MONT SAINT-GUIBERT, Belgium–(BUSINESS WIRE)–Novadip Biosciences (“Novadip” or “the Company”), a clinical-stage biopharmaceutical company developing a new class of regenerative tissue products to accelerate healing of large bone defects and injuries in a single treatment, today announced that it has raised an additional EUR 40 million in a Series B equity round and non-dilutive funding. The funding will accelerate the clinical development of two of Novadip’s investigational adipose stem cell (ASC)-derived tissue regeneration products: NVD-X3, an allogeneic therapeutic that can provide accelerated, durable bone union in spinal fusion procedures and non-healing fractures, and NVD-003, an autologous bone engraftment product designed to provide a single treatment cure for patients with critical size bone defects such as congenital pseudoarthrosis of the tibia (CPT).
The EUR 40 million financing is comprised of EUR 24 million in new equity and EUR 16 million in non-dilutive financing mainly by the Walloon Region. CR-CP Life Science Fund (China) joined existing investors, including New Science Ventures (US), Fund+, SRIW Life Sciences, VIVES Louvain Technology Fund, InvestSud, family offices and private investors, such as Pierre Drion and Olivier van der Rest, to support the equity round.
“This financing milestone is a recognition by our committed group of existing investors of the clinical benefits and broad market opportunities provided by our 3M³ tissue regeneration technology platform,” said Denis Dufrane, MD, PhD, CEO and Co-founder of Novadip Biosciences. “With this funding we will advance a new class of therapeutics that offer curative hope for patients suffering from large bone defects and enable accelerated healing of common orthopedic conditions such as radius fracture, spinal fusion.”
Novadip’s 3M³ platform is a 3-dimensional, extracellular matrix that utilizes adipose-derived stem cells to deliver highly specific growth factors and miRNAs to mimic the physiology of natural tissue healing. The platform supports three distinct therapeutic programs:
- 3MAUTO: autologous ASC products that provide one-time curative treatment to achieve long-term union and stability of critical size bone defects
- 3MALLO: “off-the-shelf” allogeneic matrix products to provide accelerated, stable bone union in 90 percent of bone engraftment procedures – a $7 billion addressable market, and
- 3MEXO: allogeneic exosome products that can repair tissue following surgical resection of solid tumors, such as osteosarcoma, melanoma, glioblastoma.
“We welcome the expanded support of our international investors, all of whom appreciate the immense potential of the 3M3 technology platform to deliver best-in-class tissue regeneration products that disrupt the standard of care in the US, EU and Asia,” said Eric P. Pâques, PhD, Chairman of the Novadip Biosciences Board of Directors. “We have been enormously impressed with the progress the Novadip team has achieved in advancing the 3MAUTO and 3MALLO programs into clinical studies. Looking ahead, it is clear that Novadip’s therapeutic programs can be hugely important for patients, and we look forward to supporting these dedicated individuals as they work to cultivate the clinical promise of the 3M3 technology platform across multiple high opportunity markets.”
About NVD-X3 for Spinal Fusion and Bone Non-Union Applications
The risk of bone non-union following fracture is greater than 50% across all bones due to fracture severity, co-morbidities (diabetes, obesity, smoking and other conditions) and medication use1. Additionally, more than 600,000 spine fusion procedures are performed annually. Together, these indications represent a peak sales opportunity for Novadip of $2.2 billion.
Novadip’s lead allogeneic product, NVD-X3, employs a matrix containing multiple bioactive factors that induce accelerated tissue healing. Designed as an “off-the-shelf” product, NVD-X3 can be shipped and stored at room temperature and offers superior intraoperative handling characteristics. A favorable COGS profile supports broad distribution and expanded patient access. Preclinical studies demonstrate that NVD-X3 offers superior bioactivity without the undesirable bone formation/resorption and inflammation observed with currently marketed bone engraftment products. Novadip plans to initiate a Phase 1/2 clinical trial for NVD-X3 in spine fusion and bone non-union procedures in Europe by the end of 2022.
About NVD-003 and CPT
Congenital pseudarthrosis of the tibia (CPT) is a rare pediatric bone condition occurring in one in 150,000 births. Children with CPT endure a high disease burden, including frequent fractures, loss of mobility, and potential amputation. The current standard of care – surgery with autologous bone graft – is associated with poor long-term outcomes, including high risk of chronic pain, infection, blood loss requiring transfusion, and persistent risk of amputation.
Novadip is developing NVD-003, an autologous therapy derived from ASCs as a potential single treatment to save limbs and restore mobility in patients with CPT. The favorable safety profile and potential clinical utility of NVD-003 for promoting healthy and durable bone formation is supported by clinical data from more than 50 adult and pediatric patients with non-healing fractures of the lower limb, bone non-union (BNU), obtained in Phase 1b/2a clinical trials and compassionate use. The active cells in NVD-003 autologous graft helped achieve durable union in critical size bone fractures with up to 5 years follow-up data. These results de-risk the company’s clinical development program for CPT and support future discussions with drug regulatory agencies about the design of late-stage pivotal trials to support eventual product registration. Novadip will initiate a Phase 1b/2a clinical trials in CPT patients between two and eight years of age in the US and EU end of 2022. NVD-003 has received orphan drug and rare pediatric disease designations for accelerated approval from the US Food and Drug Administration (FDA). If NVD-003 is approved by the FDA, Novadip is eligible to receive a priority review voucher that could provide more than $100 million revenue.
About Novadip Biosciences
Novadip Biosciences is a clinical stage company developing best in class tissue regeneration therapies to elevate the standard of care for critical size bone defects, common orthopedic conditions, and cancer. Its unique 3M³ tissue regeneration technology platform has the potential to generate an array of product candidates to address hard and soft tissue reconstruction for patients with limited or no treatment options. Co-Founded in 2013 by Denis Dufrane, MD, PhD, Novadip is headquartered in Mont Saint-Guibert, Belgium. For more information, visit https://www.novadip.com/.
1 Zura et al. Epidemiology of Fracture Nonunion in 18 Human Bones. JAMA Surg. 2016;151(11):e162775. November 16, 2016