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MELVILLE, N.Y. - BioRestorative Therapies, Inc. (NASDAQ:BRTX), a clinical-stage biotechnology company with a market capitalization of $13.8 million, specializing in stem cell-based therapies, has announced that it is not materially impacted by the recent U.S. tariffs. The company's lead clinical candidate, BRTX-100, is currently in a Phase 2 trial for the treatment of chronic lumbar disc disease (cLDD).
The U.S. Food and Drug Administration (FDA) has granted the BRTX-100 program Fast Track designation based on positive preliminary safety and efficacy data. Additionally, in February, the FDA cleared an Investigational New Drug (IND) application for BRTX-100 to expand its use for treating chronic cervical discogenic pain (cCDP).
CEO Lance Alstodt emphasized the company's "made-in-America" production strategy, which he credits for their ability to manage costs effectively amidst global supply chain changes. BioRestorative ended 2024 with a robust financial position, boasting over $10 million in cash, cash equivalents, and marketable securities. According to InvestingPro data, the company maintains impressive gross profit margins of 93% and holds more cash than debt on its balance sheet, though analysts note the company is quickly burning through its cash reserves. The company plans to continue managing its cash reserves while pursuing its strategic goals.
BioRestorative's core clinical programs focus on disc/spine disease and metabolic disorders. Their disc/spine program, brtxDISC™, involves a non-surgical treatment for painful lumbosacral disc disorders using BRTX-100, a product derived from a patient's own cultured mesenchymal stem cells. The metabolic program, ThermoStem®, is developing therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells.
The company also operates a commercial BioCosmeceutical platform, producing a cell-based serum designed to reduce the appearance of fine lines and wrinkles. They are exploring the potential to expand this offering to include a broader range of cell-based aesthetic products.
This information is based on a press release statement from BioRestorative Therapies, Inc. As a clinical stage company, BioRestorative continues to advance its research and development efforts, with the aim of addressing chronic pain and metabolic conditions through innovative regenerative medicine.
In other recent news, BioRestorative Therapies Inc. reported its fourth-quarter 2024 earnings, showing mixed results. The company achieved a revenue of $500,000, surpassing the forecast of $475,000, marking a 175% increase year-over-year. However, the earnings per share (EPS) was -$0.375, missing the forecasted -$0.275, reflecting ongoing financial challenges. Despite the revenue growth, the company experienced a net loss reduced to $9 million, down from $10.4 million in 2023. BioRestorative's BRTX100 Phase II trial demonstrated promising preliminary results, earning the FDA's Fast Track designation, which could expedite its review process. The company also received clearance for a Phase II clinical trial targeting chronic cervical discogenic pain. Analysts from firms like Maxim Group have shown interest in the company's strategic expansion into other musculoskeletal indications. The company's cash reserves ended 2024 at $10.7 million, with no outstanding debt, indicating a stable financial position amidst ongoing clinical developments.
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