バイオリストラティブセラピーズの適時開示・決算・その他

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): November 12, 2024

BioRestorative Therapies, Inc.

(Exact name of registrant as specified in its charter)

Nevada		001-37603		30-1341024
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

40 Marcus Drive Melville, New York		11747
(Address of principal executive offices)		(Zip code)

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:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value	BRTX	NASDAQ Capital Market

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. ☐

Item 2.02.

Result of Operations and Financial Condition.

On November 12, 2024, BioRestorative Therapies, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2024 (the “Financial Press Release”). The Financial Press Release also provided a business update and included details with regard to the conference call to be held to discuss the third quarter results and business update. A copy of the Financial Press Release is furnished as Exhibit 99.1 hereto.

The information contained in the Financial Press Release 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 information furnished with this Item 2.02, 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 of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 7.01

Regulation FD Disclosure.

See Item 2.02 above.

On November 13, 2024, the Company issued a press release (the “Presentation Press Release”) announcing that additional preliminary 26 and 52 week blinded data from the ongoing Phase 2 clinical trial of BRTX-100 in subjects with chronic lumbar disc disease would be presented by Francisco Silva, the Company’s Vice President of Research and Development, at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium, taking place November 10-14, 2024 in Skytop, Pennsylvania. The presentation took place on November 13, 2024. In the Presentation Press Release, the Company also announced that at the conference call to be held to discuss the Company’s third quarter results and business update, the Company will also review the BRTX-100 presentation. A copy of the Presentation Press Release is furnished as Exhibit 99.2 hereto. At the symposium certain presentation materials (the “Presentation Materials”) may be utilized by Mr. Silva. A copy of the Presentation Materials is furnished as Exhibit 99.3 hereto. The Company may use the Presentation Materials, 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 Presentation Press Release and the Presentation Materials 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 information in the Financial Press Release, the Presentation Press Release and the Presentation Materials is being furnished, not filed, pursuant to this Item 7.01. Accordingly, the information in the Financial Press Release, the Presentation Press Release and the Presentation Materials will not be incorporated by reference into any registration statement filed by the Company under the Securities Act unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Current Report on Form 8-K with respect to the Financial Press Release, the Presentation Press Release and the Presentation Materials is not intended to, and does not, constitute a determination or admission by the Company that the information in this Current Report on Form 8-K with respect to the Financial Press Release, the Presentation Press Release and the Presentation Materials is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Number	Description

99.1	Press release, dated November 12, 2024, issued by BioRestorative Therapies, Inc.

99.2	Press release, dated November 13, 2024, issued by BioRestorative Therapies, Inc.

99.3	Presentation Materials

104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

	Company Name

Dated: November 13, 2024	By:	/s/ Robert Kristal
		Robert Kristal
		Chief Financial Officer

EX-99.1 5 ex99_1.htm PRESS RELEASE DATED NOVEMBER 12, 2024

Ex 99.1

BioRestorative Therapies Reports Third Quarter 2024 Financial Results and Provides Business Update

MELVILLE, N.Y., November 12, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today reported financial results for the third quarter ended September 30, 2024 and provided an update on its business.

“We have continued to execute well across all areas of our business and are looking forward to continuing to update investors on our progress as we close out the remainder of 2024,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “From an operating perspective, we are thrilled with our third quarter results, as we are seeing initial progress on our path to sustainable profitability, driven by cost containment activities coupled with increased resources dedicated to our commercial programs.”

Recent Highlights

DEVELOPMENT

•

Last week, BioRestorative announced that it received a provisional license from the New York State Department of Health (“NYSDOH”) for the processing of allogeneic (non-autologous) donor tissue material for the isolation, expansion and cryopreservation of various cell types, including stem cells, for medical research. Previously, the Company was licensed by the NYSDOH to act as a tissue bank for the processing of mesenchymal stem cells derived from autologous donors only.

Disc/Spine Program

•

In a podium presentation scheduled for tomorrow morning, new preliminary 26–52 week blinded data from the ongoing Phase 2 clinical trial of BRTX-100 in subjects with chronic lumbar disc disease will be presented by Francisco Silva, Vice President of Research and Development, at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium. BioRestorative will also make the data available through a public announcement.

•	BioRestorative continues to work toward achieving completion of patient enrollment in the Phase 2 BRTX-100 study before the end of 2024.

Metabolic Program

•

In September, the Company shared the details of its allogeneic, off-the-shelf ThermoStem® metabolic disease platform at IFATS 2024. BioRestorative believes that cell-based therapy candidates generated from its ThermoStem® program may allow for lower dosing, and while current GLP-1 based obesity drugs result in a loss of 20-40% lean muscle mass of total weight loss, pre-clinical studies have demonstrated that brown fat activation leads to positive effects on several organs, including heart, liver and muscle.

•

In October, BioRestorative announced that the Israel Patent Office had issued a Notice of Allowance for a new patent application (Israeli Patent Appl. No. 287557) covering several fundamental aspects of the ThermoStem® platform. This, the 14th international patent to issue outside of the U.S. for the technology, covers non-naturally occurring three-dimensional brown adipose derived stem cell (BADSC) aggregates; an encapsulation system comprising the non-naturally occurring three-dimensional brown adipose derived stem cell aggregates; a method of making a non-naturally occurring three-dimensional brown adipose derived stem cell aggregate; and a method of treating a patient with a disorder.

•

The Company’s previously reported substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license of BioRestorative’s ThermoStem® metabolic intellectual property are continuing; however, no assurances can be given that a license agreement will be entered into whether on commercially reasonable terms or otherwise.

COMMERCIAL

BioCosmeceuticals

•	BioRestorative derived $230,700 in product revenue from its exclusive supply agreement with Cartessa Aesthetics, LLC in the third quarter.

Summary Third Quarter 2024 Results

For the quarter ended September 30, 2024, the Company had a loss from operations of $2.3 million, a 26% year-over-year improvement from $3.1 million for the comparable period of 2023, and a 9% improvement sequentially from $2.5 million in the second quarter of 2024.

The Company’s net loss for the 2024 third quarter was $1.1 million, or $0.13 per share.

The Company ended the third quarter in a very strong financial position, with cash, cash equivalents, and investments held in marketable securities of $13.1 million, with no outstanding debt, as of September 30, 2024.

For complete financial results, please see BioRestorative’s filings at www.sec.gov, and on the Company's website at www.biorestorative.com under "SEC Filing" in the Investors and Media section.

November 13, 2024 Conference Call Details

BioRestorative management will host a webcasted conference call with an associated slide presentation at 4:30pm EST on Wednesday, November 13, 2024 to review its third quarter 2024 financial results and provide a business update, as well as to review the BRTX-100 presentation. To join the conference call via phone and participate in the live Q&A session tomorrow, please dial 877-545-0320 (United States) or 973-528-0002 (International), participant access code 823128. The live webcast (with slides) 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 BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products:

• 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 cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. 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. BADSC secreted exosomes may also impact weight loss.

• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA) approvals in the emerging BioCosmeceuticals space.

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, as amended, 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:

Stephen Kilmer

Investor Relations

Direct: (646) 274-3580

Email: skilmer@biorestorative.com

EX-99.2 6 ex99_2.htm PRESS RELEASE DATED NOVEMBER 13, 2024

Ex 99.2

BioRestorative Therapies Reports Positive Preliminary Phase 2 BRTX-100 Clinical Data

– Blinded preliminary data demonstrate a positive trend and clear signal in Primary and Secondary endpoints –

– Patient reported efficacy outcomes show a material decrease in pain and increase in function –

– If positive trends continue, Company confident that the Phase 2 trial will meet its Primary and Secondary end points -

– The blinded preliminary BRTX-100 data to be described in a podium presentation this morning at the ORS PSRS 7th International Spine Research Symposium –

– Webcasted conference call also scheduled for today at 4:30pm EST –

MELVILLE, N.Y., November 13, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, today announced new preliminary 26–52 week blinded data from the first 10 patients with chronic lumbar disc disease (“cLDD”) enrolled in the ongoing Phase 2 clinical trial of 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 placebo.

No serious adverse events (SAEs) were reported in any of the 10 safety run-in subjects. Notably, there was also no dose (40X106 cells) limiting toxicity at 26-52 weeks.

In addition to the aforementioned preliminary primary safety endpoint data, the Company reported blinded clinical data on the secondary efficacy endpoint of at least a 30% decrease in pain as measured on the Visual Analog Scale (“VAS”) and at least a 30% increase in function based on the Oswestry Disability Index (“ODI”) at week 52. The blinded preliminary efficacy endpoint data demonstrated:

•	At 26 weeks, 70% of subjects (n=10) reported a >30% improvement in VAS versus baseline;

•	At 52 weeks, 100% of subjects (n=4) reported a >30% improvement in VAS versus baseline (n=4);

•	At 12 and 26 weeks, 70% of subjects (n=10) had a >30% improvement in ODI versus baseline;

•	At 52 weeks, 100% of subjects (n=4) had a >30% improvement in ODI versus baseline; and

•	At 26 weeks, 70% of subjects (n=10) reported a >30% decrease in pain (VAS) and a >30% increase in function (ODI).

“Blinded preliminary clinical data of safety and efficacy endpoints from the ongoing Phase 2 clinical trial of BRTX-100 in the treatment of cLDD are very encouraging, with patient reported pain and function outcomes demonstrating a positive trend,” said Lance Alstodt, Chief Executive Officer of BioRestorative. “Most importantly, at 26 weeks 70% of the patients are reporting a greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, we are confident that we will hit our efficacy end points for the Phase 2 trial.”

This new blinded preliminary safety and efficacy data from the ongoing Phase 2 clinical trial of BRTX-100 will be described in podium presentation later today at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium, taking place in Skytop, Pennsylvania. BioRestorative management will also host a webcasted conference call with an associated slide presentation today at 4:30pm EST to review the BRTX-100 data, as well as review its third quarter 2024 financial results and provide a business update.

Conference Call & Webcast Details

To join the conference call via phone and participate in the live Q&A session, please dial 877-545-0320 (United States) or 973-528-0002 (International), participant access code 823128. The live webcast (with slides) 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 BioRestorative Therapies, Inc.

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, as amended, and Form 10-Q 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:

Stephen Kilmer

Investor Relations

Direct: (646) 274-3580

Email: skilmer@biorestorative.com

EX-99.3 7 ex99_3.htm PRESENTATION MATERIALS

Ex 99.3