One To Watch
Kynexis
Company Overview
A Dutch clinical-stage neuropsychiatry biotech developing KYN-5356, a potential first-in-class KAT-II inhibitor targeting cognitive impairment associated with schizophrenia, a condition with no approved treatments. Kynexis is pursuing a mechanism that addresses cognitive deficits directly, rather than the psychotic symptoms that existing antipsychotics manage. With Phase II enrollment complete and topline data expected by end of 2026, the company is approaching its most consequential inflection point since launch.
Headquarters and Global Presence
Kynexis is headquartered in Naarden, the Netherlands. The company operates as a focused clinical-stage biotech, with its investor and scientific network spanning the Netherlands and Spain through its co-founding investors.
Founding and History
Kynexis was founded in 2023 and co-founded by venture firms Forbion and Ysios Capital. It launched in November 2023 with EUR 57 million in Series A financing.
Therapy Areas and Focus
Kynexis focuses on cognitive impairment associated with schizophrenia (CIAS), a core and severely disabling feature of the disease that existing antipsychotics do not adequately treat. Cognitive deficits, rather than psychosis, are the primary driver of long-term disability in schizophrenia patients.
No therapy has received regulatory approval specifically for CIAS, making it one of the largest unmet needs in neuropsychiatry. Kynexis believes a precision approach targeting the kynurenic acid pathway can fill that gap.
Technology Platforms and Modalities
Kynexis targets kynurenine aminotransferase II (KAT-II), an enzyme that synthesizes kynurenic acid in the brain. Elevated kynurenic acid acts as an endogenous antagonist at NMDA receptors and alpha-7 nicotinic receptors, both implicated in the cognitive deficits seen in schizophrenia.
By inhibiting KAT-II, KYN-5356 aims to restore receptor signaling and improve cognition through a mechanism distinct from all currently approved antipsychotics. The approach is grounded in substantial preclinical and translational evidence linking kynurenic acid dysregulation to schizophrenia pathophysiology.
Key Pipeline and Programs
KYN-5356 is Kynexis's sole disclosed clinical asset and its entire strategic focus. The small-molecule inhibitor targets KAT-II, lowering kynurenic acid in the brain to relieve blockade of NMDA and alpha-7 nicotinic receptors. The asset originated from Teva, providing a degree of prior development history before Kynexis acquired it.
KYN-5356 cleared Phase I with positive topline results, establishing a safety and tolerability profile that supported progression into Phase II. The ongoing Phase II study evaluates KYN-5356 in patients with cognitive impairment associated with schizophrenia. Enrollment in that study is now complete, with topline results expected before the end of 2026.
If Phase II data are supportive, the EUR 97 million Series A financing is intended to fund preparation for registrational studies, making the readout a direct gateway to a potential pivotal program.
Recent Developments
Novartis Venture Fund joined as a new investor in that round, alongside existing backers Forbion, Ysios Capital and Sunstone Life Science Ventures.
Enrollment in the Phase II study of KYN-5356 was completed ahead of the funding announcement, with topline results targeted for the end of 2026. The Novartis Venture Fund's entry is a notable validation signal, given its track record of backing assets it considers strategically relevant to Novartis's own therapeutic interests.
Key Personnel
Kees Been serves as Chief Executive Officer of Kynexis. Peter Hongaard Andersen, Dr.Med., serves as Executive Chair; he has held senior leadership positions at Lundbeck and Novo Nordisk and has co-founded multiple biotechnology companies, bringing deep neuropsychiatry and European biotech experience to the company.
Strategic Partnerships
Kynexis was co-founded by Forbion and Ysios Capital, which led the original EUR 57 million Series A in November 2023. Sunstone Life Science Ventures has participated in both financing rounds. KYN-5356 was originally sourced from Teva, representing the asset's licensing origin before Kynexis was established.
FAQ Section
Cognitive deficits are the primary driver of long-term disability in schizophrenia and are not meaningfully improved by any approved antipsychotic. Kynexis is betting that targeting the kynurenic acid pathway directly can achieve what dopamine-focused drugs have not. Regulatory approval in CIAS would address a patient population with no existing pharmacological option, representing a commercially clear opportunity in a space big pharma has largely deprioritized.
Kynurenine aminotransferase II (KAT-II) is the enzyme that converts kynurenine into kynurenic acid in the brain. Elevated kynurenic acid blocks NMDA receptors and alpha-7 nicotinic receptors, both of which are critical to learning, memory, and executive function. Inhibiting KAT-II reduces kynurenic acid, potentially restoring signaling at those receptors and correcting the cognitive deficits associated with schizophrenia.
KYN-5356 acts upstream by removing the endogenous antagonist at NMDA and alpha-7 receptors, rather than directly stimulating those receptors as some competitor approaches do. This indirect mechanism may offer a cleaner tolerability profile by modulating, rather than overriding, endogenous receptor activity. The asset's prior development history at Teva also means Kynexis inherited a degree of pharmacological characterization before beginning its own Phase I program.
Kynexis reported positive topline results from the Phase I study of KYN-5356, establishing the tolerability foundation needed to advance. The Phase II study targets patients with cognitive impairment associated with schizophrenia and has now completed enrollment. Topline results are expected by the end of 2026, and the EUR 97 million total Series A financing is explicitly sized to cover Phase II close-out and preparation for registrational studies should the data support it.
Kynexis describes itself as a precision neuropsychiatry company focused on brain diseases, with KYN-5356 in CIAS as its sole disclosed clinical program. The company's resources and financing are directed entirely at that single asset through Phase II and into registrational planning. Whether the KAT-II platform can be extended to other CNS indications with elevated kynurenic acid involvement has not been publicly detailed.
Kynexis is a clinical-stage company with KYN-5356 in Phase II, enrollment complete. The pivotal near-term milestone is topline Phase II data, expected before the end of 2026.
Kynexis is a single-asset company at a binary inflection point.
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