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): February 5, 2024
BioRestorative Therapies, Inc.
(Exact name of registrant as specified in its charter)
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Nevada
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001-37603
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30-1341024
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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40 Marcus Drive
Melville, New York
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11747
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(Address of principal executive offices)
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(Zip code)
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Registrant's telephone number, including area code (631) 760-8100
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, $0.0001 par value
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BRTX
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NASDAQ Capital Market
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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 (see General Instruction A.2. below):
☐ 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))
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. ☐
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Item 7.01
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Regulation FD Disclosure.
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On February 5, 2024, BioRestorative Therapies, Inc. (the “Company”) issued a press release (the “Press
Release”) announcing the public availability of a poster (the “Poster”) titled “Autologous Stem Cell Therapy for Chronic Lumbar Disc Disease, Initial Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured
Mesenchymal Stem Cells”. The Poster, which was presented on February 4, 2024 by the Company’s Vice President of Research and Development, Francisco Silva, at the Orthopaedic Research Society (ORS) 2024 Annual Meeting (the “ORS Annual Meeting”),
describes preliminary 26–52 week blinded data from the ongoing Phase 2 clinical trial of the Company’s lead clinical candidate, BRTX-100, in subjects with chronic lumbar disc disease. In the Press Release, the Company also announced again that it
will hold a webcasted conference call with an associated slide presentation on February 5, 2024 at 8:30 a.m. ET to review the Poster. A copy of the Press Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The Company intends to use the Poster from time to time on and after February 4, 2024 in presentations
about the Company’s business. As indicated above, the Company used the Poster at the ORS Annual Meeting on February 4, 2024 and may use the Poster, possibly with modification, in other presentations to current and potential investors, lenders,
creditors, insurers, vendors, customers, employees and others with an interest in the Company and its business.
The information contained in the Poster is summary information that should be considered in the context
of the Company’s filings with the Securities and Exchange Commission and other public announcements that the Company may make by press release or otherwise from time to time. The Poster speaks as of the date of this Current Report on Form 8-K.
While the Company may elect to update the Poster in the future or reflect events and circumstances occurring or existing after the date of this Current Report on Form 8-K, the Company specifically disclaims any obligation to do so. The Poster is
furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Poster will also be posted in the Investor Relations section of the Company’s website, www.biorestorative.com, for 90 days.
The information referenced under this Item 7.01 (including Exhibits 99.1 and 99.2 referenced in Item 9.01
below) of this Current Report on Form 8-K is being “furnished” under “Item 7.01. Regulation FD Disclosure” and, as such, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liabilities of that section. The information set forth in this Current Report on Form 8-K (including Exhibits 99.1 and 99.2 referenced in Item 9.01 below) shall not be incorporated by reference into any registration
statement, report or other document filed by the Company pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits.
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Number
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Description
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99.1
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Press release, dated February 5, 2024, issued by BioRestorative Therapies, Inc.
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99.2
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Poster
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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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.
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BIORESTORATIVE THERAPIES, INC.
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Dated: February 5, 2024
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By:
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/s/ Lance Alstodt
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Lance Alstodt
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President and CEO
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BioRestorative Therapies Presents Preliminary Clinical Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc
Disease
— Preliminary data includes 26 and 52-week follow-up end points as part of ongoing Phase 2
trial —
— Company to host webcasted conference call today at 8:30am EST —
MELVILLE, N.Y., February 5, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced the public availability of a poster, presented yesterday at the
Orthopaedic Research Society (ORS) 2024 Annual Meeting, which describes preliminary 26 and 52 week blinded data from the ongoing Phase 2 clinical trial of the Company’s lead clinical candidate, BRTX-100, in subjects with chronic lumbar disc disease
(“cLDD”).
The presented poster, titled “Autologous Stem Cell Therapy for Chronic Lumbar Disc Disease; Initial Phase 2 Clinical Safety and
Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells” can be accessed on the Company’s website at www.biorestorative.com under “Scientific Publications” in the Product Candidate section. During a webcasted conference
call scheduled for 8:30am EST today, BioRestorative management will be available to discuss data from the presentation as well as provide a clinical update.
Previous clinical studies have demonstrated that the harsh microenvironment of the disc could impact cell dose viability and result in
a non-efficacious or the worsening of clinical outcomes. Although this is blinded and early clinical data, it is important to note that the Visual Analog Scale, Oswestry Disability Index, Roland Morris Disability Questionnaire, and Functional Rating
Index collected at weeks 26 and 52 post-injection demonstrated a positive trend compared to baseline. In addition to safety outcomes, changes to these pain and function scales compared to baseline are used by the U.S. Food and Drug Administration
(FDA) to determine whether the trial will be allowed to proceed and ultimately gain Biologics License Application (BLA) approval.
“We are thrilled with the progress of our ongoing clinical development programs. With regard to the Phase 2 study investigating the
use of BRTX-100 in the treatment of cLDD, we are strongly encouraged by the preliminary data presented at ORS 2024. The preliminary clinical data shows meaningful signals in patients enrolled in the study and, importantly, no notable safety signals,”
said Lance Alstodt, Chief Executive Officer of BioRestorative.
Conference Call & Webcast Information
BioRestorative management will host a webcasted
conference call with an associated slide presentation today, February 5, at 8:30AM EST. To join the conference call via phone and participate in the live Q&A session, please dial 888-506-0062 (United States) or 973-528-0011 (International), participant access code 234972. The live webcast and audio archive of the
presentation may be accessed on the investor section of the BioRestorative website at https://www.biorestorative.com/investor-relations/. An archived replay will be available for approximately 90 days following the event.
About BRTX-100
BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is the Company’s lead
clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites
in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or control.
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols,
primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:
• Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the
non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production
process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who
potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from
degenerative disc disease.
• Metabolic Program (ThermoStem®): We are developing a cell-based therapy candidate to target obesity and metabolic
disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates
that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and
diabetes.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned
that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other
risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place
undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
CONTACT:
Email: ir@biorestorative.com