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Bone Biologics Corporation (NASDAQ: bblg)a developer of orthobiological products for the spinal fusion markets, today sent the following letter to shareholders from its Chairman and CEO, Jeffrey Frelick.
To my fellow shareholders:
I am pleased to report on Bone Biologics’ development work with NELL-1 over the past year and review our expected milestones in the coming months before we begin our first pivotal human study in 2023. As a reminder, NELL-1 is a human protein. recombinant that we license through a technology transfer agreement with the UCLA Technology Development Group (UCLA TDG) for applications worldwide. NELL-1 combined with demineralized bone matrix (DBM) forms our candidate product, NB1.
NELL-1 has unique properties that suggest it will be ideal for treating spinal fusion, trauma, osteoporosis, and other bone-related indications, and may be especially useful among “hard healers.” This potential lies in its ability to provide rapid, targeted and guided control over bone regeneration. We are optimistic that NB1 may provide an important alternative to a vexing clinical problem by improving the safety profile of an osteopromoting orthobiologic.
There is a large and established opportunity for NB1 with an estimated $3 billion annual global market for bone graft substitutes in spinal fusion alone for products such as growth factors, DBM, synthetic materials, stem cells and allografts. This is the market that Bone Biologics intends to address. Longer term, additional market opportunities await NB1, including the $11 billion annual market for the treatment of osteoporosis and the $8 billion annual market for the treatment of trauma patients.
A great deal of development work has been carried out on NELL-1 in preparation for our first pilot clinical trial in Australia. Publications support the mechanism of action of NELL-1 and its potential for enhanced bone formation, as preclinical data in animals has been extensive and convincing. Of particular importance is a study that evaluated the efficacy of NB1 as a new bone graft material for interbody spinal fusion in sheep, a phylogenetically advanced animal with spinal fusion similarities to humans. That study found that NB1 safely and effectively promoted spinal fusion.
With compelling preclinical data, we have moved forward with important activities to prepare for our human pilot study. So far in 2022, we have signed an agreement with MTF Biologics to supply DBM as a carrier in our blended product. MTF Biologics, a highly regarded industry innovator, is a global not-for-profit organization that provides one of the orthopedic industry’s largest portfolios of allograft tissue. MTF Biologics’ DBM will comprise half of our NB1 product.
Earlier this year, we also contracted with a contract development manufacturing organization (CDMO) that offers a global network of sites from process development to recombinant protein manufacturing. Because NELL-1 is a recombinant human protein that will be used in humans, it must be manufactured in specialized facilities, so involving a CDMO was an important preparatory step.
Updated agreement with UCLA
In 2006 we signed an agreement with the UCLA Technology Development Group to license NELL-1. This agreement is the foundation of Bone Biologics.
We recently modified that agreement in May 2022 to allow us to preserve the capital and resources available to develop our product. Under the amendment, UCLA TDG will defer payment of the due diligence fee until we (or any of our sublicensees) sell any product in accordance with the revised payment schedule.
Recent Capital Financing
We recently raised gross proceeds of $5.1 million in an underwritten public offering of common stock units and warrants. We expect to use the net proceeds to fund our planned clinical trials, maintain and expand our patent portfolio, retain contract research organizations and for working capital and other general corporate purposes. Importantly, these funds will allow us to begin our pilot study of 30 NB1 patients next year.
Expectations until 2023
As we look ahead to the rest of 2022, we are working on several value creation events:
- In preparation for cGMP production for the product to be used in our human clinical study, assays characterizing NELL-1 will be developed (including the potency assay, which quantifies bone-forming activity), a Master Cell Bank will be developed and Scaling activities will be carried out.
- We are building a quality system to meet the Essential Principles conditions required by Australian regulatory authorities before the start of human studies.
- We will also contract with another CDMO that will perform fill/completion functions. This activity is necessary to ensure sterility, which is another prerequisite for human implantation.
Looking ahead to 2023, we plan to start a 30-patient clinical trial in Australia. This will be a multicenter, prospective, randomized pilot study evaluating the safety and preliminary efficacy of NB1 in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion.
As currently planned, the study will evaluate two concentrations of NB1 relative to autograft control. Primary endpoints will include fusion success at 12 and 24 months after surgery, and change from the baseline Oswestry Disability Index, which is the Gold Standard tool for measuring permanent functional disability of a patient. patient.
The need for NELL-1 in an attractive market
The scientific basis for developing NB1 is the potential for better safety and better fusion rates. Spinal fusion is a surgical procedure that is commonly performed in the treatment of numerous spinal diagnoses, including degenerative disc disease, spinal stenosis, spondylolisthesis, and other spinal deformities. A bony fusion is essential to restore segmental stability, prevent or correct deformity, and improve long-term results. Lumbar intervertebral fusion is achieved by creating an environment conducive to the formation of a continuous bony bridge across the involved spinal segments.
We are optimistic that spinal fusion patients will benefit from our solution to the problem of hard-to-heal bones, and we are very excited about the potential to help these patients as we move forward with the development of NB1. We believe that our effort will be well rewarded not only by patients, but also by caregivers and Bone Biologics shareholders. I extend my thanks to all of our constituents for their continued support.
To be honest,
October 25, 2022
About Bone Biologics
Bone Biologics was founded to focus on regenerative bone medicine. The Company is conducting innovative work with select strategic partners that builds on preclinical research on the Nell-1 protein. Currently, Bone Biologics is focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion procedures, while also having rights for trauma and osteoporosis applications. For more information please visit www.bonebiologics.com.
Certain statements contained in this press release, including, without limitation, statements containing the words “believes”, “anticipates”, “expects” and words of similar meaning, constitute “forward-looking statements” within the meaning of the Securities Policy. Private. Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those that include the Company’s ability to develop our main product NELL-1 and other proposed products, its ability to obtain patent protection for its technology, its ability to obtain the necessary funding to develop products and conduct the necessary clinical trials, its ability to obtain approval from the Federal Food and Drug Administration to market any products it may develop in the United States, and to obtain any other regulatory approval necessary to market any product in other countries, your ability to market any product you may develop, your ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the business strategy or development plans of the Company; competition; business interruptions; adverse publicity and general international, national and local economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and results of operations” on the Company’s Form S-1, Form 10-K for the year ended December 31, 2021 and other Company filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statement to reflect any event or circumstance that may arise after the date hereof.
LHA Investor Relations
Kim Sutton Golodetz
Source: Bone Biologics Corporation