BioRestorative Therapies, Inc. reported a net loss of $8.98 million for the fiscal year ending December 31, 2024, a decrease from a loss of $10.42 million in the previous year. The company generated $401,000 in revenue, a significant increase from $145,800 in 2023, primarily attributed to its cosmeceuticals business and sublicense agreements. Operating expenses decreased to $11.93 million from $15.37 million, driven by a reduction in general and administrative costs, particularly stock-based compensation. The company’s accumulated deficit now stands at $155.68 million, raising concerns about its ability to continue as a going concern without additional financing.

In terms of strategic developments, BioRestorative is advancing its Disc/Spine Program, with its lead product candidate, BRTX-100, currently undergoing a Phase 2 clinical trial authorized by the FDA for treating chronic lower back pain due to degenerative disc disease. The company has also made progress in its ThermoStem Program, which focuses on using brown adipose-derived stem cells for treating metabolic disorders. Notably, in April 2024, the FDA approved a protocol amendment for the BRTX-100 trial, enhancing the study's design by replacing saline injections with sham injections in the control group.

Operationally, BioRestorative has expanded its laboratory capabilities to support clinical production and has entered into a five-year exclusive supply agreement with Cartessa Aesthetics for its proprietary cell-based biologic serum. The company has also received several patents related to its programs, including recent approvals in Japan and Europe for its ThermoStem technology. As of March 2025, BioRestorative had 11 full-time employees and is actively seeking to increase its workforce to support its growth initiatives.

Despite these advancements, the company faces significant challenges, including the need for substantial additional funding to complete its clinical trials and operational plans. As of December 31, 2024, BioRestorative had working capital of $7.4 million, which it anticipates will not be sufficient to cover its operational needs for the next twelve months. The company has initiated various financing strategies, including an At The Market Offering Agreement with Rodman & Renshaw, which allows it to raise up to $3.6 million through the sale of common stock.

Looking ahead, BioRestorative acknowledges the inherent risks associated with its business model, particularly in the highly regulated field of regenerative medicine. The company is focused on securing the necessary funding and regulatory approvals to advance its product candidates while navigating the competitive landscape of stem cell therapies. The successful commercialization of its products remains contingent on overcoming these challenges and achieving favorable clinical trial outcomes.

About BioRestorative Therapies, Inc.

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