Core Business and Focus

The company???s core mission is the discovery, development, and commercialization of novel specialty medicines to address areas of high unmet medical need globally, particularly in Japan. The business model is an integrated approach, leveraging proprietary drug discovery technology to generate a robust internal pipeline and securing major partnerships with leading global pharmaceutical companies for clinical development and commercialization.

Proprietary Technology: NxWave??? (formerly StaR® Technology)

The central pillar of Nxera Pharma???s (formerly Sosei Heptares) drug discovery effort is its industry-leading platform focused on G protein-coupled receptors (GPCRs). GPCRs are a large superfamily of cell surface receptors that are integral to numerous biological functions and are therefore vital drug targets, linked to a wide array of human diseases. Historically, many GPCRs have been considered 'undruggable' due to technical challenges in obtaining stable and high-resolution structures.

The company???s NxWave??? platform, which incorporates the foundational Stabilised Receptor (StaR®) technology and Structure-Based Drug Design (SBDD) capabilities, overcomes these challenges. * StaR® Technology: This proprietary method allows for the stabilization of GPCRs in specific conformations. This is crucial as it enables the company to determine high-resolution crystal structures of the receptors. * Structure-Based Drug Design (SBDD): By having a clear 3D structure of the target GPCR, researchers can rationally design small molecule or biologic drug candidates with high precision, selectivity, and potency. This capability is applied to create best-in-class or first-in-class drug candidates.

Products and Services (Drug Portfolio)

Nxera Pharma's offerings can be broadly categorized into commercial products in Japan and an extensive internal and partnered pipeline.

Commercialized Products in Japan

The company has a portfolio of commercialized pharmaceutical products, primarily in Japan, which provides a stable revenue stream. These include: * PIVLAZ (Clazosentan): Used for cerebral vasospasm. * Oravi (Miconazole): Used for oral candidiasis. * Respiratory products licensed from Novartis, which include: * Ultibro (Indacaterol/Glycopyrronium): A long-acting bronchodilator for COPD. * Breezhaler (Indacaterol): A long-acting beta-agonist for COPD. * Seebr (Glycopyrronium): A long-acting muscarinic antagonist for COPD. * Enerzair (Indacaterol/Glycopyrronium/Mometasone): A combination treatment for asthma. * QUVIVIQ (Daridorexant): A dual orexin receptor antagonist for insomnia, marketed in Japan through a partnership.

Drug Discovery and Development Pipeline

The company maintains a deep and diverse pipeline of over 30 active programs spanning from discovery to late-stage clinical trials, both internally and through collaborations. The therapeutic focus areas include:

• Neurology: Targeting central nervous system disorders such as Alzheimer's disease, schizophrenia, and other neurodegenerative conditions. Specific programs include Muscarinic M4 Agonists and Muscarinic M1 Agonists.
• Gastrointestinal (GI) and Immunology: Addressing immune disorders and chronic inflammatory conditions like Inflammatory Bowel Disease (IBD). Programs include a collaboration with GSK on a portfolio of GPR35 agonists and a focus on the Gut-Brain Axis.
• Metabolic Disorders: Developing treatments for diseases such as diabetes. A multi-target collaboration with Eli Lilly is centered on GPCR targets associated with these conditions, and the pipeline includes a GLP-1 agonist.
• Rare Diseases: Pursuing treatments for conditions with limited options.

Strategic Partnerships

A key element of the company's service model is its robust framework for strategic collaboration, where it acts as a global partner of choice for GPCR-focused drug discovery. The company leverages its platform to identify and create novel drug candidates and then partners with major pharmaceutical companies for late-stage development and global commercialization. Partners have included: * Pfizer: Multi-target drug discovery collaboration focused on up to ten GPCR targets across multiple therapeutic areas. * AstraZeneca * Genentech (Roche) * Novartis * Takeda Pharmaceutical Company * Eli Lilly and Company: Collaboration focused on GPCR targets associated with diabetes and metabolic diseases. * GSK: Global collaboration and license agreement targeting immune disorders of the digestive system with GPR35 agonists.

Through these alliances, Sosei/Nxera Pharma is eligible to receive upfront payments, research funding, development and commercial milestone payments totaling hundreds of millions of dollars, plus tiered royalties on the net sales of commercialized products.

In summary, the entity known formerly as Sosei Group Corporation (Sosei Co. Ltd.) is now Nxera Pharma Co., Ltd., a globally operating biopharmaceutical company. Its core activity is the discovery of novel therapeutics using its proprietary NxWave??? (StaR®/SBDD) platform to target difficult-to-drug GPCRs for indications in neurology, immunology, GI, and metabolic diseases. Its business is built on advancing an internal pipeline and securing significant partnerships to bring its drug candidates to market alongside its portfolio of commercialized products in Japan.