Welcome. This is the Enlivex webinar. We'll be getting started in less than five minutes at 8:00 A.M. U.S. Eastern. Our check is complete, Oren. Yes, good. You've already muted yourself. That's just fine. If you would come on at, like, a few seconds before 8:00 A.M. Eastern, I will then get everything started by introducing you and Shai, reading the safe harbor, and then giving you the floor. Hello, everyone. This is Craig Brelsford with RedChip Companies. Thank you for joining today's event with Enlivex Therapeutics, which trades on the NASDAQ under the ticker ENLV. With us today, we have Oren Hershkovitz, the Chief Executive Officer of Enlivex, and Shai Novik, Chairman of Enlivex. We will begin with a presentation in a moment, and then we'll open the event to your questions. You may submit your question at any time.
Click the Q&A button at the bottom of the Zoom window. Before we begin, please allow me to read the safe harbor statement. This call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact should also be considered forward-looking statements. Of course, forward-looking statements involve risks and uncertainties. I now turn the webinar over to Oren and Shai. Please go ahead.
Thank you very much, Craig. Hello, everyone. Very happy that you joined this exciting event. For those of you who are less familiar with myself and Shai, I'll start with a quick intro, presenting myself, and I'll ask Shai to do this as well. We can dive in directly into the top-line data of our face-to-face study. My name is Oren Hershkovitz. I'm the CEO of Enlivex in the past six years almost. I'm, obviously, by training, been doing drug development for many years, prior to joining Enlivex. I managed a company called OPKO Biologics. I led a team for five years working tightly with Pfizer on late-stage development of a leading asset, which is a long-acting [growth hormone]. It was eventually submitted and approved in many countries. This was actually a company that Shai founded.
I'll ask Shai to take you a little bit into the story because it's a very, very successful and important one to know us. That's it. Shai, please go ahead.
Sure. Thank you, Oren. Again, as Oren said, for those of you who are less familiar with the top management at Enlivex, this is our second company that Oren and I are doing together. The former one was named Prolor Biotech, which I founded back in 2005. We e-licensed some technology from Washington University in St. Louis and really started as a garage startup. We took the company public on the New York Stock Exchange in 2010. We sold the company in 2013 to OPKO Health. That was a $590 million transaction. At that time, OPKO asked us to stick around and run the company post-acquisition, which we did. We signed a partnership agreement with Pfizer for our lead product, which was a post-phase II asset. We received, at that time, $295 million. Just the down payment was a very substantial deal.
Pfizer continued with the clinical development with the help of Oren and the team at what became OPKO Biologics. As Oren said, we're very pleased to just report historically that the product that we developed is now called NGENLA by Pfizer, has been approved in more than 43 countries, including the big markets, Japan, all over Europe, and the United States last year as well. I then co-founded Enlivex. Once I did that, I asked Oren later on to join as CEO and kind of the rest is history. I think this is fine just for, you know, kind of reintroducing ourselves to you guys. We want to share with you today something that is very exciting to us, at least.
We've been waiting for a long time for this to show the potential effect of our drug, Allocetra, in a problem that has no real solutions and affects so many people in the United States and all over the world. I'm going to hand over to Oren to take us through the presentation. I'm going to chime in every now and then with a few slides. Thank you, Oren.
Thank you, Shai. Extremely excited here to present the top-line data from our face-to-face study, as I said. We're going to go through the deck and go through the results, the exciting results. For those of you who are a little bit less familiar with the company, just a quick overview about Enlivex. Stay with me patiently for a second, and we'll get there to present the top-line data in a few slides. Again, for those of you who are a little bit less familiar with Enlivex, a quick overview about this very unique company. We're a clinical-stage company focused on really a completely novel approach to treat inflammatory diseases, which is modulation or reprogramming of unique immune cells called macrophages. Those cells are involved in many inflammatory diseases. Using our platform, we know how to affect their activity.
To the best of our knowledge, no other company is using a similar approach as we do, targeting those cells. This is really a completely new modality. We're using this approach to target substantial markets with defined unmet medical conditions, such as osteoarthritis. We'll get to that in a second. It's a very good example. Besides the fact that we're very unique in our modality, what makes this cell platform very, very, very unique is the fact that it's really cost-effective in a way that is completely different from any other cell therapies out there. This means that it's what we call an off-the-shelf drug. It's very, very cost-effective because we have a very simple manufacturing process, very simple to produce these cells.
Eventually, if we're talking about osteoarthritis, our projection is it will be, in terms of pricing, completely competitive to drugs that are out there that are being used, although not very effective, will be very competitive in pricing as well. This is a very important factor. That's a quick overview about the modality, the cell platform that we're using. As Shai said, Shai and myself, this is our second round together. The founder of Enlivex, the scientific founder of Enlivex, Professor [Dror Mevorach], who's a well-established scientist and a physician that developed the technology in the management of Enlivex. We also have Einat Galamidi , our CMO, who led the development of a cell therapy in a company called Gamida that was approved by the FDA.
What I'm trying to say here is that in the management of Enlivex, we have a very seasoned management with a lot of experience from the business perspective and from the development perspective, taking drugs all the way from preclinical to approval. Maybe to add to that is the board of directors. Besides Shai being our Executive Chairman, our Vice Chairman, Roger Pomerantz , who's a former head of licensing acquisition at Merck, was a venture partner at Flagship. All of these board members are working together with a lot of vast experience from all the aspects that are required to take such a company into the late stage. What we'll present today, as you may understand already, is the top-line, three months top-line data from our face-to-face study in knee osteoarthritis in patients with moderate to severe knee osteoarthritis. A few words about osteoarthritis.
Osteoarthritis is the disease that results in cartilage damage, abnormal bone remodeling, and such, and eventually a lot of pain. Many of you that are listening to me now are familiar with this just because they're experiencing this. This is one of the most common life-debilitating diseases. It's considered by the FDA as a serious indication. The market is just, you know, it's huge. It's really huge. We're talking about 32 million adults in the U.S. suffering from osteoarthritis, the majority of them from knee osteoarthritis. As a consequence, the market size now is about $7 billion. It's expected to grow to around $15 billion already in 2030. What's remarkable about this is that we don't have effective therapies for these conditions.
Eventually, patients are taking pain reliefs or steroids, which are not, you know, they cannot use for long-term treatment, and eventually are going through surgeries and knee replacement therapies and such. There's a huge need for a huge market. This is exactly based on the data you'll see in a second where Allocetra steps in. One of the main reasons that this market continued to grow in such a dramatic way is the fact that we're aging. Actually, osteoarthritis prevalence with age increases dramatically. As you can see in this graph, age groups of 60 and 70s and above, we're talking about a prevalence of about 40%. This is really the majority of the population that suffers from osteoarthritis, from symptomatic osteoarthritis. Enlivex phase `II, I-VIII study, that was a multi-country, multi-center study.
It was a randomized, double-blind, controlled trial to evaluate Allocetra in patients with moderate to severe knee osteoarthritis. This is an important slide that I want to pause for a second to explain. It's very complicated the way it looks, but actually, what happened is when we sat down to design the phase I-VIII study for the knee osteoarthritis in moderate to severe patients, we sat down with the experts, right? We're working with the leading, what we call key opinion leaders, experts in osteoarthritis. They conveyed to us that we should consider the fact that osteoarthritis is not a single molecular disease. It's actually a syndrome, which means that we have a heterogeneous population, right? We did take that into account in the study design. What we actually wanted to do is to include those populations.
Besides assessing safety and efficacy, we wanted to potentially find a strong signal in our responder subpopulation that will guide us to the future development. This was part of the way we designed the study. It is a face-to-face study. It made sense to identify that group now and to continue to the late-stage development. We took into account various factors and the baseline factors and so on. We actually implemented it in study design. Again, this looks very complicated, but I'll simplify it. We've implemented in the study design an interim analysis, which was independent and was outsourced to a different company that aimed to identify a subpopulation of responders. A highly responder subgroup, that subpopulation that, based on various factors, are actually responding to the drug, right, to Allocetra.
Eventually, we had this algorithm that allowed us to identify that subpopulation and even, in some cases, to inform us how to increase the sample size to larger numbers in order to get a statistically significant result. This was embedded in the study design and in the targets and the objectives of the study. What I'm very, very happy to say is that we actually met the objectives of this phase II-A. We had a favorable safety profile with a positive effect. We identified high responders, which represent more than 50% of the knee osteoarthritis market. They were not only more than 50% in the population in our study, but they're actually representing in the overall knee osteoarthritis market. They're representing more than 50% of the population, which in this group is aligned with our proposed mechanism of action.
This made us extremely, extremely excited because we know how difficult this, you know, in this very serious and unmet medical condition, how difficult it is to see such a strong signal, as you will see in a second. In terms of the study design, this was a two-stage trial design, OK? Again, moderate to severe osteoarthritis patients, age range between 45 - 80. We included all this range, age range. The study consists of two stages. The first stage was a safety run-in, a dose escalation safety run-in. Following this stage, we had an independent safety committee reviewing the data and saying, OK, you have no safety signals here. The highest dose that was selected, as well as the lowest dose, showed a similar safety profile. You can move on to the phase II part of the study, which would actually be the highest dose tested, right?
This was very encouraging. By the way, we've published the three-month and six-month data from this phase I, which, as you might remember, demonstrated already very promising safety and efficacy data. That was encouraging, but we were waiting for this stage that I'm going to talk about now, which is a phase II-A, a randomized, double-blind, placebo-controlled stage. We overall recruited 134 patients to this stage. They received three injections of Allocetra or placebo two weeks apart, so over our one-month treatment period. The endpoints for this study were, you know, this was the phase II-A again. The primary endpoint is safety, of course. We had secondary endpoints that were change in pain and change in function compared to baseline, right? The time points that we evaluated were three months and six months, and overall for safety, even 12 months.
The objectives here are, again, and I want to reiterate that message, were to assess safety and efficacy and to see if we can see reduction, right, in pain, increase in function, and reduction in stiffness of the knee. This was assessed using a numerical grading questionnaire. I'm going to use the term WOMAC throughout a little bit throughout the presentation. It's important to understand that WOMAC is a questionnaire, which is a validated endpoint for a phase III registry study. The endpoints in this study are aligned with the FDA expectation for endpoints for a phase III study. Now, this questionnaire assesses pain, function, and stiffness, the different subcategories in the assessment.
This is the demographics of the study, overall well-balanced between the Allocetra treated group and the placebo group across all the different parameters that you're seeing here, as well as age and any other parameters we evaluated, as you would expect in a study of this size. Before I'm presenting the actual results, we need to go through a medical definition, which is primary idiopathic OA and secondary OA. As you recall, I said we saw a responder subgroup. This primary OA stands for the classical majority of osteoarthritis resulting from the wear and tear effects that happen to the joint. It's associated with low-grade inflammation. It's age-related mostly. We defined it in our study as above the age of 60.
Also, the secondary osteoarthritis is all the rest that could result from trauma, misalignment, and bad repair and this type of events that usually start at earlier ages and has a different immunological pathway than the primary idiopathic OA. That's important. We define that as an age group of below the age of 60. The top-line three months data, and we're looking now at pain. What we saw is a 24% positive effect in WOMAC pain across the study patients, which you can see here on the left-hand side. When we look at the primary osteoarthritis population above the age of 60, we're seeing a dramatic, substantial, statistically significant and clinically meaningful effect already now in this phase II-A study. You can see the change from baseline at Allocetra group versus the placebo group. The effect size was a 72% effect over the placebo group.
It was highly statistically significant, as reflected here in what we call the p-value. Overall, we had more than 54% of the subject in this category, right? That's the majority of the patients in the study responding very highly in terms of the effect size, in terms of the statistically significant effect, in an endpoint, which will be eventually our phase III endpoint. Already in this population here, we're seeing a dramatic effect. I think you can see how excited we are about these results. Just to continue what we saw, this was a clinically meaningful, statistically significant effect, not just in the pain change from baseline, but actually across all the efficacy endpoints we evaluated in the study in primary osteoarthritis patients. You can see here on the left-hand side, we're seeing the phase III primary endpoint.
Change in pain, using again the WOMAC, change in pain or change in pain and function in both of those endpoints, the one that I show you now with 72% effect size over placebo. When you look at the pain and function, which again are phase III endpoints, we saw almost 100% effect. What you're seeing here is that across all of those endpoints, we saw a highly statistically significant effect. In terms of the absolute change, this is aligned with what we taught and reported in our previous phase I in our previous reporting on the phase I part of the study. We're seeing a 50% reduction almost in all of those endpoints. The last slide here, the last column of the slide, sorry, is what is the magnitude of the effect over what FDA expects for a phase III endpoint.
What's the minimal effect size that FDA expects versus what we're seeing? We're seeing something like 90% more effect already now in a phase III endpoint. We're totally excited. We really met the objectives here as we were planning to. Maybe, Shai, you want to take us through the next two or three slides because I want you to share the same with the rest of the group.
Sure, thanks. We continued with the analysis and wanted to understand whether what we're seeing was specific for the age cutoff. If it's, I don't know, if it's 61 or 63, maybe the numbers would not look as good or something like that. Maybe it would create some, you know, in our minds, some questions whether, you know, maybe we're not seeing something here. We looked at the different age groups. As you can see here on the left-hand side, this is what Oren just showed you, which was a 72% better performance than placebo in reduction of pain. In the middle, the cutoff is the age of 63 and above. There in that group, the pain reduction is already 183% better than placebo. The statistical significance is still, even though initially it was very strong, gets even stronger.
When you get to the age of 65 and above, you can see that the effect above placebo is 217% reduction in pain. The statistical significance continues to increase, right? That's in reduction in pain. Oren, if you can move to the next slide, this is not just pain. This is if we look at a combination of pain, stiffness, and function altogether. You can see on the left-hand side that there is a 90, if the age of 60 and above, that primary osteoarthritis group, you see 92% highly statistically significant difference between the placebo and the Allocetra group. When we move to 63 and above, it grows to 237% difference better, even better statistical significance. If you do 65 and above, you get 350% better in terms of improvement in the knee with, again, better statistical significance.
Oren, if you can move to the next slide, I think this is the one slide that I personally, this is my most favorite slide of this presentation of the data. It's a little complicated, so I'm just going to spend a minute on it. On the y-axis, we see the excess reduction in two FDA phase III endpoints that the FDA would like to see: pain reduction and pain and function, OK? Improvement in pain and function. You can see on the y-axis, you can see the excess reduction in pain and better improvement in function, OK? That's on the y-axis in the Allocetra group versus the placebo group. On the x-axis, you see just cut off, you know, the age of 60 and above, 61 and above, 62, 63, 64, 65 and above.
What you see here, you see a very clear demonstration of clinically meaningful, statistically significant, substantial effect size, much, much, much multiples better than placebo. It trends with age. As you can see, it goes up with age. By the way, each point here on each of those curves is highly, highly statistically significant, OK? It is not just very impressive positive delta versus placebo, but highly, highly statistically significant. To us, this chart made a lot of sense because as your symptoms started at a later age, it really means this is age-related osteoarthritis. This is not something that happened to you when you're playing basketball at the age of 42. At the age of 51 or 55, suddenly you have a different type of osteoarthritis. This essentially caused us to be quite comfortable with what we're seeing here.
It is all aligned to us with the potential value of what Allocetra brings to this group, which we call the primary osteoarthritis group. Oren, if you can move to the next slide.
Yeah. OK, to summarize what we saw to this point, right? We're seeing a highly responder population, which we defined as primary idiopathic osteoarthritis. It's age-related. We're seeing that statistically significant, meaningful effect at the age of 60, and it actually trends up as we go up with age, as you saw. The question was, you know, what's the mechanism here? I don't want to take you too much into the science. What I can say is that we know that in primary idiopathic osteoarthritis versus secondary osteoarthritis, we have different modulation of the inflammatory condition that leads to the development of that disease. We have different cells, different types of macrophages, different types of other immune cells involved in those two different pathways. We think that what we're seeing here makes sense from and is consistent with the proposed mechanism of action of Allocetra.
It's not just because we identified that subpopulation. It actually makes a lot of sense for us from a mechanistic point of view. In terms of the safety profile, Allocetra demonstrated a favorable safety profile. We had no serious adverse events that were reported linked to the drug. We had overall very favorable safety profile. As I said, we had an independent safety committee reviewing the data in the interim analysis. Actually, also following three months top-line data, they went through the safety profiles with no safety signals whatsoever. What we did see is, like observed in earlier clinical data in severe osteoarthritis patients, we saw some local responses following injection. Mostly, we're talking about some knee pain and discomfort. This is very typical to intra-knee injection, especially cell therapies and such. What's important is that events were usually mild to moderate. They were transient.
Patients were advised to take a pain relief if they needed to. Overall, it was treatable and transient. Also important to say is that it didn't lead to any dropouts or anything like that. Overall, very favorable safety profile that allowed us to continue to the follow-up study. Talking about next steps, right? All you saw up to now is, again, it's really exciting because this is an unmet medical condition. It's a serious condition, no effective treatment. I think what we're seeing here makes us extremely passionate about pushing this program forward as fast as we can because we can actually provide a solution for those primary osteoarthritic patients potentially. How would the next study look like? We're talking about the planned phase II-B study. It will be a randomized, double-blind, placebo-controlled, multi-country study. The focus at this study will be primary idiopathic osteoarthritis patients.
We're assuming age of 60, 65, and above. This is more than 50% of the total knee osteoarthritis patient, right? If we're talking about 14 million, for instance, adults with knee osteoarthritis in the U.S., we're talking about more than 7 or 8 million patients just in the U.S., right? The study, the phase II-B, will follow the same route of administration and dose regimen, which means three injections of Allocetra versus placebo every two weeks, three injections in total. We're assuming about 75 patients per arm. We did, we're not presenting this here, but we did what we call sample size calculation based on the data we currently have. As you saw, we already have in the current study statistically significant and meaningful effect. 75 patients per arm is probably, as expected, to provide a very meaningful and statistically significant outcome.
The primary endpoints in this study will be three months change from baseline in WOMAC pain. I think by this time, you understand what WOMAC is, the validated questionnaire, the phase III validated questionnaire, or a combination of WOMAC pain and WOMAC function. Both are FDA acceptable and expected endpoints. Safety and tolerability, as well as secondary endpoints such as the NRS and other endpoints that we will assess. This is kind of, I guess, a roadmap that's presenting our short and long-term target milestones. I'll walk you quickly through all of this. We're expecting the six-month readout from the current phase II-A study around November. The phase II-B, we do expect to have the regulatory approval the Q1, Q2 2026. The first patient dose Q2, Q3 2026. We'll have the phase II-A 12-month readout. As I told you, we're doing a safety follow-up and additional assessments.
That's expected the Q3 2026. We're expecting to complete enrollment beginning of 2027. The three-month top-line data coming at Q2 2027. The six-month top-line data at Q3 2027. Now, we're planning to initiate, now that we have this exciting data, we're planning to initiate or even to take it one step further, our potential collaboration with partners. We're initiating partnership discussions. We think, you know, for us, this is very similar to the point where we were at Prolor as Shai shared with you before. We had a phase II data, which allowed us to go, you know, based on a randomized control study, allowed us to go to in-depth discussions with potential partners. That's exactly what we're planning to do with this data.
Oren, maybe I can.
Sure, go ahead.
Just another word on this. All of you who are on this webinar are probably veteran investors in small cap and in pharma and biotech. You all know that sometimes there is a delta between data that Wall Street, how Wall Street reads data and how pharma, I mean, larger companies read data. We are quite pleased. It's our opinion and our belief that we will have, I think, a lot of interest to listen to the story and go deep into this data. This data, we think, is of very high quality. If you look at the classical product development framework, I think that we are in a very good position to demonstrate the potential value to the very specific population that represents more than 50% of the total market, which is a huge market on its own, which is an unmet medical need.
Oren is going to show you momentarily why we're also very excited about the cost element of our product. Maybe, Oren, you can skip to that.
Sure. To summarize what we saw from the three-month top-line data, study objectives were met. Allocetra demonstrated a favorable safety profile. No related assay is available, as we discussed. We saw a 72% average positive effect in pain reduction and almost 100% in increased function, which are all phase III endpoints, clinically meaningful with high statistical significance of intended phase III endpoints and the planned phase III population. As well as across all other secondary endpoints, we had a positive effect that exceeds what we believe to be the FDA minimum threshold by more than 65%. Robust and consistent effect aligned with our proposed mechanism of action of the drug. Osteoarthritis is a growing market with significant potential unmet medical conditions, with primary osteoarthritis responders representing more than 50% of the $7 billion market today. It's expected substantially to grow.
We have a very simple manufacturing process, which is highly attractive in terms of the total cost of goods, right? The pricing of the drug, we estimate to be around $450 on average for the complete treatment, allowing us to be very competitive in pricing, which will be well within what's currently out there. It's not recommended by organizations and guidelines that guide the treatment of osteoarthritis. Nevertheless, what we're facing here today is that orthopedics have no other alternative. They do treat patients with several non-officially recommended drugs. We will be competitive completely to those high-end solutions. As you saw today, with much more effective treatment and safe. Based on that, we believe that Allocetra has the strong potential to become the therapy of choice for primary osteoarthritis, knee osteoarthritis patients. With that, we'll conclude the presentation. We'll be happy to take questions from you.
Yeah. Oren, I see that we have already several questions from the crowd. Maybe you want to start taking those just one after the other. I'll join you.
Sure. Let's start with the first one. The question is, what are the next steps following the three-month data readout? As I said, first of all, we continue with this study, right? We are expecting to have the six-month data readout, as I said, around November, and to continue to follow those patients all the way to 12 months for a safety perspective. In parallel, what we're planning to do is to finalize now the protocol for the phase II-B study that I presented and initiate the regulatory submission for that study. We're expecting, based on these results, to be able to initiate the study early next week, or hopefully early next year. I guess that will be the next coming steps. That's one.
There's a question about what is our strategy to attract potential partners. Maybe I can take that one. I think that, look, what we've done at Prolor was that we have presented data which we thought was very sound and solid to different potential partners at that time. We were able to start driving a process with a few of them that essentially culminated in a deal with a partner that, from our standpoint, was really the best partner to make the drug that we developed at the time to be a leader in the market. I think this is what we would like to try and do here, not just discuss this with one potential partner, but show the data, which again, we believe is very strong and solid to multiple potentially interested parties and take the process from there. Where is this going to end?
I mean, you know, we never know. We're definitely going to start the tour, basically, effectively starting at the end of September.
OK. Next question. What are the differences in the macrophage population or inflammatory characteristics between primary OA and secondary OA, where the change in pain was not as robust as seen in the secondary OA? I think that's a very, very good question. We know that there are differences in the type of macrophages that play a role in those two different primary versus secondary OA. We know that resident macrophages, for instance, play a more significant role in the primary OA, whereas in the secondary, we have also recruited macrophages. We know that those two types of populations are different in the way they, for instance, in the receptors that they engulf, apoptotic cells, and other differences. I don't want to get too much into science here, but I think that clearly there are differences.
Based on what we're seeing here, it makes sense to us that it's aligned with what we think the mechanism of action was, et cetera.
Oren, there is a question here from one of the Wall Street analysts. It says, congratulations on the impressive data. Has the FDA signed off on the potency assay for Allocetra cells? Maybe you want to take that.
Yeah. Maybe first to explain to the audience what potency assay means. I'm not sure everybody is familiar.
Very quickly, yeah.
Potency assay means an assay that evaluates the activity of your drug. It's a very, very important assay. The FDA expects this assay to meet very high standards. I can say that we already discussed with the agency about a potency assay in the past. The overall proposed assay is acceptable with the agency. The answer to that basically is yes. This is an ongoing discussion, as always.
Yeah. There's another question here, which I find very interesting and relevant. You beat placebo, but what are the equivalent results from competitive products that you need to beat to be commercially viable? Maybe I can start, and then Oren, you can chime in. The thing is that, unfortunately, for us as humans, and maybe it's very good for Enlivex as a company, there are no really good solutions today for knee osteoarthritis. You go into the physician's office and you say, you know, I have this. It's painful, whatever. Can you give me something? You do an MRI, and it's osteoarthritis. Essentially, you start getting a series of treatments because they need to provide you with something. You may get an injection of steroids, and you may feel very good for a month or two.
After that, it's not going to be as good, and you'll continue to deteriorate. You're going to get, you know, some other injection, something else. At the end of the day, it's not an industry that there are three amazing drugs, and we are the forthcomer to that, to that industry. Now we need to show dramatic superiority, above everybody else. I think that this is, you know, if this continues to present itself in a phase III and we get the product approved, I think that Allocetra would be the leading product in this industry. Oren, do you want to take another question?
Yeah. We have a question about what are the financial plans. It's a very, very good question and very relevant, right? We had $20.6 million according to our last report in March. This cash position reflects the fact that we've introduced substantial efficiencies in our operations and strategic focusing in the past two years. Considering the positive cash position, the projected cost of the phase II-B study, taking into account also the reduced burn rate, in order to get to the next inflection point, which is the three-month and six-month top-line data from the phase II-B study in mid 2027, this could be achieved using mostly the existing cash. The remainder could be financed by several alternatives, wise use of our ATM, non-dilutive funding opportunities, by the way, which we're currently actively pursuing as we speak now.
As we said, also potential partnership, which may occur and fund the additional clinical development and obviously other potential financing opportunities. That's currently.
I think we're running almost out of time. Maybe we can take another final question if you think.
Sure. Nice, Oren and Shai. Why do you think the age makes the difference? What is the durability of the positive responders? That's a good question. I think we tried to explain what we think. We think that what we're seeing here is what we call primary idiopathic OA, osteoarthritis that results in a low-grade inflammation. It's associated with age, as we explained before. That's why when you have these different types of inflammatory cells, different types of macrophages, you have a different profile than secondary OA, which is, again, presumably aligned with the way Allocetra works, right, in a low-grade inflammation environment affecting specific resident macrophages. We have data from other indications showing that.
I think what we're seeing in age is actually, since as Shai explained, when you go up the age and we're seeing more stronger signals, this is because they're actually more idiopathic, more classical primary osteoarthritis patients. We have additional data. We cannot go through this here, which correlates to other parameters that we're seeing that also suggest the same. In terms of the durability of the response, we only have partial data from the six months. We're seeing the same trends at this stage. It's a little bit too early. We'll wait for November to see the totality of the data. We're seeing a similar trend in six months as well. Right.
Yeah, I think we ran out of time. Craig?
Excellent. Thank you very much, gentlemen. For more information on Enlivex Therapeutics, reach us at 1-800-REDSHIP or email us at enlv@redchip.com. Please visit the information page created by RedChip for Enlivex. It's enlvinfo.com. There you can view and download the investor presentation and fact sheet and sign up for news alerts. Sign up for news alerts on Enlivex. RedChip is excited to announce the launch of RedChat, our advanced AI assistant designed to empower investors with instant in-depth insights on 4,000 small cap and micro cap stocks. Try it now on enlvinfo.com or go to red.chat. Watch "Small Stocks, Big Money," RedChip's program featuring exciting small cap companies every Saturday night at 7:00 P.M. Eastern on Bloomberg USA. Finally, join RedChip's next webinar with ASP Isotopes on Thursday, August 21st, at 4:15 P.M. U.S. Eastern. Register for all RedChip webinars at redchip.com/events. Thanks again to our many participants today.
Thank you, Oren and Shai.
Thank you very much.
Thank you very much. Thank you, everybody, for listening. I appreciate your time. Thank you.