BRTX News & Events

BioRestorative Therapies issued the following letter to shareholders from Chief Executive Officer Lance Alstodt: "The first quarter of 2026 marks a pivotal period for BioRestorative Therapies. We have achieved significant milestones and have strong momentum across our clinical programs, regulatory pathways, commercial initiatives, and capital strategy. We believe the Company is well-positioned at a meaningful value inflection point, supported by: Completion of enrollment in our fully powered Phase 2 trial of BRTX-100; Positive Type B regulatory outcome and alignment on the BLA pathway; Initiation of Phase 3 enabling activities; Strengthened capital position following a $5 million public offering; Acceleration of our commercial BioCosmeceutical strategy; Continued development of our ThermoStem metabolic platform... Following our recent $5 million public offering, we have strengthened our balance sheet and extended our operational runway. We are focused on maintaining optionality, advancing BRTX-100 through key data readouts, and preserving leverage ahead of potential partnership discussions... Our primary focus in 2026 is advancing BRTX-100 into late-stage development with regulatory clarity and operational readiness for BLA approval. This includes the initiation of Phase 3 enabling activities, the refinement of protocol elements consistent with prior FDA feedback, the confirmation of manufacturing readiness, and the submission of the Phase 3 IND amendment, targeted for the second half of 2026... We intend to report Phase 2 topline results in early 2027 in accordance with the pre-specified statistical analysis plan... Outside the United States, commercial applications of cell-based biologics, such as stem cells, have advanced significantly over the past several years and have continued to grow in 2026... Our BioCosmeceutical platform will continue to be developed with a focus on operational execution and margin discipline... We believe BioRestorative is transitioning from development-stage uncertainty toward late-stage regulatory clarity. Our focus remains on execution, data integrity, capital efficiency, and long-term shareholder value."

BioRestorative Therapies announced that IP Australia, the intellectual property branch of the Australian government, has allowed Patent Application No. 2020265664 titled, "Non-naturally occurring three-dimensional brown adipose-derived stem cell aggregates, and methods of generating and using the same." The newly allowed patent application provides the broadest protection obtained for BioRestorative's allogeneic, off-the-shelf, brown adipose-derived stem cell ThermoStem technology, designed to treat obesity and metabolic disorders. The claims covered are: a method of making a non-naturally occurring three-dimensional brown adipose derived stem cell aggregate.

Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering. The gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for its clinical trials with respect to BRTX-100, pre-clinical research and development with respect to its ThermoStem Program, the development of its commercial biocosmeceuticals platform and for general corporate purposes and working capital.

BioRestorative Therapies, provided an update following the feedback received from the FDA regarding a potential expedited Biologics License Application approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease, based on a Type B meeting requested by the Company. "The positive outcome of our Type B meeting with the FDA provides the clarity needed to support a pathway to expedited BLA approval for our BRTX-100 program in cLDD," said Lance Alstodt, CEO. "In addition, we believe the fact that we can prepare and submit the Phase 3 IND application ahead of unblinding the ongoing Phase 2 trial is a testament to the excellent safety profile and upward trend in efficacy endpoints demonstrated to-date." Based on ongoing activities, the Company currently anticipates that the Phase 3 trial IND submission will be made in the second half of 2026.