BioRestorative outlines BioCosmeceuticals expansion with new leadership and eyes $63B market opportunity

Earnings Call Insights: BioRestorative Therapies, Inc. (BRTX) Q3 2025

MANAGEMENT VIEW

* Lance Alstodt, Chairman of the Board, President & CEO, emphasized, "we continue to execute well across all areas of our business in the third quarter. We have a lot of exciting things to look forward to as we move through the last couple of months of the year."
* Robert Kristal, Chief Financial Officer, stated, "Third quarter 2025 revenues were $11,800 and consisted entirely of royalty revenue. This compares to revenues of $233,600 in Q3 2024, the vast majority of which came from BioCosmeceutical sales in connection with our exclusive supply agreement with Cartessa. The company's third quarter 2025 loss from operator was $3.7 million, compared to $2.3 million for the comparable period of 2024. The company's third quarter 2025 net loss was $3 million or $0.33 a share, compared to a net loss of $1 million or $0.13 per share for the third quarter of 2024. The company ended the quarter with cash, cash equivalents and marketable securities of $4.5 million with no outstanding debt. This did not include the gross proceeds of approximately $1.1 million from the company's recent financing, which we completed subsequent to the quarter end."
* Francisco Silva, VP of Research & Development, highlighted the continued progress of the BRTX-100 Phase II clinical trial, noting a Fast Track designation by the FDA and anticipated discussions regarding an accelerated BLA approval pathway. Silva also announced ongoing discussions for a potential license agreement for the ThermoStem metabolic disease program and a new Japanese patent allowance strengthening the company's intellectual property portfolio.
* Alstodt announced, "Over the last several months, we've rebuilt and strengthened our commercial infrastructure... A major part of that strategy was bringing in the right commercial leader... we welcomed Crystal Romano as our Global Head of commercial operations." He described the BioCosmeceuticals opportunity as a $63 billion market and expressed confidence in the new leadership to drive "scalable revenue growth."
* Alstodt also noted, "We believe that enrollment in our Phase II BRTX-100 clinical trial is approaching completion... the initial trends continue to mirror our earlier clinical signals, including significant improvement in pain and function for patients suffering from chronic lumbar disc disease."
* Alstodt highlighted a recent financing round, stating it was "fully subscribed... priced above market. Senior leadership, including myself and several of our existing investors participated in the round."

OUTLOOK

* Management expects continued progress in enrolling the BRTX-100 Phase II trial, with the study nearing full enrollment. Alstodt indicated, "Each month, we move closer to a fully enrolled study and a more statistically powerful data set." The company anticipates a potential Type B FDA meeting in December to discuss the regulatory pathway for BRTX-100.
* Alstodt described BioCosmeceuticals as a "business capable of generating revenue alongside our clinical programs" and suggested it "can become a very material contributor in 2026 and beyond."
* Ongoing discussions continue regarding a potential license for the ThermoStem program, but no interim updates or assurances were provided.

FINANCIAL RESULTS

* Revenues for Q3 2025 were $11,800, exclusively from royalty revenue, compared to $233,600 in Q3 2024, which was primarily from BioCosmeceutical sales. The decrease was attributed to the timing of orders in the BioCosmeceutical revenue stream.
* The net loss for Q3 2025 was $3 million or $0.33 per share, compared to $1 million or $0.13 per share in Q3 2024.
* The company ended Q3 with $4.5 million in cash, cash equivalents, and marketable securities and reported no outstanding debt. A subsequent financing round brought in approximately $1.1 million in gross proceeds.

Q&A

* Michael Okunewitch, Maxim Group, asked about the significance and strategy for the BioCosmeceuticals business and whether additional Cartessa-like deals would be needed. Alstodt responded, "It is going to be a segmental focus for us going forward and really positioning the company as a hybrid... This is a $63 billion market opportunity... We are approaching this market originally with an exclusive distribution agreement with Cartessa... we're going to add additional distributors... We will also be selling directly into the med spas and aestheticians, the professional channel... I would also like to discuss potentially the idea of going direct-to-consumer with a branded product that we've been discussing."
* Okunewitch asked about resource allocation between clinical and commercial efforts. Alstodt indicated the company could manage both with its current team, potentially adding quality and manufacturing staff, and expects to capitalize on full lab utilization during lulls in clinical activity.
* Jonathan Aschoff, ROTH Capital Partners, asked about timing for BRTX-100 data releases and enrollment. Alstodt shared, "we're more than 3 quarters enrolled, and we have another more than 10 patients in late-stage screening... we're getting really close... As far as data, we're going to keep the data blinded because we have a strategy as it relates to communication with the FDA under our Fast Track designation, looking to accelerate the BLA process."
* Aschoff inquired about the cervical trial. Alstodt replied, "We haven't dedicated resources to developing it... I think this is something that we want to mark, that we have experienced, getting multiple INDs approved."
* Aschoff asked if BioCosmeceutical revenues would recur in Q4. Alstodt answered, "I know that some products have been sold since Crystal has been on board. But it's probably nascent relative to what I think the opportunity looks like as we begin to scale."

SENTIMENT ANALYSIS

* Analysts focused on clarity around BioCosmeceuticals strategy, near-term revenue visibility, and clinical progress, with a neutral to slightly positive tone, and signaled interest in commercialization and regulatory pathways.
* Management maintained a confident tone in prepared remarks, stressing "tremendous confidence" in new commercial leadership and optimism about clinical milestones, while during Q&A, Alstodt tempered expectations on immediate revenue impact and regulatory timelines, expressing confidence but also caution: "it's probably nascent relative to what I think the opportunity looks like as we begin to scale."
* Compared to the previous quarter, management’s tone remains optimistic, with a greater emphasis on commercial expansion and leadership changes, while analysts continue to seek revenue predictability and regulatory clarity.

QUARTER-OVER-QUARTER COMPARISON

* The current quarter saw a shift in commercial leadership, with Crystal Romano joining as Global Head of commercial operations, compared to the previous quarter’s focus on contract manufacturing and early commercial groundwork.
* Management provided greater detail on BioCosmeceuticals market strategy, outlining a three-pronged approach and direct-to-consumer opportunities, while clinical updates continued to center on BRTX-100 Phase II trial progress and regulatory milestones.
* Revenue for Q3 2025 was significantly lower than Q2 2025 due to the timing of BioCosmeceutical orders, while net loss increased versus Q3 2024.
* Analysts in both quarters pressed for clarity on commercialization timelines and regulatory strategy, but Q3 saw increased attention to the impact and execution of new leadership.

RISKS AND CONCERNS

* Management acknowledged lumpiness and unpredictability in BioCosmeceuticals revenue, anticipating periods of outsized and lower revenues as the business develops.
* There is uncertainty around the timing and outcome of the FDA Type B meeting, as well as the potential for an accelerated BLA pathway for BRTX-100.
* Ongoing licensing discussions for ThermoStem continue, but management provided no assurances or interim updates.
* The cervical trial remains undeveloped due to resource prioritization, representing a pipeline opportunity but also a deferred risk.

FINAL TAKEAWAY

BioRestorative Therapies highlighted a quarter of strategic transformation, with a renewed commercial push under new leadership targeting the $63 billion BioCosmeceuticals market and continued clinical momentum for BRTX-100 nearing full enrollment. While revenues declined this quarter due to order timing, management underscored confidence in the scalability of its commercial engine and the strength of its balance sheet following a successful financing. Investors can expect continued updates on clinical and commercial milestones as the company positions itself for value creation in 2026 and beyond.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/brtx/earnings/transcripts]

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* BioRestorative Therapies, Inc. (BRTX) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4842760-biorestorative-therapies-inc-brtx-q3-2025-earnings-call-transcript]
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