BRTX

Financial Results - Third-quarter 2025 revenues were $11,800 (royalty revenue) vs. $233,600 in Q3 2024 (mostly biocosmeceutical sales). - Loss from operations in Q3 2025 was $3.7 million vs. $2.3 million in 2024. - Net loss in Q3 2025 was $3 million or $0.33 per share vs. $1 million or $0.13 per share in 2024. ### Development Programs - BRTX-100: Lead clinical-stage candidate for chronic lumbar disc disease in Phase II trial; up to 99 subjects to be enrolled at 16 sites; enrollment approaching completion; initial trends show pain and function improvement. - ThermoStem: Cell-based therapy for obesity and metabolic disorders; ongoing discussions with a commercial-stage regenerative medicine company regarding license; recent Japanese patent allowance for ThermoStem platform. ### Commercial Developments - Biocosmeceuticals: Rebuilt commercial infrastructure; hired Crystal Romano as Global Head of Commercial Operations; plan to add distributors, sell directly to med spas/aestheticians; $63 billion market opportunity in biocosmeceuticals. ### Financing - Completed a fully subscribed financing post-quarter end, strengthening balance sheet and providing resources for clinical and commercial milestones.

Clinical Trial - Enrollment in BRTX-100 Phase II trial approaching completion; more than three-quarters enrolled. - Anticipate potential Type B FDA meeting in December to discuss accelerated BLA approval pathway. ### Commercial - Biocosmeceuticals business expected to contribute meaningfully to revenue in 2026 and beyond. ### Licensing - Ongoing discussions with a commercial-stage regenerative medicine company regarding ThermoStem metabolic program, though no interim updates provided.

Third-quarter 2025 revenues were $11,800, consisting entirely of royalty revenue. This is in contrast to Q3 2024 revenues of $233,600, which were mostly from biocosmeceutical sales under the Cartessa supply agreement. The Q3 2025 loss from operations was $3.7 million, and net loss was $3 million or $0.33 per share, compared to Q3 2024's loss from operations of $2.3 million and net loss of $1 million or $0.13 per share. Cash, cash equivalents, and marketable securities ended the quarter at $4.5 million with no outstanding debt, and a recent financing added $1.1 million in gross proceeds.

Clinical - Uncertainty around timelines for clinical trial enrollment completion and data release. ### Regulatory - Risks associated with FDA approval processes, including potential delays in BLA pathway acceleration. ### Market - Uncertainty in market acceptance of biocosmeceutical products and ThermoStem technology. ### Licensing - Uncertainty in reaching mutually acceptable license agreement for ThermoStem program.

Q: How significant is the biocosmeceuticals opportunity and how will it be tapped?

A: The biocosmeceuticals market is a $63 billion opportunity. Approach includes additional distributors, direct sales to med spas/aestheticians, and potential direct-to-consumer branded products. Crystal Romano's leadership helps leverage account relationships.

Q: When may we see subsequent data release for BRTX-100 and enrollment update?

A: More than three-quarters enrolled, with late-stage screening patients; data will remain blinded for FDA communication strategy related to Fast Track designation.

Q: Do you think biocosmeceutical revenues will recur this year like in the second quarter?

A: It's nascent with Crystal on board, but potential exists as scaling progresses