Kynexis Extends Series A to €97 Million to Advance First-in-Class KAT-II Inhibitor for Cognitive Impairment in Schizophrenia
核心洞察
Kynexis (搜索) closed a €40 million Series A extension led by Novartis Venture Fund (搜索), bringing total Series A financing to €97 million ($110 million).
The financing supports Phase 2 close-out and registrational preparation for KYN-5356, a potential first-in-class oral KAT-II (搜索) inhibitor for cognitive impairment associated with schizophrenia (搜索) (CIAS).
The company has completed enrollment in its Phase 2 proof-of-concept study and remains on track to report topline results by the end of 2026.
Kynexis (搜索), a clinical-stage biotechnology company based in Naarden, the Netherlands, announced the closing of a €40 million ($45 million) extension to its Series A financing, bringing total Series A funding to €97 million ($110 million). The extension was led by new investor Novartis Venture Fund (搜索), with participation from existing backers Forbion (搜索), Ysios Capital, and Sunstone Life Science Ventures. The proceeds will support completion of the company's Phase 2 proof-of-concept study of KYN-5356, an investigational KAT-II (搜索) inhibitor targeting cognitive impairment associated with schizophrenia (搜索) (CIAS), as well as preparations for registrational development.
"We are pleased to welcome Novartis Venture Fund (搜索) to our existing investor syndicate as we continue to execute on our vision of building Kynexis (搜索) into a leading late-stage cognition company," said Kees Been, Chief Executive Officer of Kynexis. "This financing enables us to continue clinical development of KYN-5356 and begin preparing for registrational studies in CIAS. We believe our novel KAT-II (搜索) inhibition approach has the potential to address cognitive dysfunction across multiple neurological and neurodegenerative disorders."
In connection with the closing, Novartis Venture Fund (搜索)'s Marianne Uteng joined Kynexis (搜索)'s board of directors, and Mathias Frederiksen joined as a board observer. The original Series A of €57 million was raised at the company's launch in November 2023, led by Forbion (搜索).
Mechanism of Action and Unmet Need
KYN-5356 is an investigational oral small-molecule inhibitor of KAT-II (搜索), the primary enzyme responsible for producing kynurenic acid (KYNA) in the brain. Elevated KYNA is associated with disrupted signaling through NMDA and alpha-7 nicotinic receptors, which contributes to the learning, memory, and executive function deficits characteristic of CIAS. By inhibiting KAT-II and reducing KYNA, KYN-5356 is designed to help restore the balance of signaling required for cognitive function.
No approved therapy currently addresses CIAS directly. Competitors in the cognitive impairment space include programs targeting AMPA receptors and other glutamatergic mechanisms, though Kynexis (搜索) describes KYN-5356 as the most advanced clinical-stage program specifically targeting this indication.
Phase 2 Trial Design and Status
Kynexis (搜索) has completed enrollment in its randomized, double-blind, placebo-controlled Phase 2 trial evaluating KYN-5356 in approximately 150 adults with CIAS across 13 clinical sites in the United States. Over a 28-day treatment period, the study is evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of KYN-5356 as an adjunctive treatment for CIAS. Topline results are expected by the end of 2026, with the current financing intended to cover close-out activities and fund preparations for a subsequent registrational program.
The Phase 2 trial builds on positive results from the company's Phase 1 study in healthy volunteers, in which KYN-5356 demonstrated a favorable safety and tolerability profile, central nervous system penetration, dose-dependent reductions in cerebrospinal fluid KYNA, and early evidence supporting its mechanism of action. Further details are available at www.clinicaltrials.gov (Identifier: NCT07191483).
Expansion Plans and Corporate Development
Kynexis (搜索) stated its intention to expand KYN-5356 development into Alzheimer's disease (搜索), though no clinical trial in that indication has been initiated. The company recently appointed Neil Swami, an experienced corporate development executive, as Chief Business Officer, and added John McDonald, former Head of M&A at Novo and current Operating Partner of Business Development and M&A at Forbion (搜索), as an advisor. These appointments are intended to strengthen corporate development capabilities ahead of what the company described as a late-stage cognition platform build-out.