Valerio's Pivot: Biotech Bets on Preclinical Focus & Financial Rigor

VILLEJUIF, France – April 29, 2026 – Valerio Therapeutics has unveiled a profound strategic transformation, detailed in its 2025 annual results, that pivots the biotechnology firm away from costly clinical trials towards a leaner, preclinical-focused model. The company is banking its future on its proprietary technology platforms, the creation of a new subsidiary, and a regime of rigorous financial discipline designed to stabilize its operations and fuel future growth in targeted therapies.

The announcement marks the culmination of a challenging year that forced the French biotech to fundamentally rethink its path forward. After facing financing difficulties and a temporary trading suspension in 2025, Valerio is emerging with a clarified strategy it believes will unlock the value of its core science.

A Turnaround Built on Restructuring

The 2025 financial report paints a stark picture of a company in transition. Operating expenses were slashed dramatically to €4.8 million, a steep decline from €18.3 million in the prior year. This drastic reduction was the direct result of a strategic decision to halt all clinical activities, including its VIO-01 trial, and shutter its U.S. office in Lexington, Massachusetts. The move concentrates all resources on early-stage research and development in France.

"2025 was a year of profound transformation for Valerio Therapeutics," said Julien Miara, Chief Executive Officer. "We clarified our strategic direction, strengthened our scientific foundations and continued to validate our technology platforms. The Company’s strategy is built around three pillars: internal programs, partnerships/licensing, and the creation of subsidiaries."

This strategic refocus was not just a choice but a necessity. In mid-2025, Euronext Growth had sanctioned the company and temporarily suspended trading of its shares due to delays in publishing its 2024 annual report, stemming from difficulties with its U.S. subsidiary's accounting records. The company has since resolved these issues, resuming trading and reinforcing its financial controls.

Despite the operational overhaul, revenues saw a healthy increase, climbing to €2.6 million in 2025 from €1.8 million in 2024. This income was primarily generated from existing license royalties and new partnership agreements, underscoring the early success of its new partnership-centric model.

Forging New Scientific Frontiers

At the heart of Valerio's new strategy are its two core technology platforms: V-Body and an integrated chemistry platform. The company is positioning itself as a specialist in extrahepatic oligonucleotide delivery—a challenging but highly valuable field in modern therapeutics.

The V-Body platform utilizes fully synthetic single-domain antibodies (sdAbs), which are ultra-small biologics engineered for deep tissue penetration and highly precise targeting. These sdAbs, derived from human antibody libraries, are about one-tenth the size of conventional antibodies, allowing them to access targets previously considered unreachable. The company aims to leverage this platform to move new drug candidates from discovery to first-in-human trial readiness in under two years.

Complementing this is an integrated chemistry platform focused on next-generation linkers and payloads, enabling the creation of customized immunoconjugates with optimized drug release at the target site.

This scientific refocus is most clearly embodied in the creation of InVimmune, Valerio's first subsidiary. Dedicated to the burgeoning field of in vivo cell therapy, InVimmune represents a major new growth pillar. Miara noted that the subsidiary "opens up highly attractive opportunities in indications with significant unmet medical needs." This move allows Valerio to pursue high-risk, high-reward science within a separate entity, potentially attracting specialized investors and partners while shielding the parent company.

Rebuilding Financial Foundations

Stabilizing the company's finances has been a top priority. As of December 31, 2025, cash and cash equivalents stood at €1.0 million. While modest, this figure is supported by a series of decisive financial maneuvers.

Throughout 2025, Valerio secured its immediate future by extending the maturity of its bank debt and renegotiating payment schedules with key suppliers. Crucially, the company received the backing of its principal shareholders, Artal International Inc. and Financière de la Montagne, who provided €5.5 million in advances to support operations. This was followed by a successful capital increase of €6.36 million in October 2025, demonstrating continued investor confidence in the new leadership and strategy.

These measures provide the financial flexibility needed to execute the company's ambitious R&D plans while maintaining strict cost discipline. The company has stated its financial visibility is further supported by anticipated revenues from existing and future partnerships.

A New Home and New Leadership

Valerio's transformation is also physical and organizational. In March 2026, the company relocated its offices and laboratories to The Hive within the Paris-Saclay Cancer Cluster (PSCC) in Villejuif. This strategic move embeds Valerio within one of Europe's leading oncology innovation ecosystems, providing access to state-of-the-art facilities and fostering collaboration with academic, clinical, and industry peers.

The leadership team steering this new course is also relatively new. Julien Miara took the helm as CEO in late 2024, tasked with navigating the company through its restructuring. The board has also been significantly strengthened with scientific expertise. In late 2025, Dr. Antonin (Tony) de Fougerolles, a veteran of the biotech industry who was instrumental in developing platforms at Moderna and Ablynx, joined the Board of Directors. His deep experience in RNA and antibody therapeutics directly aligns with Valerio's renewed scientific focus.

With a leaner structure, a clear preclinical focus, and a fortified balance sheet, Valerio Therapeutics is positioning itself for a new phase of growth. The company's 2026 agenda is packed with key objectives, including advancing its proprietary platforms, accelerating the scale-up of InVimmune, and expanding its base of revenue-generating partnerships. The path ahead requires rigorous execution, but the foundation for a significant turnaround appears to be firmly in place.