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BioRestorative Therapies’ IFATS 2024 Presentation to Feature ThermoStem® Platform’s Potential to Deliver a Superior Efficacy and Tolerability Profile Over GLP-1 Drugs

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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) ha annunciato che il suo Chief Scientist, Francisco Silva, presenterà alla 21ª Conferenza Annuale IFATS. La presentazione si concentrerà sul potenziale della piattaforma ThermoStem® di offrire una maggiore efficacia e tollerabilità rispetto ai farmaci GLP-1 per il trattamento dell'obesità. I dati preclinici hanno mostrato significativi riduzioni del peso, dei trigliceridi e dei livelli di glucosio nel sangue utilizzando le cellule staminali derivate dal tessuto adiposo bruno di BioRestorative e la tecnologia 3D scaffold. L'azienda ritiene che la sua terapia cellulare possa consentire dosi inferiori ed evitare la perdita di massa muscolare magra associata ai farmaci GLP-1. BioRestorative sta inoltre sviluppando un nuovo programma biologico basato su esosomi mirato all'obesità e ha avviato discussioni con un'azienda di medicina rigenerativa riguardo a una potenziale licenza della sua proprietà intellettuale ThermoStem®.

BioRestorative Therapies (NASDAQ:BRTX) anunció que su Científico Jefe, Francisco Silva, presentará en la 21ª Conferencia Anual IFATS. La presentación se centrará en el potencial de la plataforma ThermoStem® para ofrecer una mayor eficacia y tolerancia en comparación con los medicamentos GLP-1 para el tratamiento de la obesidad. Los datos preclínicos mostraron reducciones significativas en el peso, los triglicéridos y los niveles de glucosa en sangre utilizando las células madre derivadas de tejido adiposo marrón de BioRestorative y la tecnología de andamios 3D. La empresa cree que su terapia celular podría permitir una dosificación más baja y evitar la pérdida de masa muscular magra asociada con los medicamentos GLP-1. BioRestorative también está desarrollando un novedoso programa biológico basado en exosomas dirigido a la obesidad y ha comenzado conversaciones con una empresa de medicina regenerativa sobre una posible licencia de su propiedad intelectual ThermoStem®.

BioRestorative Therapies (NASDAQ:BRTX)는 최고 과학자인 Francisco Silva가 제21회 연례 IFATS 회의에서 발표할 것이라고 발표했습니다. 발표는 비만 치료를 위한 GLP-1 약물에 비해 우수한 효능과 내약성을 제공할 수 있는 ThermoStem® 플랫폼의 잠재력에 초점을 맞출 것입니다. 전임상 데이터는 BioRestorative의 갈색 지방 유래 줄기 세포와 3D 스캐폴드 기술을 사용하여 체중, 중성지방 및 혈당 수치에서 상당한 감소를 보여주었습니다. 회사는 이 세포 기반 치료법이 용량을 줄이고 GLP-1 약물과 관련된 손실을 피할 수 있을 것이라고 믿고 있습니다. BioRestorative는 또한 비만을 겨냥한 엑소좀 기반 생리학 프로그램을 개발하고 있으며, ThermoStem® 지적 재산의 잠재적 라이센스에 관한 재생 의학 회사와의 논의를 시작했습니다.

BioRestorative Therapies (NASDAQ:BRTX) a annoncé que son scientifique en chef, Francisco Silva, fera une présentation lors de la 21e conférence annuelle IFATS. La présentation se concentrera sur le potentiel de la plateforme ThermoStem® à offrir une efficacité et une tolérance supérieures par rapport aux médicaments GLP-1 pour le traitement de l'obésité. Les données précliniques ont montré des réductions significatives du poids, des triglycérides et des niveaux de glucose sanguin en utilisant des cellules souches dérivées de tissu adipeux brun de BioRestorative et la technologie de support 3D. L'entreprise pense que sa thérapie basée sur les cellules pourrait permettre une posologie plus faible et éviter la perte de masse musculaire maigre associée aux médicaments GLP-1. BioRestorative développe également un nouveau programme biologique basé sur des exosomes ciblant l'obésité et a commencé des discussions avec une entreprise de médecine régénérative concernant une éventuelle licence de sa propriété intellectuelle ThermoStem®.

BioRestorative Therapies (NASDAQ:BRTX) gab bekannt, dass sein Chief Scientist, Francisco Silva, auf der 21. Internationalen IFATS-Konferenz präsentieren wird. Die Präsentation wird sich auf das Potenzial der ThermoStem®-Plattform konzentrieren, eine überlegene Wirksamkeit und Verträglichkeit im Vergleich zu GLP-1-Arzneimitteln zur Behandlung von Fettleibigkeit zu bieten. Präklenische Daten zeigten signifikante Reduktionen des Gewichts, der Triglyceride und der Blutzuckerwerte unter Verwendung der braunen Fettgewebe-stammzellen von BioRestorative und der 3D-Scaffold-Technologie. Das Unternehmen glaubt, dass seine zellbasierte Therapie eine niedrigere Dosierung ermöglichen und den Verlust von fettfreier Muskelmasse, der mit GLP-1-Arzneimitteln verbunden ist, vermeiden könnte. BioRestorative entwickelt auch ein neuartiges exosomales biologisches Programm zur Bekämpfung von Fettleibigkeit und hat Gespräche mit einem Unternehmen für regenerative Medizin über eine mögliche Lizenzierung seines geistigen Eigentums von ThermoStem® begonnen.

Positive
  • Preclinical data shows significant weight, triglyceride, and blood glucose reductions using BioRestorative's technology
  • ThermoStem® platform potentially offers superior efficacy and tolerability over GLP-1 drugs for obesity treatment
  • Development of a novel exosome-based biologic program targeting obesity
  • Ongoing discussions with a commercial stage regenerative medicine company for potential licensing of ThermoStem® IP
Negative
  • No assurances given that a license agreement will be entered into for the ThermoStem® technology

MELVILLE, N.Y., Sept. 19, 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 that its Chief Scientist and Vice President of Research and Development, Francisco Silva, will present at the 21st Annual International Federation for Adipose Therapeutics and Science (“IFATS”) Conference being held in Pittsburgh, PA from September 19-22, 2024.

Presentation Details

Title: Brown Adipose Derived Mesenchymal Stem Cells (BADSCs), a Cell-Based Therapeutic as an Alternative to Glucagon-like Peptide-1 (GLP-1) Agonists to Treat Obesity

Date and Time: Sunday, September 22nd; 9:50-10:00am ET

Session: Free Papers - Adipose Stem Cell Phenotype and Cell-Based Therapies

“Previously published peer-reviewed preclinical data obtained in high-fat fed NOD-SCID mice transplanted with differentiated multipotent brown adipose derived stem cells supported by a BioRestorative-developed 3D Porous Extracellular Matrix-Derived Scaffold showed significant reductions in weight (consistent with losses achieved by GLP-1 drugs), triglyceride and blood glucose levels compared to saline-only injected controls,” commented Mr. Silva. “The study also demonstrated that BioRestorative’s 3D scaffold was capable of retaining viable transplanted cells for at least five weeks post-implantation.”

Mr. Silva continued, “We believe that cell-based therapy candidates generated from our ThermoStem® metabolic disease 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. We are excited to be afforded the opportunity to share the details of this exciting brown fat stem cell technology platform at IFATS 2024.”

In May 2024, BioRestorative revealed the development of a novel exosome-based biologic program targeting obesity, advising that the Company plans to initiate the formal U.S. Food and Drug Administration (FDA) process for this ThermoStem®-based therapeutic candidate by filing a Drug Master File (DMF). On the heels of that announcement, BioRestorative reported that it had begun to engage in substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license of BioRestorative’s allogeneic, off-the-shelf ThermoStem® metabolic intellectual property. Those discussions are continuing; however, no assurances can be given that a license agreement will be entered into whether on commercially reasonable terms or otherwise.

About IFATS 2024

The International Federation for Adipose Therapeutics and Science is the premier, global scientific society focused on promoting research on adipose biology and adipose-derived therapeutics. The annual conference, which began in 2003, has a rich tradition in being multi-perspective and features innovations in basic science, translational research, clinical and surgical practice, and industry-led initiatives. Annual features of the conference include regulatory and legal issues pertinent to regenerative therapeutics, clinician-driven therapeutic translation, basic science investigations in therapeutic mechanisms of action, and industry-academia commercialization partnerships.

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 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


FAQ

What is BioRestorative Therapies (BRTX) presenting at IFATS 2024?

BioRestorative Therapies (BRTX) is presenting on their ThermoStem® platform's potential to deliver superior efficacy and tolerability compared to GLP-1 drugs for obesity treatment, featuring their brown adipose-derived stem cells and 3D scaffold technology.

How does BioRestorative's ThermoStem® technology compare to GLP-1 drugs for obesity?

BioRestorative's ThermoStem® technology potentially offers lower dosing and avoids the 20-40% lean muscle mass loss associated with GLP-1 drugs. Preclinical studies show significant reductions in weight, triglycerides, and blood glucose levels.

What new program is BioRestorative Therapies (BRTX) developing for obesity treatment?

BioRestorative Therapies (BRTX) is developing a novel exosome-based biologic program targeting obesity, with plans to initiate the FDA process by filing a Drug Master File (DMF).

Is BioRestorative Therapies (BRTX) in talks to license its ThermoStem® technology?

Yes, BioRestorative Therapies (BRTX) is in discussions with an undisclosed commercial stage regenerative medicine company regarding potential licensing of its ThermoStem® metabolic intellectual property, though no agreement is guaranteed.

BioRestorative Therapies, Inc.

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