Valion Bio (VIBO) Emerging Growth Conference 91 summary

Strategic focus and pipeline overview

• Emphasis on late-stage, de-risked biopharma assets targeting immune therapies for improved patient survival.

• Pipeline includes lead indications in Acute Radiation Syndrome (ARS) and neutropenia, with ARS preparing for BLA submission and neutropenia ready for phase II.

• Platform technology (TLR5) enables applications in immuno-oncology, supportive cancer care, and ARS.

• Over 60 patents pending and significant investment in the TLR5 platform, with productive meetings with BARDA and other government agencies.

• Multiple additional indications planned for future development.

Clinical data and therapeutic potential

• Phase II study at Mayo Clinic showed reversal of immunosenescence in elderly patients using Entolimod.

• TLR5 agonists demonstrated direct tumor regression via NK and T cell activation, supporting immuno-oncology applications.

• Entolimod targets neutropenia, cachexia, and thrombocytopenia, addressing major side effects of chemo/radiation in cancer patients.

• Phase III pivotal studies completed for ARS; manufacturing validation ongoing for commercial launch.

• Drug supports neutrophil growth, bone marrow regeneration, and GI crypt preservation, improving quality and length of life for patients.

Regulatory and commercial outlook

• Manufacturing validation and bioequivalence studies underway for BLA submission, targeting late 2027 to early 2028 for approval.

• Recent acquisition of a commercial manufacturing organization in San Antonio to support in-house and third-party biologics production.

• Discussions with U.S. and international governments for use as a radiation countermeasure and potential inclusion in the Strategic National Stockpile.

• Agreement with NIAID to fund studies demonstrating GI and bone marrow protection, supporting stockpile candidacy.

• Anticipated high-value inflection points over the next 18-24 months.