Can you present Novadip, your pipeline, and the 3M3 tissue regeneration platform?

Novadip Biosciences is a clinical-stage biopharmaceutical company founded to design, develop, and bring to the market a new class of regenerative tissue products to accelerate the healing of large bone defects and injuries in a single treatment. We are committed to changing lives by providing innovative regenerative medicine solutions for patients with limited or no effective treatment options. Our team is focused on accelerated healing and single curative treatments for large bone defects, bone non-union, and spine fusion. The 3M³ technology platform consists of a 3-dimensional, scaffold-free, extracellular matrix (ECM) utilizing differentiated adipose-derived stem cells (ASCs), to generate highly specific growth factors and miRNAs to restore the physiology of natural healing. The technology is based on adipose-derived stem cells, which are easily harvested from the patient’s or donor’s fatty tissue and when differentiated, have superior osteogenic properties compared to bone marrow-derived stem cells. The platform generates a continuous cycle where active particles are combined with the differentiated ASCs to produce an extracellular matrix containing a cocktail of bioactive ASCs, highly specific miRNA, growth factors, and proteins, all of which work together to promote accelerated stable tissue regeneration.

How do you plan on leveraging the €40 million raised in November 2022?

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 cell-derived product that can provide accelerated, durable bone union in spinal fusion procedures and non-healing fractures, and NVD-003, an autologous cell-based product designed to provide a single treatment cure for patients with critical size bone defects such as congenital pseudarthrosis of the tibia (CPT).

What is your commercial strategy to grow with the US market, and what do you ambition to achieve through the planned IPO in 2024?

Our commercial strategy is centered around three key objectives: seeking partnerships, capitalizing on market opportunities, and our preclinical development efforts. We plan on continuing our efforts to identify reliable domestic or international partners, along with maintaining investor relationships. As a small company, we currently have a US investor –– New Science Venture –– as the lead investor of our Series A funding round. We also have Belgian funds, but we see our market as being largely in the US. It is also important that Novadip is fully supported by our Board and current investors concerning positioning the company for the next funding round.

What will be the main trends in tissue and bone regenerative medicines in the near term?

There are currently no treatments specifically approved for CPT. The current standard of care for CPT is surgery with a bone autograft, which is associated with poor long-term outcomes. There is an urgent need for design concepts and formulation methods to create new bone regeneration and repair scaffolds. With the increased emphasis on scaffold materials and nanotechnology in the field of bone tissue engineering, there are more possibilities for scaffold chemical modification— allowing for more control options.

How do you view the current funding climate for biotechs?

Clearly, this is a challenging time for the biopharma industry as a whole. Fortunately, we have several things going for us. We have a technology platform that is capable of generating multiple products that address large market opportunities, we have established proof of clinical concept for two therapeutic assets and will be generating data from human studies within the next 12 months, and we have a cash runway through the end of 2024 that will support clinical development of these assets.

What are the milestones ahead for Novadip and how do you forecast 2023 to shape up for you?

I believe 2023 and 2024 will be key for Novadip. We have already closed two trials in the autologous program. We are now in Phase 1/2 trials for CPT in young patients, both in the US and in Europe. We are enrolling four or more young patients that require complete regeneration of part of their tibias in a trial for adipose tissue treatment for humans, and we expect the first four patients to start therapy in 2023. By mid-2024, Novadip will have added more staff to support two additional trials for the off-the-shelf product NVD-X3, which will each enroll 10 patients with bone non-union from trauma and spinal injury.