Revenue and Profitability - For the three months ended June 30, 2024, revenues were $89,100, compared to $64,500 for the same period in 2023, representing an increase of 38.2%[68] - Gross profit for the three months ended June 30, 2024, was $82,610, up from $64,500 in 2023, indicating a significant improvement in profitability[68] - Revenues for the six months ended June 30, 2024, increased to $124.1 million from $95.8 million in 2023, representing a growth of 29.5%[75] - Gross profit for the same period rose to $117.6 million, compared to $95.8 million in 2023, indicating a significant increase[75] Expenses - Research and development expenses increased by $389,291, or 43%, to $1,292,182 for the three months ended June 30, 2024, compared to $902,891 in 2023[69] - General and administrative expenses decreased by $1,018,925, or 45%, to $1,259,235 for the three months ended June 30, 2024, primarily due to a reduction in stock-based compensation[70] - Research and development expenses increased by $215,677, or 10%, to $2,350,313 for the six months ended June 30, 2024, primarily due to higher lab supply and payroll expenses[77] - General and administrative expenses decreased by $2,511,457, or 37%, to $4,345,356, mainly due to a reduction in stock-based compensation[77] Income and Loss - Interest income rose to $175,945 for the three months ended June 30, 2024, compared to $96,187 in the same period of 2023, reflecting improved returns on marketable securities[71] - The net loss for the three months ended June 30, 2024, was $4,028,562, a decrease from a net loss of $5,709,399 in 2023, indicating a reduction in losses[68] - Interest income increased to $338,542 for the six months ended June 30, 2024, compared to $114,403 in 2023, driven by investments in marketable securities[78] Cash Flow and Working Capital - Cash and cash equivalents increased to $2,252,247 as of June 30, 2024, up from $884,377 at the end of 2023[79] - Working capital improved by $900,754 to $9,683,935, supported by $7,505,646 in cash from financing activities[79] - Net cash used in operating activities was $4,182,945 for the six months ended June 30, 2024, compared to $3,662,831 in 2023[84] - Net cash provided by financing activities was $7,505,646 for the six months ended June 30, 2024, a significant increase from $411,701 in 2023[89] Business Development - The company generated $69,300 in cosmetic product sales revenue in connection with its exclusive supply agreement with Cartessa for the three months ended June 30, 2024[69] - The company expects an increase in royalty revenue from its sublicense agreement with SCTC in future periods due to anticipated growth in disc procedures[68] - The company has received FDA authorization to commence a Phase 2 clinical trial for BRTX-100, targeting chronic lower back pain from degenerative disc disease[63] - The company is developing a biologics-based cosmetic products business and has entered into a five-year exclusive supply agreement with Cartessa Aesthetics[65] Gains - The company recognized a gain on exchange of warrants amounting to $1,711,698 for the six months ended June 30, 2024[78]

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): August 13, 2024 BioRestorative Therapies, Inc. (Exact name of registrant as specified in its charter) | --- | --- | --- | |--------------------------------------------------------|------------------------------------------------------------------|---------------------------------------| | Nevad ...

"I am deeply honored to have been selected to help launch this important new special section of the Journal of Translational Medicine," Mr. Silva said. "Today, most regenerative medicine research remains confined to the bench rather than the bedside. But if our cell-based therapy development progress at BioRestorative, as well as that at several other companies, is any indication, it may not be long before the full clinical potential of the field is realized. I am energized by this unique opportunity to wor ...

Core Insights - BioRestorative Therapies, Inc. has appointed Francisco Silva as the Section Editor for the newly launched Regenerative Medicine section of the Journal of Translational Medicine, highlighting the company's commitment to advancing research in regenerative medicine [2][15]. Company Overview - BioRestorative Therapies, Inc. is a clinical-stage company focused on developing stem cell-based therapies, particularly targeting musculoskeletal and metabolic disorders [15][17]. - The company operates two core clinical development programs: the Disc/Spine Program (brtxDISC™) and the Metabolic Program (ThermoStem®), along with a commercial BioCosmeceutical platform [5][11][17]. Research and Development - Francisco Silva has extensive experience in developing cell-based therapeutics and is currently leading a Phase 2 study for BRTX-100, aimed at treating chronic lumbar disc disease [9][11]. - The Metabolic Program utilizes brown adipose derived stem cells (BADSC) to develop therapies targeting obesity and metabolic disorders, with initial preclinical research indicating potential benefits in caloric burning and metabolic regulation [5][12]. Product Offerings - The BRTX-100 product is formulated from autologous cultured mesenchymal stem cells and is intended for non-surgical treatment of painful lumbosacral disc disorders [11]. - The BioCosmeceutical platform includes a proprietary biologic serum designed to reduce fine lines and wrinkles, with plans to expand the product line through FDA approvals [6][17]. Journal Impact - The Journal of Translational Medicine, where the new section will be featured, has a 2021 impact factor of 8.440, ranking it among the top 3% of journals globally, indicating a strong platform for disseminating research in regenerative medicine [8].

Core Insights - BioRestorative Therapies, Inc. has received a notice of allowance from the Japanese Patent Office for a patent related to its ThermoStem® platform, enhancing its intellectual property portfolio [6][7] - The company is actively expanding its ThermoStem® intellectual property estate to secure long-term market exclusivity for its BADSCs, which are aimed at treating obesity and metabolic disorders [2][11] - BioRestorative is engaged in substantive discussions with a commercial stage regenerative medicine company regarding a potential licensing agreement for its ThermoStem® metabolic intellectual property [12] Company Overview - BioRestorative develops therapeutic products using adult stem cells, focusing on two main clinical programs: treatment of disc/spine disease and metabolic disorders [3] - The company operates a commercial BioCosmeceutical platform, offering a cell-based secretome product designed to reduce fine lines and wrinkles, with plans to expand its product line [4] Metabolic Program - The ThermoStem® program utilizes brown adipose derived stem cells (BADSC) to generate brown adipose tissue (BAT), which is linked to increased caloric burning and reduced glucose and lipid levels [9] - Preclinical studies indicate that BADSCs can lead to significant reductions in weight, triglyceride, and blood glucose levels in animal models [11] Disc/Spine Program - The lead therapy candidate, BRTX-100, is formulated from a patient's own mesenchymal stem cells and is intended for non-surgical treatment of lumbosacral disc disorders [13] - A Phase 2 clinical trial for BRTX-100 has commenced, targeting chronic lower back pain due to degenerative disc disease [13]

Core Insights - BioRestorative Therapies, Inc. has regained compliance with Nasdaq Listing Rule 5250(c)(1) after filing its Quarterly Report for Q1 2024 [1] - The company reported a significant year-over-year improvement in its financial performance for the first quarter of 2024 [10] Financial Performance - For Q1 2024, the company had a loss from operations of $4.1 million, which is a 29% improvement from the $5.8 million loss in Q1 2023 [2] - The net loss for Q1 2024 was $2.2 million, or $0.33 per share, compared to a net loss of $7.2 million, or $1.93 per share, in the same period of 2023 [2] - Cash used in operating activities was $2.3 million in Q1 2024, slightly down from $2.4 million in Q1 2023 [3] - The company ended Q1 2024 with a strong financial position, holding $16.4 million in cash, cash equivalents, and marketable securities [3][4] Business Overview - BioRestorative focuses on developing therapeutic products using adult stem cells, with two core clinical development programs: the Disc/Spine Program and the Metabolic Program [4][5] - The Disc/Spine Program includes BRTX-100, a cell therapy candidate for treating painful lumbosacral disc disorders, currently in Phase 2 clinical trials [4] - The Metabolic Program, known as ThermoStem®, aims to target obesity and metabolic disorders using brown adipose-derived stem cells [5] - The company also operates a commercial BioCosmeceutical platform, offering a cell-based secretome product designed to reduce fine lines and wrinkles [6]

- Potential license partner is a leading commercial stage regenerative medicine company – No assurances can be given that a license agreement will be entered into whether on commercially reasonable terms or otherwise. The Company does not intend to make any further announcements with regard to the license unless and until an agreement is entered into. • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's own) cultured mesenchymal ...

BADSCs with brown adipogenic potential would represent an exciting new modality for the treatment of obesity and related metabolic disorders. To explore this possibility, BioRestorative developed a 3D Porous Extracellular Matrix-Derived Scaffold for effective cell delivery. Data obtained in high-fat fed NOD-SCID mice transplanted with differentiated BADSCs supported by the 3D scaffold showed significant reductions in weight, triglyceride and blood glucose levels compared to saline-only injected controls. No ...

Company Performance - Biorestorative Therapies reported revenues of $0.04 million for the quarter ended March 2024, exceeding the Zacks Consensus Estimate by 16.67% and up from $0.03 million year-over-year [2] - The company posted a quarterly loss of $0.53 per share, compared to the Zacks Consensus Estimate of a loss of $0.51, and a loss of $1.53 per share a year ago [8] - Biorestorative Therapies has surpassed consensus EPS estimates three times over the last four quarters [9] Stock Performance - Biorestorative Therapies shares have declined approximately 32.8% since the beginning of the year, while the S&P 500 has gained 12.4% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.46 on revenues of $0.03 million, and for the current fiscal year, it is -$1.96 on revenues of $0.12 million [5] Industry Context - The Medical - Biomedical and Genetics industry, to which Biorestorative Therapies belongs, is currently ranked in the top 32% of over 250 Zacks industries, indicating a favorable outlook [13] - The performance of Biorestorative Therapies may be influenced by the overall industry outlook, as top-ranked industries tend to outperform lower-ranked ones significantly [13]

For the Three Months Ended March 31, 2023 Series B Convertible Additional Preferred Stock Common Stock Paid-In Accumulated Shares Amount Shares Amount Capital Deficit Total | --- | --- | --- | --- | --- | --- | --- | --- | --- | |----------------------------------------------------------------------------------------|-----------|------------|-----------|-------|-------|--------------|----------------|---------------| | Return and cancellation of shares in lieu of payroll tax \nwithholding | - | - | (10,058) ...