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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): June 20, 2024
BONE
BIOLOGICS CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-40899 |
|
42-1743430 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
2
Burlington Woods Drive, Ste. 100
Burlington,
MA |
|
01803 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (781) 552-4452
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
BBLG |
|
Nasdaq
Capital Market |
|
|
|
|
|
Warrants
to Purchase Common Stock, par value $0.001 per share |
|
BBLGW |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 | Regulation
FD Disclosure. |
On
June 20, 2024, Bone Biologics Corporation (the “Company”) issued a press release announcing that the first two patients have
been treated in its pilot clinical study of the Company’s NB1 bone graft device in spine fusion. A copy of the press release is
attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The
information furnished pursuant to this Item 7.01, including Exhibit 99.1 shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under
such section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933,
as amended, or the Exchange Act.
Item
9.01 | Financial
Statements and Exhibits. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
|
BONE
BIOLOGICS CORPORATION |
|
|
|
Date:
June 20, 2024 |
|
|
|
By: |
/s/
Jeffrey Frelick |
|
|
Jeffrey
Frelick |
|
|
Chief
Executive Officer |
Exhibit
99.1
First
Two Patients Treated in Pilot Clinical Study with Bone Biologics’ NB1 Bone Graft Device in Spine Fusion
Reminder:
Management “CEO Chat” with Zacks Small-Cap Research Analyst Begins Today at 11 a.m. Eastern Time
BURLINGTON,
Mass. (June 20, 2024) — Bone Biologics Corporation (“Bone Biologics” or the “Company”)
(Nasdaq: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, announces that the first two patients
have been treated in the multicenter, prospective, randomized pilot clinical study of the Company’s NB1 bone graft device. NB1
is NELL-1 protein combined with demineralized bone matrix (DBM) to provide rapid, specific and guided control over bone regeneration.
This
pilot clinical study 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. 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 patients were treated in Australia. 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.
“We
have worked diligently to prepare for this important milestone and are delighted that the first patients have been treated in our pilot
clinical study,” said Jeffrey Frelick, president and chief executive officer of Bone Biologics. “Preclinical animal studies
demonstrated a strong safety profile, fusion success and bone healing of NB1, and we are optimistic that we will show fusion success
in humans.
“There
is clear need for a product that creates rapid, controlled and guided bone growth only in the presence of existing bone and not elsewhere
in the body. We aim to demonstrate that NB1 will address this opportunity and compete in the $3 billion annual global market for spine
fusion products,” he added.
Lumbar
DDD is one of the most common causes of low back pain. DDD also leads to substantial disability, with many patients suffering from decreased
ability to walk, sit, stand and/or sleep. For some people, DDD is part of the natural process of growing older and is a significant medical
issue that is increasing as the global population ages.
“CEO
Chat” Reminder
Bone
Biologics reminds investors that Jeffrey Frelick, the Company’s president and chief executive officer, and Deina Walsh, chief financial
officer, will be interviewed by Zacks Small-Cap Research analyst Brad Sorensen, CFA in a “CEO Chat” today at the Life Science
Investor Forum with Virtual Investor Conference hosted by VirtualInvestorConferences.com.
The
interview will begin at 11:00 a.m. Eastern time and can be viewed here. Investors are encouraged to preregister to expedite participation
and receive event updates, and are invited to ask questions during the event via a chat function.
About
NB1
The
Company’s product candidate NB1 combines the recombinant human NELL-1 (rhNELL-1) protein with demineralized bone matrix. 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 so-called “hard healers.” This potential lies in its ability to provide rapid, specific
and guided control over bone regeneration.
For
the NB1 bone graft device, the inclusion of rhNELL-1 provides an ancillary osteopromotive effect that is expected to increase the incidence.
The proposed mechanism of action for rhNELL-1 to improve bone formation is based on published research and involves classic receptor
binding and intracellular signaling transduction to the nucleus to promote osteogenic gene expression and bone formation.
There
is a large and established opportunity for NB1 with an estimated global market of $3 billion annually for bone graft substitutes in spine
fusion for products such as growth factors, DBM, synthetic materials, stem cells and allografts. Additional longer-term market opportunities
include the $11 billion annual market for treating osteoporosis and the $8 billion annual market for treating trauma.
About
Bone Biologics
Bone
Biologics was founded to pursue regenerative medicine for bone. The Company is undertaking work with select strategic partners that builds
on the preclinical research of the NELL-1 protein. Bone Biologics is focusing 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 regarding the timing, implementation, and success
of the company’s pilot clinical study, the ability of the company’s lead product candidate NB1 to provide rapid, specific
and guided control over bone regeneration and show fusion success in humans, the ability of NB1 to compete in global markets, as well
as statements containing the words “will,” “expect,” 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, but not limited to, market and other 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 Annual Report on Form 10-K for
the year ended December 31, 2023 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.
Contact:
LHA
Investor Relations
Kim
Sutton Golodetz
212-838-3777
kgolodetz@lhai.com
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