Core Insights - Nxera Pharma will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals due to the initiation of clinical development of ORX142, a novel orexin receptor 2 (OX2R) agonist [1][2] - The milestone payments include US$1.8 million recognized as revenue in Q2 2025 and US$3.0 million in Q3 2025 [2] Company Overview - Nxera Pharma is a technology-driven biopharma company focused on developing specialty medicines for unmet medical needs in Japan and globally [3] - The company has established a commercial business in Japan to develop and market innovative medicines, addressing a growing market in the APAC region [3] Pipeline and Development - Nxera Pharma has an extensive pipeline of over 30 active programs, utilizing its NxWave™ discovery platform, targeting major unmet needs in neurology, metabolic diseases, and immunology [4] - The pipeline includes potentially first- and best-in-class candidates, advancing from discovery to late clinical stages in collaboration with leading pharmaceutical and biotech companies [4] Workforce and Locations - Nxera employs approximately 400 people across key locations including Tokyo, Osaka, London, Cambridge, Basel, and Seoul [5]

DISCLAIMER AND FORWARD LOOKING STATEMENTS This presentation has been prepared by Centessa Pharmaceuticals plc (the "Company") for informational purposes only and not for any other purpose. This presentation does not contain all the information that is or may be material to investors or potential investors and should not be considered as advice or a recommendation to investors or potential investors in respect of the holding, purchasing or selling of securities or other financial instruments and does not tak ...

BOSTON and LONDON, June 16, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND to initiate a Phase 1 clinical study of ORX142 in healthy volunteers. ORX142 is an investigational, novel, highly potent and selective OX2R agonist being developed for the treatment of select neurological and neurodegenerative disorders. ORX142 is the second drug candidate from the Compa ...

Summary of Centessa Pharmaceuticals (CNTA) Conference Call Company Overview - **Company**: Centessa Pharmaceuticals (CNTA) - **Focus**: Orexin program, specifically ORX750, an orexin agonist for treating narcolepsy and idiopathic hypersomnia Key Insights on Orexin Space - **Exciting Year Ahead**: Centessa anticipates a data-rich year with multiple catalyst events, including Phase II data disclosures for narcolepsy type one, type two, and idiopathic hypersomnia with ORX750, which is considered the most potent and selective orexin agonist in clinical development [2][4] - **First in Class Opportunity**: The company aims for a first-in-class opportunity in narcolepsy type two and idiopathic hypersomnia, with a best-in-class profile characterized by rapid onset of action, potential for QT dosing, linear pharmacokinetics (PK), and flexible dosing [2][4] Phase II Study Design - **Innovative Design**: The Phase II study allows for dose selection during the study based on real-time data, enabling optimal dosing and flexibility for patients [2][3] - **Efficacy Data**: Preliminary data from sleep-deprived healthy volunteers showed significant efficacy, with patients on ORX750 maintaining wakefulness significantly longer than those on placebo [7][8] Safety and Tolerability - **High Tolerability**: The drug class is reported to be extremely well tolerated, with minimal on-target adverse events (AEs) such as insomnia and polyuria [15][16] - **Liver Toxicity Concerns**: Centessa emphasizes that liver toxicity is molecule-specific and not an on-target effect, focusing on developing molecules with a favorable metabolic profile to mitigate risks [20] Market Opportunity - **Large Patient Population**: The company has revised epidemiological numbers, identifying approximately 50,000 diagnosed and treated narcolepsy type one patients, 100,000 in type two, and 120,000 in idiopathic hypersomnia, indicating a substantial market opportunity [24][25] - **Potential for Multiple Agonists**: There is potential for more than one orexin agonist in the market, given the large patient population and unmet clinical needs [25] Future Directions - **Expansion into Other Indications**: Centessa plans to explore orexin agonists in neurodegenerative and psychiatric disorders, such as Parkinson's disease and major depressive disorder, where excessive daytime sleepiness is prevalent [36][37] - **Partnership Opportunities**: While currently fully financed to execute clinical development plans, the company remains open to partnerships for indication expansion in the future [38] Conclusion - **Transformational Potential**: The orexin agonist class, particularly ORX750, is positioned to significantly impact the treatment landscape for narcolepsy and other disorders characterized by excessive daytime sleepiness, with a strong focus on patient needs and flexible dosing strategies [36][37]