Novadip secures €10.4 million financing to complete pivotal Phase 3 trial

Novadip Biosciences, a late-stage clinical biotechnology company specializing in regenerative medicine, has announced the completion of a funding round of €10.4 million ($11.98 million) in convertible financing. US-based New Science Ventures led this financing with the support of Novadip's other historic investors, a strong syndicate of leading life sciences and institutional investors, including Fund+, Wallonie Entreprendre, VIVES Fund, ORSA Tech, Sambrinvest, Noshaq and Invest.BW.

Adding to a previous €9.6 million convertible loan secured last year, this operation brings the convertible financing to a total of €20 million ($23.3 million).

Novadip will use the funding to advance its lead program, NVD003, an autologous cell-based therapy, through the final stage of clinical development and preparation for regulatory submission. The funds will support completion of a pivotal Phase 3 trial in congenital pseudarthrosis of the tibia (CPT), currently ongoing in the US and EU, as well as the preparation of the US Biologics License Application (BLA), while strengthening the company's path toward major value-creating milestones, including strategic partnerships and, upon BLA approval, the receipt of a Rare Pediatric Disease Priority Review Voucher (PRV) from the FDA.

The company's goal is to obtain market authorization for NVD003 for CPT by 2028 and for adults with critical size bone defects (CSBD) by 2031, with the aim of achieving multi-billion dollar peak sales worldwide.

Achieving the €10.4 million financing target also enables Novadip to access the last tranche of its €18 million venture debt financing agreement signed in 2023 with the European Investment Bank (EIB) with the support of the European Union's InvestEU initiative. Unlocking this loan tranche further reinforces the company's financial position as it pursues its regulatory, clinical and strategic objectives.

"This financing is a strong vote of confidence from our investors, and I'd like to thank them for their ongoing support," said Denis Dufrane, MD, PhD, CEO and founder of Novadip. "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. Most importantly, it allows us to remain fully focused on our mission of bringing transformative regenerative therapies to patients with limited treatment options, with the aim of becoming a leader in limb sparing treatment".

"With a pivotal Phase 3 program underway, regulatory preparation advancing and a significant commercial opportunity, Novadip is entering a critical value-creating period," said Eric Pâques, Chairman of the Board. "This financing provides the means to execute on these priorities and prepare the business for its next stage of development."

Novadip is currently entering a new stage of development as it advances its innovative therapies toward commercialization: its lead product NVD003, an autologous cell-based therapy, is currently in a Phase 3 trial in the US and the EU for congenital pseudarthrosis of the tibia, a rare pediatric condition for which treatment is difficult. Study start-up activities are also underway for a Phase 3 clinical trial in adults with critical size bone defects. For its other product NVDX3, an allogenic bone grafting material, Phase 1b/2a trials have now been completed in trauma surgery and lumbar intervertebral spine fusion, with approval secured from the FDA to start a Phase 2b/3 IND (Investigational New Drug) trial.

About the investors:
New Science Ventures - https://www.newscienceventures.com
Fund+ - https://fundplus.be
VIVES Fund - https://www.vivesfund.com/en
Wallonie Entreprendre - https://www.wallonie-entreprendre.be/en/
ORSA Tech - https://orsafund.be/
Sambrinvest - https://www.sambrinvest.be/fr/
Noshaq - https://noshaq.be/en/
Invest.BW - https://investbw.be

About Novadip Biosciences
Novadip is a late-stage clinical biotech company aiming at advancing the standard of care for patients undergoing bone and issue regenerative treatment. Based on the scientific discoveries of founder Prof. Dr. Denis Dufrane, MD, PhD, and research from UCLouvain and St. Luc University Hospital, the company is developing its unique 3M³ tissue regeneration technology platform, designed to create a new class of regenerative tissue products that accelerate the healing of large bone defects, bone nonunion and spine fusion in a single treatment, for patients with limited or no treatment options.

Novadip's pipeline includes two lead products: NVD003, an autologous cell-based therapy currently in a Phase 3 trial for congenital pseudarthrosis of the tibia (CPT) in the US and EU, and about to start Phase 3 clinical trials in adults with critical size bone defects; and NVDX3, an allogenic bone grafting material for which Phase 1b/2a trials in trauma surgery and lumbar intervertebral spine fusion have been completed. The FDA has granted approval to start a Phase 2b/3 IND (Investigational New Drug) trial with NVDX3.

Founded in 2013 in Belgium, Novadip has 53 team members. Since inception, it has raised €137 million in equity and non-dilutive funding, including financing from the European Investment Bank.

Media and analysts contacts
Andrew Lloyd & Associates
Celine Gonzalez - Lorraine Walters
US: +1 203 724 5950 - UK: +44 1273 952 481
Novadip contacts
Denis Dufrane, CEO
Soumya Chandramouli, CFO
Tel: + 32 10 779 220 - [email protected]