Nxera Pharma to Regain Full Rights to GPR52 Agonist Program for Schizophrenia

Tokyo, Japan and Cambridge, UK, 19 December 2025 – Nxera Pharma Co. Ltd (“Nxera” or “the Company; TSE 4565) today announces that Boehringer Ingelheim has informed the Company of its decision not to exercise its exclusive option to license Nxera’s GPR52 agonist program for schizophrenia, including the Phase 2 ready lead compound NXE0048149 (“NXE’149”). No further information was provided by Boehringer Ingelheim. All rights to the GPR52 portfolio will revert in full to Nxera Pharma together with all data and intellectual property generated under the collaboration in accordance with the terms of the Collaboration and License Option Agreement.

NXE’149 and other GPR52 agonists within the portfolio were designed by Nxera using its world-leading NxWave™ structure-based drug design platform to improve patient outcomes by simultaneously addressing positive, negative, and cognitive symptoms of schizophrenia.

A Phase 1 trial evaluating single and multiple ascending doses of NXE’149 demonstrated a highly favourable safety profile, with NXE’149 well tolerated in healthy participants across all dose levels. There were no severe or serious adverse events (AEs) and no AEs leading to discontinuation. Pharmacokinetic analyses showed dose-proportional exposure, equivalent free concentrations in plasma and cerebrospinal fluid at steady state, and a long half-life supporting once-daily dosing. Notably, pharmacodynamic endpoints including cognitive assessments, neurophysiological measures and peripheral biomarkers provided evidence of engagement of brain circuitry relevant to the treatment of schizophrenia and related disorders.

The expression of GPR52 in brain regions associated with positive symptoms of schizophrenia (e.g. hallucinations and delusions) and those associated with cognitive dysfunction (e.g. attention and memory deficits) and negative symptoms (e.g. social withdrawal and apathy), suggest that NXE’149 may have the potential to treat all three symptom domains of schizophrenia, unlike current therapies which only treat the positive symptoms. The benefit risk profile of NXE’149, as evidenced by the preclinical and human pharmacodynamic data, could offer patients a major new therapeutic option for their disease and support its continued clinical development.

With the program now Phase 2 ready, Nxera plans to explore strategic opportunities, including a formal out-licensing process with the intention of partnering the program with a major pharmaceutical or specialist neuroscience company in 2026.

The event reported today has no impact on Nxera’s consolidated financial results for the current accounting period. If any matters requiring disclosure are identified, the Company will announce these promptly.

Christopher Cargill, CEO and President of Nxera Pharma, commented: “Although we are disappointed that Boehringer Ingelheim has chosen not to proceed with the license option, its decision does not diminish the significant potential of the GPR52 agonist program, which has demonstrated highly encouraging attributes as a first-in-class approach to treating several major symptoms of schizophrenia and address the shortcomings of current treatment options.

“We are energised by the strong scientific and clinical foundations already established and see meaningful opportunity in regaining full rights. We look forward to updating the market as we advance discussions with potential partners next year.”

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About Nxera Pharma

Nxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.

We have built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high value, large and growing market and those in the broader APAC region.

Behind that, and powered by our unique NxWave™ discovery platform, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline of potentially first- and best-in-class candidates is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across obesity and metabolic disorders, neurology/neuropsychiatry and immunology and inflammation.

Nxera employs approximately 400 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).

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Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.