BioRestorative Therapies, Inc. Q1 FY2025 earnings call

• BRTX-100: Its Phase II prospective, randomized, double blinded and controlled study for chronic lumbar disc disease is ongoing. FDA granted Fast Track designation for BRTX-100 cLDD program and cleared investigational drug application for Phase II clinical trial in chronic cervical discogenic pain. Initial trends from the trial are encouraging with no serious adverse events and positive VAS, ODI data and potential morphological changes.
• ThermoStem: Developing cell-based therapy candidates for obesity and metabolic disorders using brown adipose stem cells. Expanded patent portfolio and continuing discussions with a commercial-stage regenerative medicine company regarding potential license agreement for ThermoStem metabolic disease programs.

For the first quarter of 2025, revenues were $25,000 compared to $35,000 in the same period last year. First quarter 2025 deferred revenues were $150,000 compared to $0 in the first quarter of 2024. The company’s first quarter 2025 loss from operations was $4.8 million compared to $4.1 million for the comparable period 2024. The company’s first quarter 2025 net loss was $5.3 million or $0.64 per share, compared to a net loss of $2.2 million or $0.33 per share for the first quarter of 2024. Cash used in operating activities in the first quarter of 2025 was $2.8 million and the company ended the quarter with cash, cash equivalents and marketable securities of $9.1 million and no outstanding debt.

• Will continue to efficiently manage cash reserves while executing upon strategic goals.
• Expect BRTX-100 Phase II trial data to remain consistent with positive trends and look forward to presenting more data with a larger patient population soon.
• Continue to proactively expand ThermoStem intellectual property estate and progress with discussions on potential license of ThermoStem metabolic IP and other assets.

Q: You called the endpoint, the efficacy endpoint of greater than or equal to 30% improvement, a preliminary end point. I have never really heard of an endpoint called preliminary data, yes, but not an endpoint. And then when you are showing us greater than 50% improvement in this last week’s presentation. So, is that some kind of foreshadowing that the endpoint that you are going to have to hit is no longer going to be greater than or equal to 30% and more like greater than or equal to 50%?

A: No. Good question. But no, we are not changing the endpoint. It’s still both just a 30% improvement...

Q: I noticed in the second slide presentation last week’s versus February, there was no more line about potential interim analysis at 26 weeks. So, that – is that out, or will that still be performed?

A: We haven’t determined that we are going to do an interim, it’s a potential, and that’s still something that’s on the table as an option. We don’t want to compromise the trial in terms of having an interim analysis that could impact the long-term development. Currently, right now, we are having strategy talks with our team internally as well as preparing some FDA communications to see where we could take this trial within the Phase 3 and potentially leverage this data to shorten the regulatory process for BLA approval. So, an interim analysis could impact that since we would have to un-blind. But that’s, again, still something that’s on the table, but we removed it from the presentation.

Q: And the last one is the 45 subject data being presented in HK or China, where are those 45 patients coming from?

A: From the current study, so these are patients that have already been dosed and are at different time points within the visitation in the weeks. So, some of it might be 26, some of it might be 52.

Q: When is that presentation?

A: That’s in June.

Q: Hey guys. Thanks for taking my questions. It looks like you are making significant progress. In terms of speed of enrollment, I understand enrollment is much further along than the 15-patient update that we saw. Do you expect enrollment to continue at its current pace, kind of what is that pace and as we head into summer, do you expect enrollment potentially to slow a little bit with people kind of taking holiday?

A: No. Actually, I think just the reverse actually, we are starting to see a real uptick in patients because of some of the strategies that we have been employed from a recruitment perspective. So, we have kind of opened up a whole host of new strategies that seem to be working better than what has been done in the past. As you know, this is a very difficult and challenging environment in order to find a single disc patient with discogenic pain with given how strict the criteria is. We obviously believe in the criteria in order to have the cleanest and most valid data possible relative to other trials that are out there. So, we are going to continue to stay with the protocol. I think the enrollment is picking up. Historically, we have seen a bit of a slowdown during the summer, but I think we will counteract that with some of the new strategies that we have employed in terms of recruitment.

Q: And in terms of your interactions with FDA, has there been more emphasis from them on pain or function, or do they want to see both, reduction of pain with functional improvement?

A: Well, I will tell you that I think it’s all open for discussion. We haven’t had specific feedback that, for example, function would be dropped from the protocol. I know in some cases, it has been in the past, but we continue to collect data on both of our secondary end points and our primary efficacy end points. We will continue to work with the FDA and discuss a whole host of matters, including what they really want to focus on as we get closer to enrollment. So, I think what we can look forward to is certainly pain will be a very meaningful end point. Function, I think is something that we have a little bit more flexibility in terms of discussing.

Q: And have you provided any additional enrollment or patient characteristics? Are the patients older, younger, middle age, where do you think you are seeing the most response potentially?

A: Well, it’s been ranging. We do have younger patients that are in their early-20s. But then again, we have older patients that are in their late-50s. Blinded data, so we don’t know who or who has not been dosed. And so we got to be careful in terms of how we report the data. But from a very high level, it looks pretty consistent that trends are being formed across the demographics.

Q: Last question, can you just give us a little bit more detail on – you had mentioned morphological changes in response to the cells. Can you discuss a little bit more about what was observed?

A: Yes. So – and again, this is still very early, but it’s very encouraging to see these morphological changes, for example, in one subject. And again, we have – it’s more than just one that’s experiencing this. But in one particular subject that was presented, at baseline, the patient had a protrusion and annular tear as well and at 52 weeks compared to baseline, using the same MRI magnet, we see that there is increased hydration. So, there is an increased T2 signal within the disc, there is a decrease in size of the protrusion. And really interesting is that you see a decrease in the annular tear signal. So, that is showing very aggressive morphological remodeling within the extracellular matrix within the disc and the annulus as well. In another patient compared to baseline at 52 weeks, T2 signal begins to decrease. So, there is less hydration. The protrusion appears to be very notably worse than compared to baseline, and you could see an evolution of extrusion within the disc lesion. So, in that case, the patient got worse as compared to the previous patient that I spoke about, the patient is actually improving.