments

Seyltx, Inc., (“Seyltx”, “Company”) a clinical-stage biotherapeutics company focused on developing therapies to treat chronic cough, today announced it has entered into an option agreement with NeurOp, Inc. (“NeurOp””) for a portfolio of novel GluN2B antagonists. This agreement provides Seyltx with an option to worldwide, exclusive rights to develop and commercialize a portfolio of GluN2B negative allosteric modulators (NAMs) for treating chronic cough in humans, including in refractory chronic cough (RCC) and chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF-Cough).

This strategic agreement combines Seyltx's expertise in chronic cough therapeutic development with NeurOp's expertise in NMDA receptor biology and innovative GluN2B inhibitors. This combination complements and deepens Seyltx’s ongoing development of Ifenprodil, a potent NMDA antagonist that is highly selective towards the GluN2B subunit, currently in Phase 2 development. The combined effort is expected to accelerate the development and commercialization of new therapies for chronic cough and solidify Seyltx's position as a leader in addressing this significant unmet medical need.

The option agreement includes 8 novel compounds, including NP10679, which has completed Phase 1 and provides Seyltx with a second clinical-phase candidate, with the potential to provide differentiated performance compared to Ifenprodil. These compounds have excellent potency, selectivity, pharmacokinetics, solubility, and metabolism. Strong intellectual property exists across all optioned compounds.

"We are incredibly excited about this option agreement with NeurOp, which significantly strengthens our pipeline for chronic cough therapies," said Dr. Dietrich A. Stephan, Seyltx’s CEO. "Refractory chronic cough impacts approximately 6 million people in the USA alone, representing a substantial unmet medical need. Furthermore, chronic cough associated with IPF, an orphan condition affecting up to 140,000 people in the US, is a primary driver of deteriorated quality of life for these patients. Our agreement with NeurOp for advanced GluN2B NAMs, particularly NP10679, offers a promising avenue to provide potentially superior treatment options to these patients by addressing the condition with a centrally acting non-narcotic solution."

Dr. James McNamara, Executive Chairman of NeurOp added, "NeurOp has been dedicated to advancing novel GluN2B-targeted therapies. This agreement with Seyltx is a testament to the sophistication of our team’s expertise in the NMDA receptor biology and the development of our GluN2B antagonists. Seyltx's deep understanding and focus on chronic cough make them an ideal partner to further develop and bring these important compounds to patients in need. We look forward to a very productive partnership."

NMDA is a validated therapeutic target in cough, with the only FDA-approved cough therapy being a non-specific NMDA antagonist. Preclinical research has identified the GluN2B subunit of NMDA as a primary target for cough suppression. Traditional non-specific NMDA antagonists have demonstrated limited efficacy due to dose limiting side effects. However, specifically targeting the GluN2B subunit, provides the potential to achieve robust cough suppression, while avoiding the adverse event profile observed with non-specific NMDA antagonists. The addition of NP10679 to the portfolio provides the opportunity to effectively engage the GluN2B receptor, below the safety threshold established in Phase 1, while offering a differentiated selectivity and efficacy profile compared to Ifenprodil.

The option agreement has been approved by the management of both companies with a conversion to an exclusive world-wide license agreement anticipated within 12 months.

About Seyltx: Seyltx (www.seyltx.com) is a clinical stage biotherapeutics company focused on developing innovative therapies to treat chronic cough and other neuronal hypersensitivity indications. Its lead indication is refractory chronic cough, a significant unmet medical need, with a follow-on opportunity in chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF-Cough). Seyltx's lead compound is Ifenprodil, an NMDA receptor inhibitor highly selective towards the GluN2B subunit, which has completed a Phase 2a trial in chronic cough associated with IPF, with statistically significant reductions in cough from baseline at 12-weeks, and statistically significant improvements on all patient reported outcomes employed. Seyltx is currently progressing into Phase 2 crossover trials.

About NeurOp: NeurOp, Inc. is a privately held, clinical-stage biopharmaceutical company based in Atlanta, Georgia that is developing small-molecule therapies for central nervous system disorders, including severe pain, treatment-resistant depression, subarachnoid hemorrhage (SAH) and stroke. Its proprietary compounds selectively inhibit the GluN2B subunit of neuronal NMDA receptors and are designed for potential therapeutic benefit with an improved safety and tolerability profile relative to other NMDA receptor antagonists.

Forward-Looking Statements: Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as “expects,” “anticipates,” “believes,” “intends,” “estimates,” “potential,” “possible,” “projects,” “plans,” and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond Seyltx's control.

"We are incredibly excited about this option agreement with NeurOp, which significantly strengthens our pipeline for chronic cough therapies," said Dr. Dietrich A. Stephan, Seyltx’s CEO.

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