Biorestorative Therapies Q2 2025 Earnings Report

Biorestorative Therapies EPS Results

• Actual EPS: -$0.30
• Consensus EPS: -$0.41
• Beat/Miss: Beat by +$0.11
• One Year Ago EPS: N/A

Biorestorative Therapies Revenue Results

• Actual Revenue: $0.30 million
• Expected Revenue: $0.34 million
• Beat/Miss: Missed by -$37.00 thousand
• YoY Revenue Growth: N/A

Biorestorative Therapies Announcement Details

• Quarter: Q2 2025
• Date: 8/12/2025
• Time: After Market Closes
• Conference Call Date: Tuesday, August 12, 2025
• Conference Call Time: 4:30PM ET

Biorestorative Therapies (NASDAQ:BRTX), a life sciences company, focuses on the development of regenerative medicine products and therapies using cell and tissue protocols primarily involving adult stem cells. The company's two core developmental programs relate to the treatment of disc/spine disease and metabolic disorders. Its disc/spine program (brtxDisc) includes a lead cell therapy candidate, BRTX-100, a product candidate formulated from autologous cultured mesenchymal stem cells collected from the patient's bone marrow, which has completed Phase 1 clinical trials for use in the non-surgical treatment of painful lumbosacral disc disorders. The company is also developing Metabolic Program (ThermoStem), a cell-based therapy candidate that is in preclinical stage to target obesity and metabolic disorders using brown adipose derived stem cells to generate brown adipose tissue. In addition, it provides investigational curved needle device designed to deliver cells and/or other therapeutic products or material to the spine and discs. BioRestorative Therapies, Inc. has a research and development agreement with Rohto Pharmaceutical Co., Ltd.; a research agreement with Pfizer, Inc.; and a research collaboration agreement with the University of Pennsylvania. The company was formerly known as Stem Cell Assurance, Inc. and changed its name to BioRestorative Therapies, Inc. in August 2011. The company was incorporated in 1997 and is based in Melville, New York.

Biorestorative Therapies Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: BioRestorative reported Q2 revenues of $303K, up 240% year-over-year, driven primarily by its biopharmaceutical contract manufacturing agreement.
• Positive Sentiment: Blinded data from the Phase II trial of BRTX-100 in chronic lumbar disc disease showed over 74% of subjects achieved >50% functional improvement and over 72% had >50% pain reduction at 52 weeks.
• Positive Sentiment: The company is now over halfway enrolled in its 99-subject Phase II trial and plans a Type B meeting with the FDA to discuss an accelerated Biologics License Application pathway for BRTX-100.
• Positive Sentiment: Substantive licensing discussions are underway for the ThermoStem metabolic disease program, supported by a growing global patent portfolio covering brown adipose tissue therapies.
• Positive Sentiment: BioRestorative finished Q2 with $7.4M in cash, cash equivalents and marketable securities and no debt, underscoring a strong financial position to fund further development.

Presentation

[Operator]

Greetings. Welcome to the BioRestorative Therapies Second Quarter twenty twenty five results and business update conference call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press Please note this conference is being recorded.

[Operator]

I will now turn the conference over to your host, Stephen Kilmer, Investor Relations. You may begin.

[Stephen Kilmer, Investor Relations at BioRestorative Therapies]

Thank you, Ollie. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All forward looking statements are based on BioRestorative Therapy's current beliefs, assumptions and expectations. And such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.

[Stephen Kilmer, Investor Relations at BioRestorative Therapies]

No forward looking statement can be guaranteed. For details on factors, among others, that could affect our expectations, see Part one, Item 1A of our annual report on Form 10 ks for the year ended 12/31/2024, filed with the Securities and Exchange Commission. Listeners are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call. BioWare Storenof undertakes no obligation to publicly update or revise any forward looking statement, whether as a result of new information, future events or otherwise other than as required by law. On the call today representing the company are Lance Altschot, BioResverative's Chairman and Chief Executive Officer Francisco Silva, Vice President of Research and Development and Robert Crystal, the company's Chief Financial Officer.

[Stephen Kilmer, Investor Relations at BioRestorative Therapies]

With that said, I'll now turn the call over to Lance.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

Thanks, Steve. Good afternoon, everyone and welcome. On behalf of the management team and everyone at Bio Restorative. I'd like to thank you for your interest in the company. And for those of you who are shareholders, we appreciate your support.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

As you can see from the press release, we executed very well across all areas of the business in the second quarter, a continuation really from Q1, and we have a lot of exciting things to look forward to as we move through the second half of the year. With that said, I'd like to ask Rob Crystal, our CFO, to provide a brief overview of our second quarter financial results.

[Robert Kristal, CFO at BioRestorative Therapies]

Thanks, Lance. Good afternoon, everyone. To streamline the presentation of the financial results, all the numbers I will refer to have been rounded, they are approximate. Second quarter twenty twenty five revenues were $303,000 compared to $89,000 in the same period last year. This represents an increase of 240%, primarily resulting from our contract manufacturing agreement on BioCosarmaceuticals.

[Robert Kristal, CFO at BioRestorative Therapies]

The company's second quarter twenty twenty five loss from operations was 3,300,000.0, compared to 2,500,000.0 for the comparable period of 2024. The company's second quarter twenty twenty five net loss was 2,700,000.0 or $0.30 per share, compared to a net loss of 4,000,000 or $0.50 per share for the 2024. The company ended the quarter in a strong financial position with cash, cash equivalents and marketable securities of 7,400,000.0 and no outstanding debt. With that, I'll now turn the call over to Francisco.

[Francisco Silva, Chief Scientist, VP of Research & Development and Director at BioRestorative Therapies]

Thanks, Rob. For the benefit of those who are new to the BioRestorative story, I would like to take a moment to summarize our developmental programs. Our lead clinical stage candidate BRTX-one hundred is a novel cell based therapeutic engineered to target areas of the body that has little blood flow. The product is formulated from autologous or a person's own cultured mesenchymal stem cells collected from the patient's bone marrow. The safety and efficacy of BRTX-one hundred in treating chronic lumbar disc disease or CLDD is being evaluated in an ongoing phase two prospective randomized double blinded and controlled study.

[Francisco Silva, Chief Scientist, VP of Research & Development and Director at BioRestorative Therapies]

A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites across The United States. Subjects included in trial will be randomized two to one to receive either BRTX100 or placebo. In a recent presentation that I gave a few weeks ago as part of the clinical innovations track at the International Society for Stem Cell Research or ISSCR twenty twenty five annual meeting in Hong Kong, I reviewed very promising blinded data from the first 36 subjects enrolled in the phase two trial. By the way, that number of subjects was up more than twofold since my previous presentation at ISCT back just in May. To help put the preliminary data results in perspective, the FDA is requiring at least a greater than 30% improvement in function in the Oswestry Disability Index or ODI, and a greater than 30% reduction in pain on the Visual Analog Scale or VOZ in determining whether the clinical trial will be allowed to proceed and ultimately gain BLA approval.

[Francisco Silva, Chief Scientist, VP of Research & Development and Director at BioRestorative Therapies]

Thus far, BRTX-one hundred is doing much better than that. As I presented ISSCR, over seventy four percent of the subjects showed greater than 50% improvement in function by fifty two weeks. Over seventy two percent of the subjects reported greater than 50% reduction in pain by fifty two weeks. And combined greater than 50% improvement in both ODI and VAS measures was achieved by a meaningful portion of subjects across all time points. From a safety perspective, again, no serious adverse events or dose limiting toxicities were reported between twenty six and one hundred and four weeks at the target dose of forty million cells.

[Francisco Silva, Chief Scientist, VP of Research & Development and Director at BioRestorative Therapies]

The data presented at ISSCR was meaningful and demonstrated a strong signal for safety and efficacy, and has helped us in connection with an increased enrollment rate. In fact, I am pleased to report that we are now more than halfway through enrollment of our 99 subject enrollment goal. In addition, again, based on the positive preliminary data, we intend to meet with the FDA in connection with proposed Type B meeting in order to accelerate the regulatory pathway towards a BLA license of our BRTX-one hundred candidate. This is really exciting news and we hope to be in a position to discuss further in the coming weeks. Moving to our core preclinical metabolic program, THERMACEM, we are developing cell based therapy candidates to target obesity and metabolic disorders using brown fat or fat derived stem cells to generate brown adipose tissue or BAT, as well as exosomes secreted by the BATS cells.

[Francisco Silva, Chief Scientist, VP of Research & Development and Director at BioRestorative Therapies]

BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans and is involved in weight loss. While further work is needed to fully understand the mechanism of action of Thermostat and its impact on weight loss, we have not seen nor do we expect the same negative secondary effects of GLP-one pharmaceuticals, such as loss of muscle mass and negative cardiovascular effects. As awareness of the promise that our thermostat based bat holds for the treatment of obesity and related metabolic disorders continues to grow, it is important that this potentially game changing opportunity is well protected both for us and any current and our future potential licensing partners. Accordingly, we have been methodically building a comprehensive portfolio of issued patents that cover The US and international markets. And we are pleased to see our previously reported substantive discussions with an undisclosed commercial state regenerative medicine company with regard to a potential license agreement for our Thermostat Metabolic Disease programs are continuing.

[Francisco Silva, Chief Scientist, VP of Research & Development and Director at BioRestorative Therapies]

While we cannot provide interim progress updates nor provide any assurances that we will come to a mutually acceptable agreement, we are committed to closing the loop on this as soon as practical. With that, I will turn the call over back to Lance.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

Thanks, Francisco. As you can see from what Francisco and Rob just reviewed, we've had an exciting and productive second quarter. And while that progress continues, we're carefully managing our resources as we advance our two core clinical development programs, BRTX100 and ThermoStem, while ramping our commercial opportunities on regenerative biologic secretone products. With respect to the latter, we're in advanced discussions with key partners and influencers to help accelerate the growth of this program and look forward to reporting more catalysts and news from it going forward. So to summarize, we're making great progress with our phase two trial for BRTX-one hundred to treat CLDD.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

And while the data is still blinded, the initial trends continue to be very encouraging. We have great safety profile, and also highlighted by a greater than fifty percent improvement in pain and function in a significant portion of CLDD subjects. We intend to present more data from this trial with a larger patient population, and we are very optimistic that this data will be consistent with the previous trends. In addition, and as highlighted by Francisco, we are very about our regulatory pathway now that we have gotten very close to about three quarters of the trial enrolled. So we look forward to having that upcoming meeting with the FDA.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

We continue to be in substantive discussions with regard to a potential license of the ThermoStand Metabolic IP. And we're also in substantive discussions with partners on the commercial biocosmaceutical platform to help expand our contract manufacturing business opportunities. And finally, we ended the second quarter in a very strong financial position with cash, cash equivalents and marketable securities of 7,400,000.0 as of 06/30/2025. We will continue to efficiently manage our cash reserves while executing upon our strategic goals. With that, I thank you all, given some of our introductory comments, and we're happy to take any questions you may have.

[Operator]

Certainly. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Thank you very much, guys. Could you say anything about the timing for the start of the CCDT trial and the size of that trial?

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

No, we did not comment on the cervical trial. Our goal is we could effectively pursue a variety of different indications as everyone knows. Our cervical trial has been approved to initiate a phase two, and we probably could get the same sort of status on a variety of other avascular zones being hips, knees and shoulders. And I think what we really want to focus and laser focus in on is our lumbar trial and getting that into a BLA. So we're really encouraged by the tremendous growth that we've seen enrollment over the quarter, very proud of the team and our service providers in assisting us in that process.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

And our goal right now is to drive that into a phase three, and hopefully we'll have some really good insight in terms of how the FDA is thinking about it, given how much we've enrolled recently.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Okay, on the revenue side with Cosmoceutical driving it, do you think that versus the last couple of quarters that this is pretty much up and up from here or is it too lumpy to say that?

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

I think it's a little early. Up and up is difficult comment to react to because it's somewhat of a growing business. I think what we'll see is a tremendous increase in visibility. As you know, we've hired Sandy Lipkins, who is an innovator and a pioneer within the space. And he's been doing a lot of the groundwork, making sure that some of the meaningful consumers of these products are aware of us.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

And from a back office perspective, we've been making sure that we're appropriately documented and qualified and validated in order to commercialize these programs at a rate that would be consistent with some of our expectations. So we think it's up and up from the standpoint of starting at certain base, but I don't have a whole lot of guidance for you in terms of what we should expect quarterly going forward.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Okay, lastly, we exist probably more for Rob, should we expect the same SG and A expense trend this year, like last year heavy in the first quarter similar but lighter, much lighter quarters two through four?

[Robert Kristal, CFO at BioRestorative Therapies]

Yes, that would be appropriate.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Excellent, that's all I have for you guys. Thank you.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

And I would also, I would just add to that, just to give you a little bit more insight, Jonathan is, as we turn the corner and get into 2026 and if our enrollment continues to tick at the pace at which it is, and we have some of these very positive developments with the FDA in terms of our regulatory pathway, we could expect sort of a cool down in SG and A as it relates to not having to enroll the amount of patients in the 2026 as we sort of gear up for a phase three.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Okay. Lastly, the COGS looked really kind of low for three zero three ks in our revenues. That's what's gonna kind of look like going forward? I kind of a lot higher COGS in that.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

Yeah, think our margin related to some of the secret home products are without giving specific numbers. I think, this is not by coincidence that this is a business that we want to be in. Not only is it a huge market, and we don't need much of a penetration rate to put up some pretty big revenue numbers, but it's at quite a high margin as well.

[Robert Kristal, CFO at BioRestorative Therapies]

And Jonathan, would just add to the COGS specifically that we improved some, We improved our efficiencies a little bit in terms of making product. And then the packaging costs as well. We improved some pricing there by shopping really some different vendors for particular things we need in the packaging.

[Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC]

Thanks a lot, Rob.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

Thanks, Jonathan. Appreciate it.

[Operator]

Your next question is from Michael Okunowicz with Maxim.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Hey, Michael. Hey, guys. Thank you so much for taking my questions today. Congrats on all the great progress.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

Yeah. Thanks.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

So so I guess just to kick things off, we have seen some vocal support from FDA leadership for stem cells. You have a controlled study in phase two. You previously mentioned the desire to bring this as a registrational and now that type B meeting is planned. So have there been any new recent interactions with FDA suggesting there may be further support for that expedited pathway?

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

I can tell you anecdotally what we've heard, which would imply that there is a lot of wind at our backs with respect to an accelerated pathway. However, we have not learned directly through our conversations with the FDA that we have been designated other than just our fast track designation, anything more than what we've disclosed.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

All right, thank you. And then with regards to phase two, the threshold with FDA is 30% on pain and function, but that's from baseline. Correct? So what would you need to show versus placebo? Is that a comparison based on the proportion of responders magnitude? Just give a bit more color on that.

[Francisco Silva, Chief Scientist, VP of Research & Development and Director at BioRestorative Therapies]

Yeah, so that's, it's based on 30% minimum of at least 30% in both pain and function as compared to baseline. And then that cohort is compared to the control group that is not undergoing any type of intradiscal injection, it's a sham. And then comparing both cohorts and looking at a responder rate.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

And Michael, I would also add just in case there's any ambiguity, our primary endpoint is safety. And we've not had as Francisco mentioned, we've not had any material adverse events or dose limiting toxicity. So, to use our CRO's words, not our own. This is probably the best safety profile that they've ever seen. So the FDA doesn't even look at some of the secondary efficacy endpoints, unless you have a pretty clean bill of health from a safety perspective.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

So we feel like based on the data that we've talked about, and that we've analyzed, at least on a blinded basis, not only is this product extremely safe, but we are seeing tremendous signal from an effect from an effectiveness perspective.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Yeah. No, what we've seen so far is certainly encouraging. I'd like to actually just follow-up on that. And you give a sense of when we could start to see some unwanted data? Is there potential for an unblotted interim? Are we gonna have to wait for the full 99?

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Or is this something that we better asked on the back end of that type B meeting?

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

I think it's better asked on the back half because it will really help shape what the regulatory strategy will be. We may be in a position to, through blinded data, get to the next stage, and maybe even get to the next stage prematurely, which would be phenomenal news and would be a huge cost savings and put us in a position of really driving the phase three. And if that is the decision, and if that is the nature of the conversation, and remember, the tides have turned, at least from the administration's perspective on cell based therapies. So we feel like this winded our back to drive to that potential outcome. And if so, we wouldn't want to give up the alpha associated with an interim analysis.

[Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group]

Yeah, no, it makes a lot of sense. And it's certainly an encouraging time Gonna be looking forward to hearing the results of that.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

Yeah, I'll tell you for as long as we've been here, we've never been so encouraged about where we are as it relates to the enrollment results, the regulatory environment, and some of these upcoming conversations, as well as all cylinders kind of hitting on bio cosmeceutical. So I think you're gonna see a big change in our profile and what the opportunity set looks like going forward into the back half of the year.

[Operator]

We have reached the end of the question and answer session, and I will now turn the call over to Lance Allstadt for closing remarks.

[Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies]

Yes. Again, I appreciate everyone's attention to the company following us diligently. Great questions as usual from the analyst community. Thank you again to our investors for your continued interest and support. We look forward to talking to you all soon. Thank you.

[Operator]

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

Participants

Analysts

• Stephen Kilmer, Investor Relations at BioRestorative Therapies
• Lance Alstodt, Chairman of the Board, President & CEO at BioRestorative Therapies
• Robert Kristal, CFO at BioRestorative Therapies
• Francisco Silva, Chief Scientist, VP of Research & Development and Director at BioRestorative Therapies
• Jonathan Aschoff, MD & Senior Research Analyst at Roth Capital Partners, LLC
• Michael Okunewitch, Senior Research Analyst - Biotechnology at Maxim Group