Valion Bio Inc（VBIO）資訊與事件VBIOValion Bio Inc

Valion Bio Announces Final Data on Entolimod Safety Study

Valion Bio announced final data from a National Institute of Allergy and Infectious Diseases, NIAID/Radiation and Nuclear Countermeasures Program, RNCP,-funded safety study of its lead biologic drug candidate, Entolimod, which is designed to protect and mitigate both hematopoietic and gastrointestinal, GI, forms of acute radiation syndrome, ARS. "These positive safety findings represent an important de-risking milestone in the ongoing development of Entolimod as a potential medical countermeasure for ARS, a life-threatening condition with severe unmet medical needs," said Dean Zikria, Interim Chief Executive Officer of Valion Bio. "With this phase complete, the program is positioned to move into a fully funded AFRRI therapeutic study focused on survival and GI tissue recovery following radiation exposure."

Valion Bio Receives Acquisition Inquiries, Evaluates Strategic Options

Valion Bio has received unsolicited acquisition inquiries from independent third parties concerning its wholly owned contract development and manufacturing organization, Velocity Bioworks. The Company has entered into preliminary discussions with these interested parties while continuing to evaluate a range of strategic options for Velocity. These discussions are consistent with the strategic priorities outlined in Valion's October 21 announcement, including advancing its lead biologic drug candidate, Entolimod, and other pipeline assets, building Velocity's commercial business, and evaluating strategic opportunities for the CDMO subsidiary. Velocity provides U.S.-based biologics development and manufacturing capabilities that support Valion's internal pipeline and are available to biotechnology companies advancing early-phase programs. Alongside these discussions, Valion continues to operate the subsidiary and pursue new customer relationships. Valion has retained a nationally recognized investment banking firm to serve as financial advisor to its Board of Directors in evaluating a potential transaction. Management and the Board will consider the proposed valuation and terms, execution certainty, and potential net proceeds. In evaluating any potential transaction, a key priority for Valion will be retaining production rights and securing continued manufacturing capabilities for Entolimod and potentially other assets in the Company's development pipeline. Depending on its structure, a sale could provide additional capital for Entolimod's ongoing development and other corporate priorities while positioning Velocity for growth under new ownership. Discussions remain preliminary, and Valion has not committed to a sale or any other specific transaction. There can be no assurance that these discussions will lead to a definitive agreement or a completed transaction on acceptable terms, or at all. The Company continues to evaluate the full range of strategic opportunities for Velocity and does not expect to provide further updates unless a definitive agreement is reached, or the Board determines that disclosure is appropriate or legally required.

Valion Bio's New CEO Outlines Three Key Priorities

Valion Bio shared the initial findings and priorities from Dean Zikria's first 30 days as Interim CEO. Mr. Zikria's strategic review has set a focused agenda built on three priorities: Advancing the development of Entolimod and other pipeline assets; Pursuing customer and revenue capabilities for Velocity Bioworks, the Company's wholly owned contract development and manufacturing organization; and Evaluating strategic partnerships, co-investment structures, licensing deals, and/or other transactions for Velocity that could unlock additional value from the CDMO. "Having served on Valion's Board of Directors for more than seven years, I have a deep understanding of the Company's science, assets, and people, and I believe those factors provide a meaningful foundation for future success," said Mr. Zikria. "It is also clear to me there has been a significant and persistent gap between these and how the stock market has seen and valued our Company. My initial review has reinforced the importance of translating our underlying strengths into measurable development progress, commercial traction, and disciplined capital allocation. Our focus is on advancing the opportunities with the greatest potential to create value for shareholders, while remaining pragmatic about how we fund, develop, and commercialize our assets."