Latest news with #BRTX
Yahoo
17-06-2025
- Business
- Yahoo
BioRestorative Announces Share Repurchase Program
MELVILLE, N.Y., June 17, 2025 (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 Board of Directors has authorized a stock repurchase program under which the Company may repurchase up to $2 million of its outstanding common stock through June 16, 2026. "This share repurchase program reflects our confidence in the strength of our clinical development pipeline and the future outlook of our business,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'There is no question in our minds that BioRestorative has great science, assets and people. As such, we believe our current share price does not reflect the intrinsic value of the company, particularly in light of our recent clinical and operational progress. Accordingly, we believe this program provides us with an opportunity to enhance long-term shareholder value.' The repurchases may be made from time to time in the open market, through privately negotiated transactions, or by other means in accordance with applicable securities laws. The timing, number, and value of shares repurchased under the program will be at the discretion of the Company's management and will depend on a variety of factors, including market conditions, share price, and other corporate considerations. The share repurchase program may be modified, suspended or terminated at any time at the Company's discretion and does not obligate the Company to acquire any amount of common stock. About BioRestorative Therapies, Inc. BioRestorative ( 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 also operate a commercial BioCosmeceutical platform: • 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. We have also obtained U.S. Food and Drug Administration ('FDA') Investigational New Drug ('IND') clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain. • 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 IND-enabling studies, with the aim of pioneering 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 KilmerInvestor RelationsDirect: (646) 274-3580 Email: skilmer@
Yahoo
10-06-2025
- Business
- Yahoo
BioRestorative Welcomes Serial Regenerative Medicine Entrepreneur, Company Builder and Leader, Sandy Lipkins, to BRTX Team
MELVILLE, N.Y., June 10, 2025 (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, announced today its hiring of Industry leader, Sandy Lipkins, to focus on technology commercialization and business development, effective June 9, 2025. In his role, Mr. Lipkins will be responsible for sourcing, structuring, negotiating and executing strategic alliances and licensing/co-development agreements for BioRestorative domestically and internationally, as well as providing new product and sales expertise to the Company. Mr. Lipkins has an accomplished record of business development success within the healthcare industry. He brings over 30 years of venture capital, finance, and sales experience, with deep expertise in the anti-aging and wellness sectors. His extensive work and network in stem cells, regenerative medicine, and tissue banking have helped drive the development of a number of cutting-edge therapies. In addition, Mr. Lipkin's executive experience in scaling, compounding and biologics manufacturing, as well as his proven ability to expand market reach, has been pivotal to company growth. Mr. Lipkins is passionate about promoting anti-aging, healthy lifestyle and bringing cutting-edge regenerative medicine to the critical masses, domestically and internationally. He has taken companies from incubation, to revenue generation and growth, to setting up for sale or other liquidity events. 'We are absolutely thrilled to welcome Sandy to BioRestorative Therapies. Sandy brings a powerful blend of venture capital expertise, entrepreneurial drive, and a deep commitment to the anti-aging and regenerative medicine space. His proven track record in building and scaling companies aligns perfectly with our mission. With his experience and expertise, we see tremendous potential for significant value creation as we advance our clinical pipeline and expand our commercial BioCosmeceuticals platform. I am confident Sandy will play a key role in driving our next phase of growth and innovation," said Lance Alstodt, Chief Executive Officer of BioRestorative. Mr. Lipkins stated, 'I am excited to join BRTX at such a pivotal time. The Company's dedication to cutting-edge science in both clinical development and consumer wellness is inspiring, and I see tremendous opportunity to build something truly impactful here. With a strong foundation already in place, I look forward to helping accelerate growth, expand the biocosmeceuticals platform, and bring transformative regenerative solutions to market — both at home in the U.S. and abroad in key international markets.' About BioRestorative Therapies, Inc. BioRestorative ( 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 also operate a commercial BioCosmeceutical platform: • 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. We have also obtained U.S. Food and Drug Administration ('FDA') Investigational New Drug ('IND') clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain. • 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 IND-enabling studies, with the aim of pioneering 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 KilmerInvestor RelationsDirect: (646) 274-3580Email: skilmer@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
15-05-2025
- Business
- Yahoo
BioRestorative Therapies Inc (BRTX) Q1 2025 Earnings Call Highlights: Navigating Challenges ...
Revenue: $25,000 for Q1 2025, compared to $35,000 in Q1 2024. Deferred Revenue: $150,000 in Q1 2025, compared to nil in Q1 2024. Loss from Operations: $4.8 million in Q1 2025, compared to $4.1 million in Q1 2024. Net Loss: $5.3 million, or $0.64 per share, in Q1 2025, compared to $2.2 million, or $0.33 per share, in Q1 2024. Cash Used in Operating Activities: $2.8 million in Q1 2025. Cash, Cash Equivalents, and Marketable Securities: $9.1 million as of March 31, 2025. Outstanding Debt: None as of the end of Q1 2025. Warning! GuruFocus has detected 4 Warning Signs with BRTX. Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioRestorative Therapies Inc (NASDAQ:BRTX) achieved FDA fast track designation for their BRTX-100 program, facilitating development and review processes. The company reported no serious adverse events in their ongoing Phase II study for BRTX-100, indicating a positive safety profile. Preliminary data from the BRTX-100 trial shows promising trends in pain reduction and functional improvement. BioRestorative Therapies Inc (NASDAQ:BRTX) ended the quarter with a strong financial position, holding $9.1 million in cash, cash equivalents, and marketable securities with no outstanding debt. The company has expanded its intellectual property portfolio, enhancing protection for its ThermoStem program targeting obesity and metabolic disorders. BioRestorative Therapies Inc (NASDAQ:BRTX) reported a decrease in quarterly revenues from $35,000 in Q1 2024 to $25,000 in Q1 2025. The company's net loss increased significantly to $5.3 million in Q1 2025 from $2.2 million in Q1 2024. Enrollment challenges persist due to strict criteria for the BRTX-100 trial, although new recruitment strategies are being implemented. There is uncertainty regarding the potential interim analysis of the BRTX-100 trial, which could impact the trial's progression. The company is still in discussions for a potential license agreement for its ThermoStem program, with no assurance of reaching a mutually acceptable agreement. Q: You mentioned a preliminary endpoint of greater than or equal to 30% improvement. Is there a possibility that this endpoint will change to greater than or equal to 50%? A: Francisco Silva, Vice President of Research & Development, clarified that the endpoint remains at a 30% improvement. The term "preliminary" refers to the fact that the primary endpoint is safety, not efficacy, as this is a first-in-man study. Q: Will there be an interim analysis at 26 weeks, as previously mentioned? A: Francisco Silva stated that an interim analysis is still a potential option but has not been determined. The company is considering the impact of unblinding data on the trial's long-term development and is in discussions with the FDA about leveraging data for regulatory processes. Q: Where are the 45 subjects for the upcoming presentation in Hong Kong coming from? A: Francisco Silva explained that these subjects are from the current study, having been dosed at different time points. The presentation is scheduled for June. Q: Do you expect enrollment to slow down during the summer? A: Lance Alstodt, CEO, noted that enrollment is actually picking up due to new recruitment strategies. Historically, there has been a slowdown in summer, but the company is optimistic about maintaining the current pace. Q: Has the FDA emphasized more on pain or function in their feedback? A: Lance Alstodt mentioned that discussions with the FDA are ongoing, and while pain is a meaningful endpoint, there is flexibility in discussing function as an endpoint. Q: Can you provide more details on the morphological changes observed in response to the cells? A: Francisco Silva described encouraging morphological changes, such as increased hydration and decreased protrusion size in some subjects, indicating aggressive remodeling within the disc. Q: Could mature morphological data potentially reduce the size of a registration study? A: Francisco Silva believes that the positive environment for cell-based therapies and the safety profile of BRTX-100 could allow the company to leverage this data in discussions with the FDA to potentially reduce the size of future studies. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
