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Valion Bio Reports First Quarter 2026 Financial Results

SAN ANTONIO, May 14, 2026 – Valion Bio, Inc., previously known as Tivic Health Systems, Inc., has reported its financial results for the first quarter of 2026. This marks a significant milestone as it reflects the company’s progress under its new corporate identity and strategic direction. As a clinical-stage immunotherapeutics company, Valion Bio aims to advance its Entolimod platform and broaden its collaborations with government agencies.

Major Developments in Q1 2026

The first quarter of 2026 was pivotal for Valion Bio, characterized by various milestones:

• - Corporate Transformation: The company successfully transitioned its name and Nasdaq listing symbol from Tivic Health Systems (TIVC) to Valion Bio (VBIO). This shift consolidates Valion's commitment to focusing on immunotherapeutics.
• - Government Engagement: Valion furthered its discussions with U.S. government entities, including BARDA and the NIAID, about developing Entolimod as a countermeasure for Acute Radiation Syndrome (ARS). The focus is on procurement and stockpiling strategies to meet national preparedness needs.
• - Integration of Velocity Bioworks: Progress continues in fully integrating Velocity Bioworks, the company's recent acquisition, enhancing its manufacturing capabilities and operational efficiency. This consolidation allows Valion to streamlining its production processes while fostering a separate revenue stream through their contract development and manufacturing offerings.

Valion’s CEO Michael K. Handley emphasized, “The transition to Valion Bio embodies our evolved identity as a clinical-stage immunotherapeutics company. Our primary focus has shifted to develop therapies centered on our TLR5 platform, enhance our biomanufacturing capabilities, and engage with federal health agencies for preparedness initiatives.”

Focus on Entolimod

Valion’s lead candidate, Entolimod (CBLB502), is designed to activate specific immune pathways to provide cytoprotection and modulate responses in radiological contexts. The compound has shown favorable results in non-human primate studies, demonstrating potential improvements in tissue recovery following radiation exposure. With the FDA's Animal Rule designation, Entolimod benefits from the Fast Track and Orphan Drug recognitions, underscoring its significant therapeutic promise.

Financial Overview

Valion reported an operating expense of $5.6 million for the first quarter, a substantial increase compared to $1.4 million during the same period the previous year. This rise can be attributed to the integration costs associated with Velocity Bioworks and ongoing developmental efforts for Entolimod.

Despite a net loss of $6.2 million, or $2.23 per share, the company retains a strong cash position with $7.2 million in cash and equivalents, highlighting its capacity for future investments and R&D initiatives. The ongoing evaluation of capital alternatives demonstrates Valion’s strategic planning to meet its operational and developmental goals.

Future Outlook

As 2026 progresses, Valion focuses on its path to commercialization for Entolimod and further development of its second-generation TLR5 agonist, Entolasta. This product is designed to address additional therapeutic needs, particularly in oncology supportive care, an area with substantial market potential. The integration of Velocity Bioworks is expected to reduce manufacturing costs and enhance the overall efficiency of Valion's drug pipeline.

In conclusion, the first quarter was not merely about introspection but execution. With their strategic integrative approach and governmental partnerships, Valion Bio paves the way for significant advancements in immunotherapeutic solutions. The company remains committed to maintaining visibility, broadening its engagement, and enhancing its operational efficacy as it navigates the remainder of 2026.

For more detailed financial results and business updates, Valion Bio invites stakeholders to join its upcoming conference call scheduled for later today, where further insights will be shared. The call can be accessed via this link or by dialing in using the provided access numbers.

About Valion Bio

Valion Bio is dedicated to pioneering advancements in immunotherapy, emphasizing research and development tailored for diverse healthcare applications. With its unique manufacturing capabilities through Velocity Bioworks, Valion is well-positioned to enhance the landscape of clinical-stage immunotherapeutics.

For more information, visit Valion Bio's official website.