Core Viewpoint - Virax Biolabs Group Limited is focused on advancing its innovative T-cell diagnostics and immune profiling solutions, with strategic goals set for 2025 to enhance its market presence and address chronic inflammation and immune dysfunction [2][3][4]. Company Developments - In 2024, Virax launched ImmuneSelect, a research-use-only version of its ViraxImmune™ platform, aimed at researchers and clinicians [3][9]. - The company initiated a clinical study in the UK to assess the performance of the ViraxImmune™ platform in detecting T-cell dysfunction in post-acute infection syndrome patients, with an enrollment of up to 160 participants [6]. - Discussions have begun with U.S. clinical institutions to support IVD development, and a request for a formal meeting with the FDA is planned for Q2 2025 [7][8]. Financial Highlights - Research and development expenses increased by approximately 33% year-over-year as of September 30, 2024, with capital expenditures also rising [15]. - The company reported a cash balance of approximately $7.3 million and working capital of approximately $6.6 million as of September 30, 2024, with no long-term debt obligations [16]. Strategic Goals for 2025 - Key priorities include advancing clinical validation studies in the UK and U.S., progressing U.S. regulatory interactions, expanding distribution channels for ImmuneSelect, and initiating a clinical performance study for protective immunity [13][14]. Distribution Agreements - Virax has established distribution agreements for its ImmuneSelect products across the EU, UK, Norway, and Switzerland, and aims to secure U.S. distribution partners by Q1 2025 [10][11]. - The company expanded its ViraxClear distribution channels, including agreements to supply Mpox Virus Real-Time PCR Detection Kits to multiple regions [12].
Virax Biolabs' CEO James Foster Issues Letter to Shareholders