Q4 2024 BioRestorative Therapies Inc Earnings Call
Speaker Change: Good afternoon everyone and welcome to the BioRestorative Therapies 2024 Results Conference Call.
Speaker Change: At this time, all participants are in a listen-only mode, and if anyone should require operator assistance during this conference, please press star zero on your phone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer, investor relations, sir the floor issues.
Stephen Kilmer: Thank you, Jenny. Good afternoon, everyone. Let me start by pointing out that this conference call will include four of the constatements within the meaning of the Private Security's litigation reform act of 1995.
Stephen Kilmer: All form-looking statements are based on BioRestorative Therapy's current beliefs, assumptions and expectations, and such statements involve known and unknown risks in certain of these and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.
No form of infestation can be guaranteed.
Stephen Kilmer: For details on factors among others that could affect expectations, C-PART-1, Item-1-8 of our Annual Report on Form 10K for the year end of December 31st, 2024, which will be followed with the securities and exchange question.
Stephen Kilmer: Listeners are cautioned not to place undue reliance on these four-elected statements, which speak only of the days of this conference call. BioRestorative undertakes no obligation to publicly update or revise any four-elected statement.
Stephen Kilmer: Whether as a result of new information, teacher events are analyzed, other events are fired by law.
Speaker Change: on the call representing the company, Earl Lance Alstodt, BioRestorative's chairman and chief executive officer, Francisco Silva, its vice president of research and development, and Rob Crystal, the company's chief financial officer.
Lance Alstodt: Well, that said, I'm now from the column over to Lance.
Lance Alstodt: And everyone at bio restorative I'd like to thank you for your interest in our company and for those of you who are shareholders. We of course appreciate your support.
As you can see from the press release, we issued a short time ago, we continue to execute well across all areas of our business in 2024, and we have a lot of exciting things to look forward to as we move through 2025 with that said I'd like to ask Robb, our chief financial officer to provide a brief one.
Robb: A review of our 2024 financial results.
Robb: Thanks, Lance good afternoon, everyone to streamline the presentation of the financial results all the numbers I will refer to have been rounded. So they are approximate for the 12 month period ending December 31, 2024 borrowers started as revenue grew 175% year over year to 401000.
Robb: The company's loss from operations was $11 6, million% to 24% improvement from the 15 2 million loss for 2023 the.
Robb: The company's 2024, net loss was $9 million or $1 16 per share a 14% improvement from a net loss of $10 4 million or $2 47 per share for 2023.
Robb: Cash used in operating activities in 2024 was $8 $2 million and the company ended the year in a strong financial position with cash cash equivalents and marketable securities of $10 $7 million and no outstanding debt.
Francisco Silva: With that I'll turn the call over to Francisco.
Francisco Silva: Thanks, Rob for the benefit of those that are needed by restarted story I would like to take a moment to summarize our developmental programs.
Francisco Silva: Our lead clinical stage candidate <unk> 100 is a novel cell based therapeutic engineered to target areas of the body that little blood flow.
Francisco Silva: Product is formulated from autologous or your own call chicken as income will stem cells collected from the patients bone marrow.
Francisco Silva: The safety and efficacy of beer T X 100, intriguing chronic lumbar disc disease or C. L. D. D is being evaluated in our ongoing phase two prospective randomized double blinded and sham controlled study.
Francisco Silva: A total of up to 99, even eligible subjects will be enrolled at up to 16 clinical sites across the United States.
Francisco Silva: Subjects included in the trial wounds randomized two to one to receive either B R. A T X 100 or placebo.
Francisco Silva: In the presentation I gave it to 2025 Orthopedic Research Society annual meeting last month I reviewed 2652 week blinded data from the first 15 patients in the field and D.
Francisco Silva: The study enrolled in the trial.
Francisco Silva: No serious adverse events were reported and there was no dose limiting toxicity at 26% to 52 weeks.
Francisco Silva: Eliminate blinded visual analog scale or baas or.
Francisco Silva: West Street disability index of ODI data collected at 20 weeks 26, and 52 post injected injection demonstrated an exceptional positive trend compared to baseline.
Francisco Silva: We were also really excited to see that the 52 week comparison of MRI images to baseline demonstrated morphological changes.
Francisco Silva: Essentially demonstrate disc microenvironment remodeling.
Francisco Silva: These positive trends continue we believe that the phase two trial will meet its primary and secondary endpoints.
Francisco Silva: Partly based on the preliminary data we have.
Francisco Silva: Achieved two important milestones last month.
One of those was the FDA granted fast track designation for a D. O T X 100, chronic lumbar disc disease program.
Francisco Silva: Fda's fast track program is long to facilitate the development and expedite the review of investigational treatments that are designed to treat serious conditions and have the potential to address significant unmet medical needs benefits of the program include early and frequent interactions with the FDA to enter clinical development process and stem cell.
Francisco Silva: Product tankers with fast track designations may also be eligible for priority review and accelerated biologics license application approval won't BLA approval.
Francisco Silva: Cheating fast track.
Francisco Silva: Designation is an important milestone for virus started.
Francisco Silva: And we look forward to working more closely with the FDA as we continued to advance our lead T X 100 clinical program.
Francisco Silva: The FDA has also cleared our IND application for a phase III clinical trials would be our T X 100 targeting chronic cervical disc cucina claims or C. D D.
Francisco Silva: As a result, the BRT X 100 is now the first and only stem cell product candidate in the world cleared by the FDA to be evaluated in the cervical degenerative disc disease setting.
Francisco Silva: So we're leveraging our data related to our lumbar trial, you can now avoid having to perform preclinical animal studies and a phase one before initiating our phase III cervical study.
Francisco Silva: It follows that being cleared by the FDA to go directly into a phase two will be in a position to evaluate both the safety and efficacy of this product in the cervical disc saving potentially tens of millions of dollars in three to five years of animal studies and a phase one trial to get to this point.
Francisco Silva: This also allows us to be the only company.
Francisco Silva: <unk> to leverage our technology platform across both NEC and lower back musculoskeletal indications.
Francisco Silva: Moving to our clinical our core preclinical metabolic program done with them.
Francisco Silva: Developing cell based therapy tend to target obesity and metabolic disorders, using brown Abbott close our fat derived stem cells or <unk>.
Francisco Silva: Generally brown adipose tissue.
Francisco Silva: <unk> as well as Exosomes secreted by Brown adipose derived stem cells.
Francisco Silva: That is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans.
Francisco Silva: And is involved in weight loss.
Francisco Silva: Previously published peer reviewed preclinical data from a study conducted in collaboration with the University of Utah School of Medicine demonstrated that functional brown adipose derived stem cells formulated using our patented thermostat platform produced significant reductions in weight.
Francisco Silva: System with losses and achieved as with consistently losses are achieved by <unk> one drugs.
Francisco Silva: Glucose levels in diet induced obese models and life.
Francisco Silva: It is also important to note that although further work is needed to fully understand the mechanism of action is during this time.
Francisco Silva: Impact on weight loss and metabolism, we have not seen nor do we expect some negative secondary effects of <unk> pharmaceuticals, such as the loss of muscle mass and negative cardiovascular events as.
Francisco Silva: As awareness of the promise that our surface them B Braun.
Francisco Silva: Brown adipose derived stem cells for the treatment of obesity and related metabolic disorders continues to grow.
Francisco Silva: It's important that this potentially game changing opportunities well protected both for us and any crime and our future potential licensing partners to that end, we continue to methodically build a comprehensive portfolio of issued patents that covers both U S and international markets and we are pleased to see that.
Francisco Silva: Our already formidable IP estate expanded again in the fourth quarter.
Francisco Silva: On a final note our previously reported substantial discussions with an undisclosed commercial stage regenerative medicine company with regards to potential license agreement to a lesser extent metabolic disease programs are continuing.
While we cannot provide the interim progress updates will providing assurances that we will come to a mutually acceptable agreement.
Francisco Silva: We're committed to closing the loop on this.
Lance Alstodt: As soon as practical with that I will turn the call over back to Lance.
Lance Alstodt: Thanks, Francesco and as you can see from what Francisco and Rob just reviewed we have had a very exciting and extremely productive 2024, and we're energized by the many potential value enhancing inflection points. We see ahead, our financial results demonstrate that we're starting to make progress on our path.
Lance Alstodt: Sustainable profitability and we're continuing to focus on carefully managing our resources as we advance our two clinical development programs Bureau, T X 100, and star most down so to summarize we're making great progress with our phase III trial for <unk> 100 to treat chronic lumbar degenerative disc disease.
Lance Alstodt: And while the data is still blinded the initial trends are very encouraging.
Francisco Silva: Reflecting the positive preliminary phase II trial data seen to date. The FDA has now granted fast track designation to the program and as Francisco said, we will have the opportunity to sit in front of the F. D. A.
On a number of occasions, and really plan out what the balance of the trial and potentially what the phase III could potentially look like we intend to present more data from this trial with a larger patient population and we're optimistic that this data will be very consistent with the previous trends. We've now also expanded our.
Francisco Silva: <unk> clinical pipeline to BRT X 100 to include the treatment of both chronic lower back and neck pain via the FDA clearance of our IND for a phase two trial in.
Francisco Silva: In the surgical space, we are continuing to proactively expand the already formidable thermo scam intellectual property estate to help ensure long term market exclusivity and finally, we ended 2024 and a very strong financial position with cash cash equivalents marketable securities of <unk>.
Francisco Silva: Over $10 million as of 12, 31, 2024 will continue to efficiently manage our cash reserves, while executing upon all of our strategic goals, our steadily improving financial performance and our projected growth plans provides us with confidence around our financial flexibility.
Francisco Silva: <unk> and May put us on a pathway to become much less dependent upon the capital markets.
Francisco Silva: That concludes our.
Jenny: Prepared remarks Jenny.
Jenny: Yeah, No problem, we will now be opening the floor for questions. If he would like to ask a question.
Jenny: You can do say by pressing star one on your phone keypad now a confirmation tone will indicate that your line is and Nicky you May Press star two if you would like to remove your question from Nicky to any participants using speaker equipment, it might be necessary to pick up your handset before pressing the keys.
Speaker Change: See if I can do that mostly powerful questions.
Thank you. Your first question is coming from Michael Kuhn, who which of the Maxim Group Michael Your line is live.
Speaker Change: Hey, guys. Thank you so much for taking my questions today and congrats on all the great progress.
Speaker Change: Thanks, Michael appreciate it.
Speaker Change: So.
Speaker Change: I guess to start off just relating to the resolution of annular tears and a decrease protrusion size that you saw on the imaging.
Speaker Change: Is this.
Speaker Change: Something that you would expect to happen spontaneously or to patients with degenerative disks not typically improve on their own.
Speaker Change: Yes, definitely not it's not something that happens spontaneous, especially with annual her tears.
Speaker Change: In terms of like bold gene there is the possibility that can happen if it's like very degeneration and.
Speaker Change: Muscle changes are are are a factor that are that are affecting that.
Speaker Change: That indication or that bulge, but in our case, if it's degenerative disc disease, where.
Speaker Change: It's not muscle related to actually the disc as you're generating so.
Speaker Change: And Thats on the board, but deanna repair Theres a tear.
Speaker Change: Do not expect to see that so it's very encouraging that we're starting to see some resolutions here.
Speaker Change: Some of these indications with the subjects.
Speaker Change: And I would also add that what's encouraging is not only that there are annular tears that are resolved or resolution of other.
Speaker Change: Anatomical related issues, but the way in which they are being resolved youre starting to see sort.
Speaker Change: Sort of a more uniform lined in.
Speaker Change: In the imaging to demonstrate that there has been some actual regeneration. So again, we're blinded so I don't know, which whether or not that patient received.
Speaker Change: The product or not but there appears to be in the <unk> and indeed in the study and in the imaging a very uniform.
Speaker Change: Resolution of the of the terror and in a format that would suggest that some.
Speaker Change: Outside product could have potentially been the rationale.
Speaker Change: Alright, thank you for that.
Speaker Change: And then thinking about.
Speaker Change: The cervical program right, so you're moving from lower back looking at cervical do you view this more as something of a one off expansion thats opportunistic or is there a broader strategy to be should be thinking about to expand BRT X 100 over time to these other musculoskeletal indications where the hypothesis.
Speaker Change: <unk> may be less favorable to other yourselves.
Speaker Change: Yes, I think that's that's the that's the goal.
Speaker Change: We want to we should typically chosen the cervical space because it just makes sense if it's working for lumbar it should work for cervical.
Speaker Change: There are some adjustments that we have to contemplate in terms of the volume of the disk that we've already we've already addressed and Thats why we have the R&D approved.
Speaker Change: But I think you know looking at the Big picture, if we could get through the process and get PRT X 100 approved we're looking outside of the spine. So just as you mentioned like anything that has a hypoxic nature to it.
Speaker Change: This cell is amenable to two having a good therapeutic value to that.
Speaker Change: So that particular treatment.
Speaker Change: Okay.
Speaker Change: And also leveraging all that data that we see from lung from from lumbar I think puts us in a position to get further along the regulatory pathway with cervical so being able to eliminate a lot of time and costs associated with getting into that that particular factor.
Speaker Change: That particular label if you will.
Speaker Change: Yeah, I mean, just to add to that is the.
Speaker Change: We did that we went directly to phase two with a number which was a huge accomplishment for the company.
Speaker Change: In the field actually because it had not been done before in that format.
And now we've leveraged our our lumbar data, which included both safety and efficacy to the FDA and we got a phase two proof for cervical so.
Speaker Change: You know, it's it's it's definitely moving in the right direction in terms of potential treatments and then furthering applying it to other more Cisco two indications.
Speaker Change: Yes.
Speaker Change: <unk> down that down that line right you do plan to go straight to Phase III. You have mentioned you expect this to be somewhat of a smaller study so.
Speaker Change: Is there any and here to potentially designed as a registration enabling study similar to your plans in lumbar disc disease.
Speaker Change: Yeah, absolutely that's.
Speaker Change: Building upon the strategy. So it just we need to get our history with the FDA on the clinical path.
Speaker Change: We've received fast track designation and anatomically, although the cervical is different than the spine is still to the lower back is still a spine. So I think we're going to be able to leverage a lot of the regulatory.
Speaker Change: Hurdles will jumping through the lumbar trial.
Speaker Change: With the spine and we could get faster regulatory approvals for both programs.
Speaker Change: Alright. Thank you very much for taking my questions today, guys and once again congrats on all the progress.
Speaker Change: Thanks, a lot Michael Thanks, Thanks, Michael.
Speaker Change: Thank you very much just to remind you that if anyone have any remaining questions in the audience. You can do so by pressing star one on your thank you Pascal.
Speaker Change: Thank you. Your next question is coming from Elena <unk> of Rodman and Renshaw LMR. Your line is live.
Elena: Thank you Lance I am sorry, I joined a little bit late than you may have provided an enrollment update in the lumbar trial.
Speaker Change: If you wouldn't mind repeating that and.
Speaker Change: What would your estimation before completing this first 100 or 100 patients that you are planning to enroll and the follow up would be where you are.
Speaker Change: Estimating the cash burn in 2025 to be similar to 2024.
Speaker Change: Sure. So I think I'll take the cash burn question first I think it will be similar.
Speaker Change: As we will be continuing to enroll patients, possibly possibly even a little bit less I think 2026 will certainly be less because we won't be enrolling at least as it relates to <unk> 100.
Speaker Change: Lumbar.
Speaker Change: We havent given out numbers on enrollment, but I will tell you that.
Speaker Change: We are considering giving out some numbers shortly enrolled.
Speaker Change: Enrollment is going very well.
Speaker Change: The reason why we're not giving out numbers, because we don't want to give an indication as to how far.
Speaker Change: We are from or how far or how short we are from completion and that we are exploring some regulatory opportunities and strategies that dovetail with our.
Speaker Change: With our fast track designation with the FDA to explore the potential to shorten the trial limit the number of patients.
Speaker Change: And seek.
Speaker Change: A accelerated regulatory path.
Speaker Change: I'd like to have the benefit of having that meeting speaking with the FDA getting more clarity on what that looks like before reporting back.
Speaker Change: Stan Thank you very much Matt.
Speaker Change: Thanks AMR.
Speaker Change: Thank you very much just to check if there's any other questions from the audience here.
Speaker Change: Star one on your phone keep happening.
Speaker Change: We do have another question in from Michael of the Maxim Group.
Speaker Change: Michael Your line is live.
Michael Maxim: Hey, guys. Thank you for taking another one from me just couldn't get enough of us.
Okay.
Speaker Change: I always love talking to you guys.
Speaker Change: Yes, So let me let me think about the car test their revenues going forward right I know it was <unk>.
Speaker Change: So you expected somewhere in the range of the low single digit millions.
Speaker Change: Is this something that we should expect to be kind of lumpy going forward are more consistent.
Speaker Change: Yeah, I mean I think this was just.
Speaker Change: Look we this is our first foray into a commercial relationship.
Speaker Change: With a company that's not a biologics company, rather a laser a distributor who has you know now.
Speaker Change: We enhanced their biologic sales force learning about the product learning what the right call point is really figuring out the strategy on selling so I would expect that going forward it would be a little bit more consistent.
Speaker Change: To some of the numbers that we gave but.
Speaker Change: Again, I don't want to get ahead of myself here.
Speaker Change: This is this is this hasn't even been a year since we signed the agreement so like like all things. It just takes time to build that.
Speaker Change: We're very encouraged by their commitment to us.
Speaker Change: We have the flexibility and opportunity to drive. This this this product, albeit with a slightly different formulation.
Speaker Change: Through other distributors as well we will most likely.
Speaker Change: <unk> be talking about or having an announcement related to some commercial opportunities shortly related to this this product category. So I'm really excited I, just I don't want to put the cart before the horse here, but in terms of human resources and senior level personnel.
Speaker Change: Talking to some very experienced people that can help drive this opportunity for us.
Speaker Change: And theres more to come on that so I wouldn't focus exclusively on car Tessa I think they will continue to be.
Speaker Change: A good partner for us, but I think that the opportunity for the bio Kosmos <unk> platform. It goes well beyond that relationship.
Speaker Change: Alright, Thank you very much.
Speaker Change: Okay. We appear to have reached the end of our question and answer session I will now hand back over to the management team for any closing remarks.
Speaker Change: Thanks again for everyone for your interest and your participation in the call and to the equity research analyst that asked excellent questions. We appreciate that as well.
Speaker Change: Please continue to follow us once again this is a very catalyst rich environment for the company. So keep us on your on your screen and.
Speaker Change: Please look out for further for recent developments that are that are that are coming soon thank you very much.
Speaker Change: Thank you everybody. This does conclude today's conference you may disconnect. Your phone lines at this time and have a wonderful rest of the day. Thank for your participation.