By Brad Sorensen, CFA
NASDAQ:BBLG
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Bone Biologics (NASDAQ:BBLG) is a company developing products for spine fusion market and is entering an exciting and crucial time period as human trials have begun and results should be available, at least preliminary data, in the coming year. Given the preclinical studies that we’ve reported on extensively, we are optimistic that exciting results will be forthcoming that will positively impact the lives of thousands of spinal injury patients.
The company recently released its 2Q2025 financial results that showed a loss of $1.33 per share, in line with estimates but saw cash grow to $6.3 million. For a clinical stage company, having cash on hand is vital and the company notes that it has enough cash to finance operations into the second quarter of 2026, which gives us comfort as we await test results from the trial discussed below.
Late last year, the company announced an important milestone—the first two human patients have been treated in the company’s NB1 bone graft device. This marks the start of the pilot clinical study that will evaluate NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative disc disease (DDD) and will evaluate safety and effectiveness, fusion success, pain, function improvement and adverse events. According to the company, in order to be enrolled in the study, patients must have DDD at one level from L2-S1 and may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level. These two initial patients were treated in Australia. As we’ve noted before, the study design was previously reviewed and agreed upon by the U.S. Food and Drug Administration’s Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States.
There are approximately 350,000 spinal fusion surgeries done in the US every year with varying degrees of success in alleviating often debilitating back pain. The existing dominant technology, known as rhBMP, has been quite successful in advancing the spinal fusion procedure but there are also challenges that can come along with using that technology. Patients can experience such impacts as rapid, uncontrolled bone growth that causes an unsound structure and unwanted bone formation where bone will grow where it is not intended. Back pain impacts 65 million Americans, with 16 million of those having what would be considered chronic back pain, leading to an estimated $12 billion per year in health care and indirect cost according to the Georgetown Policy Institute. While spinal fusion surgery isn’t the appropriate treatment for every kind of back pain, it can help to relieve the pain associated with a variety of conditions.
The NELL-1 technology at the heart of NB1 is the centerpiece of what Bone Biologics is developing. It was developed by UCLA TDG and Bone holds the exclusive worldwide rights to that technology. NELL-1 has been reviewed positively in over 45 peer reviewed publications demonstrating technological viability. NELL-1 has shown spine fusion effectiveness across three animal species—rodent, sheep and nonhuman primate and has competed two clinically relevant sheep studies that demonstrated NELL-1 increases the fusion rate and quantity of bone compared to the control group.
Summary
We have written before about the market opportunity that BBLG has, and it continues to grow. If trial results are positive, as we believe they will be, the positive reaction in the investing community will likely be swift. We continue to be excited about the opportunity and the science behind NELL-1 and are looking forward to the results from the human trials ongoing this year. BBLG has what we believe is a product with great potential, addressing a market with seemingly insatiable demand and a solid funding situation, which is vital in this environment. As such, we believe investors with a longer-term investing horizon should take a look at BBLG.
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