Valerio Shutters U.S. Operations, Cuts Clinical Work Due to ‘Financing Challenges’

Valerio only has cash to last three months, according to the DNA decoy specialist. The news comes less than six months after the company acquired Emglev Therapeutics to advance antibodies for autoimmune and inflammatory conditions, as well as cancers.

Paris-based Valerio Therapeutics announced on Tuesday that it will terminate all of its clinical studies and will wind down operations at its U.S. facility in Lexington, Massachusetts.

Valerio’s board launched the sweeping move “in the context of the financing challenges” that prompted the company to reduce expenses. Currently, Valerio has enough cash to last three months, according to Tuesday’s press announcement.

The company is also currently in talks with shareholders for additional financing that could buoy its cash trajectory for the next year.

One notable casualty of Tuesday’s clinical cuts is VIO-01, an investigational DNA decoy therapeutic that works by mimicking double-stranded DNA breaks in a tumor cell to trigger the cell’s repair mechanism. In turn, the DNA decoy sequesters this DNA repair machinery, preventing them from reaching the sites of actual DNA damage, ultimately leading to the death of cancer cells.

Before being discontinued, VIO-01 was undergoing proof-of-concept studies that would support an Investigational New Drug application in cancer as a monotherapy or with other agents.

Tuesday’s actions “will help consolidate the financial position of the company” and allow it to “focus on our core strengths in early-stage research while preserving financial flexibility to drive transformative innovation” CEO Julien Miara said in a statement. Valerio will provide more details about its new business direction as soon as discussions with stakeholders conclude.

With its clinical work now dropped, Valerio said it will focus on other early-stage activities, like its single-chain antibody portfolio to “open new avenues for the company,” according to Tuesday’s announcement. Valerio is also kicking off a strategic review of its business to “redefine” its pipeline and long-term vision.

Valerio got those single-chain antibodies when it acquired Emglev Therapeutics, which the biotech planned to leverage for autoimmune and inflammatory diseases, and cancers.

Valerio has been in the negative for some time now. In its half-year 2024 business report in September, the biotech reported €10.8 million ($11.21 million) in operating expenses and a net loss of €11 million ($11.41 million).

These represented slight improvements from the corresponding 2023 figures, but the biotech nevertheless reported at the time that it had €4 million ($4.17 million) on its balance sheet, which along with other credits and partnership earnings, as well as cost optimization efforts, gave Valerio “financial visibility” through the end of 2024.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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