PresentationUnknown Executive Thank you very much for taking your time. We would now like to begin oral presentation of highlight of E2086 from World Sleep 2025 oral presentation. This is a virtual session. Please check our website for presentation material. In Singapore this week, World Sleep 2025 was held. E2086 Phase I study results were presented in oral presentation. The highlight of the presentation will be given today, and questions will also be taken to deepen understanding of the audience of E2086. ...

Core Insights - The World Sleep 2025 conference took place in Singapore, where the Phase I study results of E2086 were presented [2] - Dr. Katsutoshi Ido, the Chief Scientific Officer, led the presentation and addressed audience questions to enhance understanding of E2086 [2] Group 1 - The presentation of E2086's Phase I study results was a highlight of the World Sleep 2025 event [2] - The session was conducted virtually, and additional presentation materials are available on the company's website [1]

Summary of E2086 Presentation at World Sleep 2025 Company and Industry - **Company**: Eisai Co., Ltd. - **Industry**: Pharmaceutical, specifically focusing on neurology and sleep disorders Core Points and Arguments 1. **Introduction of E2086**: E2086 is a selective orexin receptor two agonist developed to treat narcolepsy type one, addressing the underlying orexin deficiency rather than just symptomatic treatment [12][34] 2. **Mechanism of Action**: E2086 acts on the orexin system in the brain, promoting wakefulness by stimulating orexin receptors, contrasting with Dayvigo (lemborexant), which is an orexin receptor antagonist [4][8] 3. **Clinical Trial Design**: The Phase 1b clinical trial was a multicenter, randomized, double-blind, five-period crossover study comparing E2086 at doses of 5, 10, and 25 mg against placebo and modafinil [14][20] 4. **Efficacy Results**: E2086 significantly extended sleep latency compared to placebo and modafinil across all doses tested, with effects lasting beyond seven hours post-administration [24][25][32] 5. **Safety Profile**: E2086 was generally well tolerated, with most treatment-emergent adverse events being mild to moderate, including increased urinary frequency, nausea, and dizziness [30][31] 6. **Future Development Plans**: Eisai plans to initiate Phase II studies for both narcolepsy type one and type two within the fiscal year, targeting submission for approval by fiscal 2028 [34] Additional Important Content 1. **Unique Development Approach**: Eisai has a unique position in developing both agonists and antagonists for the orexin system, which is not common in the industry [11] 2. **Comparison with Competitors**: The presentation highlighted the competitive landscape, noting that while Takeda is ahead in development, Eisai's once-daily dosing and safety profile could differentiate E2086 in the market [46][57] 3. **Potential for Broader Applications**: The company is considering expanding indications beyond narcolepsy to include idiopathic hypersomnia and other neurodegenerative diseases based on the orexin platform [75] 4. **Regulatory Considerations**: There are no current concerns regarding the scheduling of E2086 as a controlled substance, but ongoing studies will assess any potential for addictive properties [92][95] This summary encapsulates the key findings and strategic directions discussed during the presentation, emphasizing the innovative approach of Eisai in addressing sleep disorders through E2086.

Eisai's Strengths in Orexin Platform Highlight of E2086 Oral Presentation at World Sleep 2025 September 11, 2025 Eisai Co., Ltd. Katsutoshi Ido, Ph.D. Chief Scientific Officer Orexin: A Key Regulator of Sleep-Wakefulness Orexin receptor antagonist Dayvigo Orexin Sleep Center Arousal Center Suppression Dayvigo Suppressing excessive orexin signaling at night Inhibition Sleep Orexin receptor agonist E2086 2 Sleep Center Arousal Center Orexin Suppression E2086 Enhancement of daytime orexin signaling Enhancement ...

Core Insights - Eisai Co., Ltd. will present clinical data on the selective orexin 2 receptor agonist E2086 and the orexin receptor antagonist lemborexant (DAYVIGO®) at the World Sleep Congress in Singapore from September 5 to 10, 2025 [1][2] Group 1: Presentations and Studies - Key presentations include results from the Phase Ib clinical study of E2086 for narcolepsy type 1 and the Phase IV SELENADE Study on lemborexant's effects in patients with insomnia and depressive episodes [2] - The company will host a symposium to introduce the latest evidence on lemborexant in Asia [2] Group 2: Focus Areas - Eisai focuses on neurology, particularly sleep disorders like insomnia and narcolepsy, aiming to create innovative products for high unmet medical needs [3] - The company seeks to enhance the quality of life for individuals with neurological diseases and their families [3] Group 3: Presentation Schedule - Oral presentations will include E2086's effects on wakefulness in narcolepsy type 1 on September 8 [4] - Multiple poster presentations on lemborexant will cover various studies, including its safety and efficacy in different populations and conditions [4][5] Group 4: Product Information - Lemborexant (DAYVIGO) is an orexin receptor antagonist approved in over 25 countries, designed to improve sleep onset and maintenance with minimal residual effects [7] - E2086 is a novel selective orexin 2 receptor agonist that has shown potential in increasing wakefulness and reducing cataplexy in nonclinical studies [8]