Welcome to our dedicated page for BioRestorative Therapies news (Ticker: BRTX), a resource for investors and traders seeking the latest updates and insights on BioRestorative Therapies stock.
BioRestorative Therapies, Inc. (NASDAQ: BRTX) is a cutting-edge biotechnology company based in the United States, dedicated to developing regenerative medicine products and therapies using cell and tissue protocols, particularly involving adult stem cells. The company’s core focuses are its Disc/Spine Program and Metabolic Program.
In the Disc/Spine Program, their lead cell therapy candidate, BRTX-100, is formulated from autologous cultured mesenchymal stem cells collected from the patient's bone marrow. This innovative treatment is designed for the non-surgical management of protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. BRTX-100 undergoes a meticulous production process, starting from the collection of a patient’s bone marrow, followed by the isolation and culturing of stem cells, and finally cryopreserving these cells. The therapy involves injecting BRTX-100 into the patient's damaged disc, offering hope for patients whose pain has not been alleviated by other non-invasive treatments.
The Metabolic Program focuses on developing cell-based therapies to combat obesity and metabolic disorders using brown adipose-derived stem cells. This innovative approach aims to generate brown adipose tissue to help address these widespread health issues.
BioRestorative Therapies is also venturing into the rapidly growing bio-cosmeceutical market. The company recently signed a five-year exclusive supply agreement with Cartessa Aesthetics, LLC, a prominent North American aesthetics company. This partnership aims to introduce proprietary cell-based innovations to the aesthetics market, leveraging both BioRestorative’s expertise in cell-based biologics and Cartessa’s strong market presence.
Financially, BioRestorative is strong, ending 2023 with around $11.1 million in cash and cash equivalents, and an additional $7.6 million from a recent private placement. This solid financial standing, combined with expected revenues from its new commercial products, allows the company to pursue further advancements in their clinical and preclinical pipelines, including their BRTX-100 and ThermoStem® programs.
For more information, visit BioRestorative Therapies or contact Investor Relations at ir@biorestorative.com.
BioRestorative Therapies (NASDAQ:BRTX) has received a Notice of Allowance from the European Patent Office for a new patent application covering their ThermoStem® metabolic disease platform. The patent (No. 20798130.9) protects the method of creating non-naturally occurring three-dimensional brown adipose derived stem cell aggregates and is expected to provide protection until April 29, 2040.
The company is developing an exosome-based biologic program targeting obesity and plans to initiate the FDA process by filing a Drug Master File. BioRestorative is currently in discussions with an unnamed commercial stage regenerative medicine company regarding potential licensing of their ThermoStem® metabolic intellectual property, though no agreement has been finalized.
BioRestorative Therapies announced promising preliminary data from its Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease. The blinded data from the first 10 patients showed significant improvements in pain reduction and function increase. At 26 weeks, 70% of subjects reported >30% improvement in both pain (VAS) and function (ODI). At 52 weeks, 100% of subjects (n=4) showed >30% improvement in both metrics. No serious adverse events were reported, and there was no dose limiting toxicity at 26-52 weeks. The ongoing trial will enroll up to 99 subjects across 16 U.S. clinical sites, randomized 2:1 for BRTX-100 or placebo.
BioRestorative Therapies (NASDAQ:BRTX) reported its Q3 2024 financial results, showing improved operational performance with a reduced loss from operations of $2.3 million, down 26% year-over-year. The company generated $230,700 in product revenue from its supply agreement with Cartessa Aesthetics. Key developments include receiving a provisional license from NYSDOH for allogeneic tissue processing and advancing its BRTX-100 Phase 2 clinical trial for chronic lumbar disc disease. The company maintains a strong financial position with $13.1 million in cash and investments, with no outstanding debt as of September 30, 2024.
BioRestorative Therapies (NASDAQ:BRTX) announces upcoming presentation of new preliminary data from its Phase 2 clinical trial of BRTX-100 at the ORS PSRS 7th International Spine Research Symposium. The presentation will include 26-52 week blinded safety and efficacy data from a larger patient group than previously reported in their chronic lumbar disc disease (cLDD) study. The Phase 2 trial is a randomized, double-blinded study enrolling up to 99 subjects across 16 U.S. clinical sites. The company will also release Q3 2024 financial results and host a conference call on November 13, 2024.
BioRestorative Therapies (BRTX) has received a provisional license from the New York State Department of Health for processing allogeneic donor tissue material. This expanded license allows for the isolation, expansion, and cryopreservation of various cell types, including stem cells, for medical research. Previously, BRTX was only licensed for processing mesenchymal stem cells from autologous donors. The new license enables the company to process, bank, and distribute clinical grade allogeneic biologics using its cGMP manufacturing capabilities. NYSDOH licensure requires compliance with regulations ensuring safe and ethical tissue handling through comprehensive facility inspections.
BioRestorative Therapies has received a Notice of Allowance from the Israel Patent Office for its ThermoStem® technology platform. This marks the 14th international patent outside the U.S. for this technology. The patent covers brown adipose derived stem cell (BADSC) aggregates, encapsulation systems, and treatment methods. The company believes ThermoStem®-based BADSCs could offer better efficacy and tolerability compared to GLP-1 drugs. In May 2024, BioRestorative announced development of an exosome-based biologic program targeting obesity and plans to file a Drug Master File with the FDA. The company is also in discussions with an undisclosed regenerative medicine company regarding potential licensing of ThermoStem® intellectual property.
BioRestorative Therapies (NASDAQ: BRTX), a regenerative medicine company specializing in stem cell-based therapies, has announced its participation in two upcoming investor events in October 2024:
1. UBS Virtual Organ Restoration and Cell Therapy Day: CEO Lance Alstodt will engage in a fireside chat with UBS analyst Ash Verma on October 15, 2024, at 1:00 p.m. ET.
2. 2024 Maxim Healthcare Virtual Summit: Alstodt will participate in another fireside chat with Jason McCarthy, Ph.D., Maxim Group's Head of Biotechnology Research, on October 17, 2024, at 11:00 a.m. ET.
These events provide opportunities for BRTX to showcase its innovative stem cell-based therapies and products to potential investors and industry experts.
BioRestorative Therapies (NASDAQ:BRTX), a regenerative medicine company specializing in stem cell-based therapies, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference. The event is scheduled for October 9, 2024 in New York City.
CEO Lance Alstodt will represent the company at the conference, which will primarily consist of one-on-one investor meetings. Investors attending the conference who wish to meet with BioRestorative are advised to contact their ROTH MKM sales representative to arrange a meeting.
This participation provides an opportunity for BioRestorative to engage directly with investors and showcase its innovative work in stem cell-based therapies and products.
BioRestorative Therapies (NASDAQ:BRTX) announced that its Chief Scientist, Francisco Silva, will present at the 21st Annual IFATS Conference. The presentation will focus on the ThermoStem® platform's potential to deliver superior efficacy and tolerability compared to GLP-1 drugs for obesity treatment. Preclinical data showed significant reductions in weight, triglycerides, and blood glucose levels using BioRestorative's brown adipose-derived stem cells and 3D scaffold technology. The company believes its cell-based therapy may allow for lower dosing and avoid the lean muscle mass loss associated with GLP-1 drugs. BioRestorative is also developing a novel exosome-based biologic program targeting obesity and has begun discussions with a regenerative medicine company regarding potential licensing of its ThermoStem® intellectual property.
BioRestorative Therapies (NASDAQ:BRTX) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Improved financial performance: Loss from operations decreased 19% YoY to $2.5 million, while net loss improved 28% YoY to $4.0 million ($0.50 per share).
2. Strong cash position: $14.7 million in cash, cash equivalents, and marketable securities as of June 30, 2024, with no outstanding debt.
3. Progress in clinical programs: FDA clearance for protocol amendment in BRTX-100 Phase 2 study; development of novel exosome-based biologic program for obesity.
4. Commercial developments: Exclusive 5-year agreement with Cartessa Aesthetics for BioCosmeceuticals product supply, generating initial revenue in Q2 2024.
5. Intellectual property expansion: Notice of allowance for Japanese patent related to ThermoStem® platform.
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