Novadip Biosciences has secured €10.4 million in convertible financing to complete a pivotal Phase 3 trial of its lead cell therapy for a rare bone disorder.

Funding supports final-stage development

The financing, led by US-based New Science Ventures with support from Novadip’s existing investors, brings the company’s convertible financing raised since June 2025 to €20 million.

Novadip will use the latest funding to advance NVD003, an autologous cell-based therapy being developed for congenital pseudarthrosis of the tibia (CPT), a rare paediatric condition in which the tibia fails to heal properly.

The pivotal Phase 3 trial is currently under way in the US and Europe. The new funding will support completion of the study and preparation of a US Biologics License Application (BLA).

Novadip said the financing also enables it to access the final tranche of an €18 million venture debt facility agreed with the European Investment Bank in 2023, supported by the European Union’s InvestEU initiative.

Together, the financing provides additional funding for the company’s clinical and regulatory programme as NVD003 moves towards potential approval.

NVD003 enters late-stage development

NVD003 is an autologous cell therapy designed for patients with CPT, for whom treatment options can be limited.

Novadip is targeting market authorisation for NVD003 in CPT by 2028. The company is also preparing a separate Phase 3 programme in adults with critical size bone defects, with study start-up activities under way.

If approved in the US for CPT, NVD003 could also qualify for a Rare Pediatric Disease Priority Review Voucher from the US Food and Drug Administration, subject to the relevant regulatory requirements.

Novadip CEO and founder Denis Dufrane said: “This is an important step forward for Novadip. It provides the resources to advance NVD003 through several major clinical and regulatory milestones, including the completion of our pivotal Phase 3 program in congenital pseudarthrosis of the tibia and the preparation for regulatory submission in the United States.”

The company said the financing would allow it to remain focused on the ongoing Phase 3 programme and regulatory preparation.

Wider regenerative medicine pipeline

Novadip is also developing NVDX3, an allogeneic bone grafting material. Phase 1b/2a studies of NVDX3 have been completed in trauma surgery and lumbar intervertebral spine fusion.

The company has received FDA approval to begin a Phase 2b/3 investigational new drug trial for the programme.

The latest financing therefore comes as Novadip moves several programmes towards later-stage clinical development, with NVD003 currently the most advanced.

The company said its immediate priorities include completing the pivotal Phase 3 trial in CPT and preparing the US regulatory submission.