In its first full quarter under the Valion Bio identity, the company completed its legal name change and Nasdaq symbol update while reporting operating expenses of $5.6 M versus $1.4 M a year ago. The increase reflects the December acquisition of Velocity Bioworks, ongoing Entolimod development costs and one-time rebranding charges, leading to a net loss of $6.2 M ($2.23/share) and cash reserves of $7.2 M as of March 31.

Entolimod progressed toward approval under the FDA’s Animal Rule, backed by Fast Track and Orphan Drug designations and a demonstrated 200-fold scale-up at 50-liter fermentation equivalent to ~1.3 million human doses. Engagements expanded with BARDA, NIAID and the Department of War to explore procurement and stockpiling as a medical countermeasure for Acute Radiation Syndrome.

The fully owned CDMO subsidiary Velocity Bioworks advanced integration at its San Antonio facility, supporting in-house Entolimod production and initiating business development discussions with third-party biotech clients. This domestic biologics capacity addresses underserved Phase I and II manufacturing needs, positioning Velocity as both a cost accelerant for Valion Bio’s pipeline and a potential standalone revenue generator.

Valion Bio’s next-generation TLR5 agonist, Entolasta, continued preclinical progress toward oncology supportive care, longevity and immunosenescence applications. Management highlights neutropenia in chemotherapy and radiation patients as a high-value initial market, leveraging Entolasta’s mechanistic differentiation and Velocity’s streamlined manufacturing to accelerate clinical timelines.