Bone Biologics Corporation (NASDAQ: BBLG), a
developer of orthobiologic products for spine fusion markets, today
issued the following letter to stockholders from its President and
Chief Executive Officer, Jeffrey Frelick.
To My Fellow Stockholders:
I am delighted to update you on Bone Biologics’ development work
with NELL-1 over the past year and to review our expected
milestones over the coming months in anticipation of commencing our
first-in-human pivotal study in 2023. As a reminder, NELL-1 is a
recombinant human protein that we licensed through a technology
transfer agreement with the UCLA Technology Development Group (UCLA
TDG) for worldwide applications. NELL-1 combined with demineralized
bone matrix (DBM) forms our product candidate, NB1.
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. We are 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.
A great deal of development work has been undertaken with NELL-1
in preparation for our first pilot clinical trial in Australia.
Publications support NELL-1’s mechanism of action and its potential
for better bone formation, as preclinical animal data have been
both extensive and compelling. Of particular importance is a study
that evaluated the efficacy of NB1 as a novel bone graft material
for interbody spine fusion in sheep, a phylogenetically advanced
animal with spine fusion similarities to humans. That study found
that NB1 safely and effectively promoted spine fusion.
With compelling preclinical data, we have moved forward with
important activities to prepare for our human pilot study. Thus far
in 2022, we entered into an agreement with MTF Biologics for
supplying DBM as a carrier in our combination product. MTF
Biologics, a highly regarded industry innovator, is a global
nonprofit 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 engaged a contract development
manufacturing organization (CDMO) that offers a global site network
from process development to recombinant protein manufacturing.
Because NELL-1 is a recombinant human protein that will be utilized
in humans, it must be manufactured in specialized facilities,
therefore engaging a CDMO was an important preparatory step.
Updated Agreement with UCLA
In 2006 we entered into an agreement with UCLA Technology
Development Group to license NELL-1. This agreement is the
foundation for Bone Biologics.
We most recently modified that agreement in May 2022 to enable
us to preserve available capital and resources to develop our
product. Under the modification, UCLA TDG will defer payment of the
diligence fee until we (or any of our sublicensees) sell any
product in accordance with the revised payment schedule.
Recent Equity Financing
We recently raised gross proceeds of $5.1 million in an
underwritten public offering of units of common stock and warrants.
We expect to use the net proceeds to fund our planned clinical
trials, maintain and extend 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 30-patient pilot study with NB1 next year.
Expectations through 2023
As we look to the remainder of 2022, we are working toward
several value-creating events:
- In preparation for the cGMP manufacturing run for product that
will be used in our human clinical study, assays will be developed
that characterize NELL-1 (including the potency assay, which
quantitates the bone formation activity), a Master Cell Bank will
be developed and scaling activities will be performed.
- We are building a quality system to meet the conditions of
Essential Principles required by the Australian regulatory
authorities prior to the initiation of human studies.
- We will also engage another CDMO that will perform fill/finish
functions. This activity is required to ensure sterility, which is
another requirement prior to human implantation.
Looking to 2023, we plan to commence a 30-patient clinical trial
in Australia. This will be a multicenter, prospective, randomized
pilot study evaluating the safety and preliminary effectiveness of
NB1 in subjects with degenerative disc disease undergoing
transforaminal lumbar interbody fusion.
As currently envisioned, the study will evaluate two
concentrations of NB1 relative to the autograft control. The
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 to measure a patient’s
permanent functional disability.
The Need for NELL-1 in a Compelling Market
The scientific basis for developing NB1 is the potential for
increased safety and for better fusion rates. Spine fusion is a
commonly performed surgical procedure in the treatment of numerous
spinal diagnoses including degenerative disc disease, spinal
stenosis, spondylolisthesis and other spinal deformities. A bony
fusion is essential for restoring segmental stability, preventing
or correcting deformity and improving long-term outcomes. Lumbar
intervertebral fusion is achieved by creating an environment that’s
conducive to the formation of a continuous osseous 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 advance
NB1 along the development pathway. We believe our effort will be
well-rewarded not only by patients, but also by caregivers and Bone
Biologics stockholders. I extend thanks to all of our constituents
for their ongoing support.
Sincerely,
Jeffrey Frelick Chief Executive Officer
October 25, 2022
About Bone Biologics
Bone Biologics was founded to pursue regenerative medicine for
bone. The Company 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,''
"anticipates," "expects" 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.
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, 2021
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221025005011/en/
LHA Investor Relations Kim Sutton Golodetz 212-838-3777
kgolodetz@lhai.com
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