BioRestorative Therapies, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>BioRestorative Therapies, Inc. has filed its 2023 annual report (10-K) detailing its financial status and business operations.</b>

AI Summary

BioRestorative Therapies, Inc. (BRTX) filed a Annual Report (10-K) with the SEC on April 1, 2024. BioRestorative Therapies, Inc. filed its annual report for the fiscal year ended December 31, 2023. The filing is a Form 10-K, indicating a comprehensive overview of the company's financial performance and condition. The company's principal business address is 40 Marcus Drive, Melville, NY 11747. BioRestorative Therapies, Inc. was formerly known as Stem Cell Assurance, Inc. until November 10, 2010. The SIC code for the company is 8090, categorized under Services-Misc Health & Allied Services, NEC.

Why It Matters

For investors and stakeholders tracking BioRestorative Therapies, Inc., this filing contains several important signals. This 10-K filing provides investors with a detailed look at the company's financial health, operational performance, and strategic direction for the fiscal year 2023. Understanding the information within this report is crucial for assessing the company's current standing and future prospects, including any potential risks or opportunities.

Risk Assessment

Risk Level: medium — BioRestorative Therapies, Inc. shows moderate risk based on this filing. The company's business is highly dependent on the success of its research and development efforts, which are subject to significant risks and uncertainties, including regulatory approvals and market acceptance, as indicated by the nature of a biotechnology company filing a 10-K.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess the company's operational progress and potential for future growth in the biotechnology sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported fiscal year end)
• 2024-04-01 — Filing Date (Date the 10-K was filed)
• 8090 — SIC Code (Standard Industrial Classification code)
• 001-37603 — SEC File Number (SEC file number for the company)

Key Players & Entities

• BioRestorative Therapies, Inc. (company) — Filer name
• Stem Cell Assurance, Inc. (company) — Former company name
• 40 Marcus Drive, Melville, NY 11747 (company) — Business address
• 20231231 (date) — Fiscal year end
• 20240401 (date) — Filing date

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company's operations are subject to extensive regulation by governmental agencies, which can impact product development, manufacturing, and marketing.
• Need for Additional Financing [high — financial]: The company may require additional capital to fund its operations and research and development activities, and there is no assurance that such financing will be available on favorable terms.
• Dependence on Key Personnel [medium — operational]: The success of the company depends significantly on the continued service of its key management and scientific personnel.
• Market Acceptance of Products [medium — market]: The commercial success of the company's products depends on market acceptance, which is uncertain and subject to various factors.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-04-01: Filing Date — Date the 10-K was officially filed with the SEC.

Key Financial Figures

• $0.0001 — ange on which registered Common Stock $0.0001 par value BRTX Nasdaq Capital Mark
• $6,109,000 — ng an aggregate offering price of up to $6,109,000. To date, we have sold approximately $6
• $622,000 — 00. To date, we have sold approximately $622,000 of our shares pursuant to the Sales Agr
• $2,100,000 — eceived gross proceeds of approximately $2,100,000 from the offering. In September 2023,
• $8,100,000 — eceived gross proceeds of approximately $8,100,000 from the warrant exercise. (b) Busine
• $23,000,000 — date. In November 2021, we completed a $23,000,000 public offering of our securities. In 2
• $2,680,000 — ities. In 2023, we raised approximately $2,680,000 in additional gross proceeds through pu
• $40 billion — that such procedures cost approximately $40 billion. Clinical studies have documented that
• $110,000 — al fusion surgery costing approximately $110,000, discectomy costing approximately $20,0
• $20,000 — 0,000, discectomy costing approximately $20,000 to $50,000 and disc replacement surgery
• $50,000 — ectomy costing approximately $20,000 to $50,000 and disc replacement surgery costing ap
• $80,000 — placement surgery costing approximately $80,000 to $150,000. Even conservative treatmen
• $150,000 — urgery costing approximately $80,000 to $150,000. Even conservative treatments can be co
• $1,000 — , with oral medications costing between $1,000 and $2,000 per year, injection treatmen
• $2,000 — medications costing between $1,000 and $2,000 per year, injection treatments costing

Filing Documents

• form10-k.htm (10-K) — 2126KB
• ex10-7.htm (EX-10.7) — 175KB
• ex10-12.htm (EX-10.12) — 142KB
• ex10-27.htm (EX-10.27) — 152KB
• ex10-36.htm (EX-10.36) — 57KB
• ex10-37.htm (EX-10.37) — 57KB
• ex10-38.htm (EX-10.38) — 57KB
• ex10-39.htm (EX-10.39) — 57KB
• ex10-40.htm (EX-10.40) — 55KB
• ex10-41.htm (EX-10.41) — 55KB
• ex10-42.htm (EX-10.42) — 55KB
• ex23.htm (EX-23) — 4KB
• ex31-1.htm (EX-31.1) — 16KB
• ex31-2.htm (EX-31.2) — 16KB
• ex32.htm (EX-32) — 9KB
• ex97.htm (EX-97.1) — 46KB
• form10-k_001.jpg (GRAPHIC) — 24KB
• form10-k_002.jpg (GRAPHIC) — 56KB
• form10-k_003.jpg (GRAPHIC) — 42KB
• form10-k_004.jpg (GRAPHIC) — 2KB
• form10-k_005.jpg (GRAPHIC) — 44KB
• 0001493152-24-012056.txt (&nbsp;) — 9197KB
• brtx-20231231.xsd (EX-101.SCH) — 38KB
• brtx-20231231_cal.xml (EX-101.CAL) — 60KB
• brtx-20231231_def.xml (EX-101.DEF) — 189KB
• brtx-20231231_lab.xml (EX-101.LAB) — 370KB
• brtx-20231231_pre.xml (EX-101.PRE) — 301KB
• form10-k_htm.xml (XML) — 1267KB

Forward-Looking Statements

Forward-Looking Statements 3 PART I 3 Item 1. Business. 3 Item 1A. Risk Factors. 35 Item 1B. Unresolved Staff Comments. 67 Item 1C. Cybersecurity. 67 Item 2. Properties. 68 Item 3. Legal Proceedings. 68 Item 4. Mine Safety Disclosures. 68 PART II 69 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. 69 Item 6. [Reserved]. 69 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations. 69 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk. 77 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data. 77 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. 77 Item 9A.

Controls and Procedures

Controls and Procedures. 77 Item 9B. Other Information. 79 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 79 PART III 80 Item 10. Directors, Executive Officers and Corporate Governance. 80 Item 11.

Executive Compensation

Executive Compensation. 85 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 88 Item 13. Certain Relationships and Related Transactions, and Director Independence. 90 Item 14. Principal Accountant Fees and Services. 91 PART IV 92 Item 15. Exhibits and Financial Statement Schedules. 92 Item 16. Form 10-K Summary. 95

Signatures

Signatures 96 2 PART I Forward-Looking This Annual Report contains forward-looking statements as that term is defined in the federal securities laws. The events described in forward-looking or anticipated benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions to be made by us, or projections involving anticipated revenues, earnings or other aspects of our operating results. The words "may," "will," "expect," "believe," "anticipate," "project," "plan," "intend," "estimate," and "continue," and their opposites and similar expressions are intended to identify forward-looking statements. We caution you that these statements are not guarantees of future performance or events and are of the statements and the projections upon which the statements are based. Factors which may affect our results include, but are not limited to, the risks and uncertainties discussed in Item 1A of this Annual Report ("Risk Factors"). Any one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking those expressed or implied in these forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking Intellectual Property This Annual Report includes references to our federally registered trademarks, BioRestorative Therapies and Dragonfly design, BRTX-100 , ThermoStem and BRTX . The Dragonfly logo is also registered with the U.S. Copy

Business

Business General We develop 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, or MSCs, 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 complimentary 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-surgical procedures and who potentially face the prospect of surgery. We have received authorization from the FDA to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have commenced such clinical trial through the execution of a CRO agreement with PRC Clinical, the execution of clinical trial site agreements, patient enrollment, the commencement of patient procedures, the purchase of manufacturing equipment and the expansion of our laboratory to include capabilities for clinical production. In March 2022, a United States patent related to our Disc/Spine Program was issued. We have been granted exclusive license rights with regard to the patent. See "Disc/Spine Program" below. 5 Metabolic Program (ThermoStem) . We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells, or BADSC, to generate brown adipose tissue, or BAT. W

View Full Filing

View this 10-K filing on SEC EDGAR