BURLINGTON, Mass. / Sep 26, 2023 / Business Wire / Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiologic products for spine fusion markets, provides an update on its clinical development initiatives with its NB1 bone graft device.

NB1 consists of the recombinant human protein NELL-1 combined with demineralized bone matrix (DBM). The 30-patient pilot study is expected to be conducted in Australia. Earlier this year, the Human Research Ethics Committee approved Monash Health as the first site.

“We are encouraged by the ongoing progress in preparing to advance NB1 into human testing and look forward to the start of our pilot study before the end of the year,” said Jeffrey Frelick, president and chief executive officer of Bone Biologics.

The company has completed the following preparatory activities:

Assay Qualification and Validation

All analytical assays required for the drug substance and the drug product have been successfully validated. Similar recombinant human NELL-1 (rhNELL-1) drug substance attributes were demonstrated between different rhNELL-1 lots and the cGMP drug substance lot.

The in vitro cell-based attachment potency assay has been successfully qualified. Similar relative potency was demonstrated between different rhNELL-1 lots and the cGMP drug substance lot has passed the potency specification. In vivo potency testing demonstrated osteopromotion activity for the cGMP rhNELL-1 drug substance.

The engineering and the cGMP drug substance lots have passed all required specifications.

Medical Device Biocompatibility Testing

The ISO 10993 GLP biocompatibility testing has been completed. NB1 showed no evidence of causing cell lysis or toxicity, no sensitization and was not mutagenic or pyrogenic. The clinical observations, body weights, necropsy observations, organ weights, organ/body weight ratios and organ/brain weight ratios were not adversely affected by implantation of NB1 or control articles. There were no changes in hematology or clinical chemistry values considered related to NB1 implantation. Microscopic evaluation of collected organs revealed no evidence of a systemic test article related response.

Master Cell Bank Safety

The master cell bank biosafety testing was successfully completed.

Stability

rhNELL-1 drug product stability was demonstrated for purity, potency visual appearance, color, clarity, pH and protein concentration up to six months.

The planned pilot clinical trial is a multicenter, parallel group, randomized trial designed to evaluate the safety and preliminary effectiveness of NB1 bone graft in 30 subjects with degenerative disc disease undergoing a TLIF procedure.

Mr. Frelick added, “We believe NB1 is poised to address the problems with existing bone growth products by providing rapid, controlled and guided bone growth only in the presence of existing bone. Our longer-term goal is to capture a meaningful portion of the $3 billion annual global market for spine fusion products. Lumbar degenerative disc disease is a common cause of lower back pain, which may lead to disability. We are excited to be embarking on a potential opportunity to improve quality of life for millions of patients.”

About NELL-1

NELL-1 is a recombinant human protein licensed through a technology transfer agreement with the UCLA Technology Development Group for worldwide applications. NELL-1 combined with DBM forms the product candidate, NB1.

The inclusion of rhNELL-1 in the NB1 bone graft device provides an ancillary osteopromotive effect that is expected to increase both the quantity and maturity of bone and to increase the rate of spinal fusion. The proposed mechanism of action for rhNELL-1 to improve bone formation involves classic receptor binding and intracellular signaling transduction to the nucleus to promote osteogenic gene expression and bone formation.

NELL-1 has unique properties that suggest it will be ideal in 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, specific and guided control over bone regeneration. The company is optimistic that NB1 may provide an important alternative to a vexing clinical problem by improving the safety profile of an osteopromotive orthobiologic.

There is a large and established opportunity for NB1 with an estimated global market of $3 billion annually just for bone graft substitutes in spine fusion for products such as growth factors, DBM, synthetic materials, stem cells and allografts. This is the market Bone Biologics intends to address. Longer term, additional market opportunities await NB1 including the $11 billion annual market for treating osteoporosis and the $8 billion annual market for treating trauma patients.

About Bone Biologics

Bone Biologics is undertaking groundbreaking work with select strategic partners that builds on the preclinical research of the NELL-1 protein. Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion procedures, while additionally having rights to trauma and osteoporosis applications. For more information, please visit www.bonebiologics.com.

Forward-looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes,'' "expected” “will,” “before,” “planned,” “goal,” “may,” “intends,” and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties including the ability for the Company to advance NB1 into human testing; the timing of the Company’s pilot clinical study; related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; the preclinical and clinical results for NB1, which may not support further development; the Company’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; and the Company’s ability to capture any portion of the $3 billion annual global market for spine fusion products. 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 including the Company's ability to develop our lead product NELL-1 and other proposed products, its ability to obtain patent protection for its technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended December 31, 2022 and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.