Lisata Therapeutics, Inc. (LSTA) Q3 2020 Earnings Report, Transcript and Summary

Welcome to the Caladrius Biosciences' Third Quarter 2020 Financial Results and Business Update Conference Call. Currently, all participants are in listen-only mode. Following management's prepared remarks, we will hold the question and answer session. [Operator Instructions] As a reminder, this call is being recorded today, Thursday, November 5, 2020. I'll now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Caladrius. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. Welcome to Caladrius' third quarter 2020 conference call to discuss our financial results. Joining me today is Dr. David Mazzo, the company's President and Chief Executive Officer. Earlier today, we issued a news release announcing our third quarter financial results, which is available under the Investors section of our website. If you have not received this news release or would like to be added to the company's email distribution list, please e-mail me at jmenditto@caladrius.com. Before we begin, I'll remind you that the comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Caladrius. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its forms 10-K, 10-Q and 8-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, Thursday, November 5, 2020. Caladrius Biosciences undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. Please keep in mind that the company continues to conduct calls from different locations during the COVID-19 pandemic, so we appreciate your patience, should we have any technical difficulties. With that said, I will now turn the call over to Dr. Mazzo. Dave?

Thank you, John, and good afternoon, everyone. First of all, I hope all of you are in good health and are remaining safe. And thank you for joining us today on our third quarter business update conference call. As we entered the final stretch of what has been historically challenging year for the world due to the COVID-19 pandemic, I could not be more proud of the relentless focus, dedication and resolve shown by the Caladrius team to deliver strong operational performance during another highly productive quarter, while maintaining a strong financial position that will fund operations through the end of 2021. Despite the challenging environment brought on by the pandemic, we delivered on a number of strategic priorities in support of our robust CD34+ cell technology based clinical programs, on which I will further expand in a few moments following my review and comments on the financial results. Before that though, I will take a moment to welcome Anne Whitaker, as the newest member of our Board of Directors. Anne brings an abundance of leadership experienced notably in business development and corporate strategy that will prove invaluable as we continue to drive the evolution of our company. And with that, I will now review and provide commentary on our third quarter financial results. As you may recall from our previous quarterly update calls, we closed on the sale of a portion of our qualified New Jersey net operating losses nearly $10.9 million of non-dilutive capital pursuant to the New Jersey Economic Development Authority Technology Business Tax Certificate program. The entire $10.9 million was recorded in the second quarter of 2020 results as a tax benefit, resulting in the company reporting a net loss of $2.7 million for the nine months ended September 30, 2020, compared with a net loss of $14.4 million for the nine months ended September 30, 2019. Turning to our operating expenses, research and development expenses were $3 million for both the three months ended September 30, 2020 and September 30, 2019. R&D expenses for the nine months ended September 30, 2020, were $6.3 million, representing a decrease of 21% compared with the prior year period. R&D expenses comprised of cost associated with the investigational new drug application and planning for commencement of a pilot study of CLBS119, execution of expenses for our ongoing registration eligible study for CLBS12 or HONEDRA in critical limb ischemia in Japan, and expenses for both the completion of our ESCaPE-CMD study and CLBS16 in coronary microvascular dysfunction and planning for the follow on Phase 2b, which we have now named the FREEDOM study. General and administrative expenses, which focused on general corporate activities, increased 12% to $2.3 million and 5% to $7.4 million for the three and nine months ended September 30, 2020, respectively, compared to the same periods in 2019. Turning now to our balance sheet and cash flow, as of September 30, 2020, Caladrius had net cash - excuse me had cash and cash equivalents of $40.3 million and working capital $37.1 million. As previously disclosed, our cash and cash equivalent position significantly improved as a result of the $10.9 million proceeds received from the sale of our qualified New Jersey NOLs as well as two registered direct offerings that raised a total of $9.3 million in gross proceeds. In July 2020, we boosted our cash and cash equivalents position even further, with the closing of a $2.0 million private placement. It is noteworthy, that the two registered direct offerings and the July private placement are all priced at the VEN market price. Lastly, the company has opportunistically raised $8.5 million through its common stock aftermarket sales agreement with H.C. Wainwright & Company year-to-date, of which $7.2 million was raised in July and August 2020. Our net cash used in operating activities of $3.3 million for the nine months ended September 30, 2020 was heavily influenced by the $10.9 million in proceeds received from the sale of our qualified New Jersey NOLs. Excluding the New Jersey NOL proceeds, we continue to manage operating burn effectively at less than $5 million per quarter on average, while continuing to advance our research and development programs. Despite the current economic environment and growing challenges, Caladrius successfully secured approximately $30 million in new capital year-to-date, one-third of which was non-dilutive, which will support the initiation and execution of two new studies in 2020, the private study of CLBS119 for the treatment and repair of COVID-19 induced lung damage, and the Phase 2b FREEDOM trial of CLBS16 in coronary microvascular dysfunction. Overall, the company remains confident that its current cash balance will fund operations through the end of 2021. That completes the financial overview and now I move on to our exciting clinical development pipeline. As I've done on previous calls, I will begin by providing a high-level summary of what we are doing at Caladrius and why we believe our development programs are an increasingly relevant and attractive investment opportunity today. Caladrius is focused on the development of cellular therapies designed to reverse disease. And we have late-stage clinical programs underway based on a large database of human clinical data. To date, our therapies have shown strong signs of effectiveness and durability with a pristine safety profile and present the possibility of substantial pharmacoeconomic benefit. Most importantly, we remain focused on the development of personalized curative cell therapy products that will restore human health and improve quality of life with a single administration of the therapy rather than one that requires chronic re-administration. Our CD34+ cell therapy technology has led to the development of therapeutic product candidates designed to address diseases and conditions caused by ischemia, a condition in which the supply of oxygenated blood to healthy tissue is restricted. Previously published preclinical and human clinical studies have demonstrated that the administration of CD34+ cells induces angiogenesis of the microvasculature, that is, that these cells prompt the development of new blood capillaries, thereby contributing to the prevention of tissue death by facilitating blood flow to the area of ischemic insult. We believe that several conditions caused by underlying ischemic injury can be improved through the application of our CD34+ cell technology, including but not limited to COVID-19 induced lung damage, critical limb ischemia or CLI, coronary microvascular dysfunction or CMD, and refractory angina. I will now speak to the specifics of each of our development programs kicking-off with HONEDRA, formally known as CLBS12, our product candidate for the treatment of critical limb ischemia in Japan. As I have described previously, CLI is characterized by severe obstruction of the arteries that significantly reduces blood flow to the lower extremities principally the feet and legs, and represents the end stage of peripheral arterial disease. CLI patients often experience severe wrist pain, limited mobility, non-healing skin ulcers and if not successfully treated, eventual amputation. Please note, that it is a well-documented but not well-known fact that CLI patients have a higher prevalence and the higher mortality rate than patients with most cancers. HONEDRA was awarded a SAKIGAKE designation from the Japanese Regulatory Authority Authorities for the treatment of CLI. The SAKIGAKE designation is akin to an RMAT designation in the United States, and affords the recipient prioritized regulatory consultation, a dedicated review system to support the development and review process including the option of a rolling registration submission, as well as reduced review time of six months for the HONEDRA registration application once filed. HONEDRA is also eligible for early conditional approval, and possibly full approval in Japan, based on the compelling nature of the complete data from an ongoing prospective, randomized controlled open label multicenter study in CLI patients in Japan. The ongoing study in Japan comprises subjects divided into two cohorts, a 30 subject group with traditional atherosclerotic no-option CLI and a 7 subject group with Buerger's disease, a type of CLI, often associated with heavy smoking and which is an orphan designation. Those subjects were allocated to treatment are dosed with our CD34 cell therapy in a single treatment through a series of intramuscular injections, in addition to receiving standard of care pharmacotherapy. Subjects randomized to the control arm only receives standard of care with drugs approved in Japan, including antiplatelet agents, anticoagulants and nasal dilators, the choice of which is made by the investigators according to the protocol. The study allows for the rescue of subjects in the control arm by indicating the cross over to treatment if that CLI deemed to be progressing. The primary objective of this study is to show that HONEDRA can prevent the serious consequences of CLI, by reverting the patient to a CLI free condition through improved blood flow in the affected limb. CLI free status is defined as two consecutive monthly visits in which rest pain is absent, and previous non healing skin ulcers are completely healed, as determined by an independent adjudication committee. As previously reported, and as you can view in our corporate presentation on our company website, the Buerger's disease cohort is completely enrolled and the results from that group are very positive and consistent with the beneficial therapeutic effect and safety profile, as reported by previously published clinical trials in Japan and the United States. For patients with Buerger's disease, amputation and even death are likely outcomes and no available pharmacotherapy prevents amputation. However, subjects in the Buerger's disease cohort in our study have achieved a remission rate of approximately 60%, meaning that four out of the seven subjects have met the primary endpoint in our CLI3, which is an outstandingly positive result for these patients, we normally see continued progression leading to amputation. We're very encouraged by study results to-date, and believe that they suggest a positive outcome for the overall trial recognizing, however, that the final conclusions of the trial will be dependent on all data from all subjects. Despite the global impact of COVID-19, enrollment in our trial is continuing, though like most companies executing clinical trials around the world, enrollment remains unpredictable in its rate and duration. However, the company remains encouraged by the patient pre-skinning profile that has been identified to complete the no-option CLI cohort, and now anticipates trial enrollment to conclude in the first quarter of 2021, leading to top line data for the full study in late 2021 or early 2022. Regarding commercialization, our strategy remains to license with partner HONEDRA in Japan. And to that end, our conversations continue with prospective partners and we continue to see the consummated deal in - the completion of the study if not before. Turning now to CLBS16, our promising CD34+ cell therapy product for the treatment of coronary microvascular dysfunction. Like all of CD34+ cell therapy product candidates, CLBS16 uses a proprietary and patented formulation of CD34+ cells specifically designed for an injection at or near the site of ischemic insult which in the case of CMD is an infusion into a coronary artery. CLBS16 is the subject of the recently completed ESCaPE-CMD trial, a 20 patient proof of concept clinical trial, evaluating CLBS16 as a treatment for coronary microvascular dysfunction, a disease involving damage to the tiny arterial blood vessels to microcirculation in the heart, with no accompanying discernible large vessel blockages. Despite the absence of large vessel disease, CMD patients have an equally poor prognosis related to major adverse cardiac events and death as to patients who have identifiable large vessel blockages. As a result, people living with CMD are often under diagnosed, misdiagnosed, and or untreated because there are no large artery blockages to visualize. This is especially important to note, that CMD is more frequently prevalent in females than males, making this an important emerging women's health care issue. CLBS16 is designed to address and reverse the underlying pathology of CMD by employing the CD34+ cell innate ability to increase microcirculation and thereby, hopefully improve the long-term outcomes and quality of life in those living with CMD. In May 2020, the company announced the full data results from the ESCaPE-CMD trial at the Society for Cardiovascular Angiography and Interventions or SCAI 2020 Scientific Sessions virtual conference. As predicted by preliminary results at the American Heart Association Scientific sessions in November 2019, data showed highly statistically significant improvements in coronary flow reserve correlating with symptom relief for patients with CMD after single intracoronary injection of CLBS16. We remain committed to raising awareness of this growing women's health crisis as we initiate the Phase 2b FREEDOM study of CLBS16, with the first patient expected to be enrolled shortly. The double-blind randomized placebo-controlled trial will evaluate the efficacy and safety of delivering autologous CD34+ cells, that is CLBS16, in subjects with CMD and without obstructive coronary artery disease. And then moving on to CLBS119, how autologous CD34+ positive cell therapy with the repair of COVID-19 induced lung damage. We believe that thousands of patients globally who survive COVID-19 suffer long-term effects of the disease manifested as debilitating lung damage. Since the rise of the pandemic, many companies have mobilized to determine effective treatments for the acute effects of the virus and or for a vaccine that torts infection all together. Caladrius on the other hand, has taken a leadership position in helping COVID-19 survive roots were still experiencing hypoxia or shortness of breath, and required supplemental oxygen. Evidence to date indicates that a large portion of COVID-19 survivors who required mentalatory [ph] support, suffer long term debilitating lung damage. COVID-19 appears to damage the vasculature of the lungs, and we believe the repair of that vasculature will prove necessary for patients to achieve a full recovery. Experience from the first source epidemic, provided well documented clinical evidence that the Coronavirus target cells that express CD34 and the resulting depletion of that cell population is thought to be connected to the lungs inability to completely repair itself. Furthermore, the COVID-19 pandemic emerging evidence indicates that the endothelial cells that line the microvasculature of the lungs are targeted by the virus, and that the destruction of the lung microcirculation may be a critical factor in the ability of the lung to auto repair even after the virus has been eliminated. Previous clinical trials and preclinical models have shown that CD34+ positive cells act in a regenerative capacity in multiple organs including models of severe lung damage. Moreover, there is evidence in preclinical models that restoring microvascular function can trigger and sustain a regenerative process in the lungs. Based on the accumulation of evidence that CD34+ cells can repair multiple organs, including models of severe lung inflammation, the company saw and received FDA authorization for its investigational new drug application for the study of CLBS119 and CD34+ cell therapy product targeting potentially permanent lung damage resulting from the COVID-19 infection. The 10 to 12 patient open label proof of concept clinical trial is designed to evaluate the safety and efficacy of a single administration of CLBS119 for the treatment and repair of COVID-19 induced lung damage in adults were still experiencing hypoxia due to prior infection and require supplemental oxygen. As previously announced, the trial was initiated last month and is actively screening patients at NYU Langone Health Center in New York City. So, in closing, we are very pleased with the corporate and develop development achievements made in the third quarter, which attest to our ability to successfully navigate the current global landscape with agility and to deliver on key strategic initiatives. Throughout the balance of the year, we expect to build on this momentum as we further advance and expands our clinical development pipeline while executing on a number of important milestones. And with that overview operator, we're now ready to take questions.

[Operator Instructions]. Our first question comes from the line of Emanuela Branchetti.

Hello, guys and thank you for taking my questions and congratulations on the progress. I have a couple of questions. Can you please remind me the design of the study of the CLBS16 study? I don't think I remember how many patients you are planning to enroll? And how long do you expect this study to take?

Certainly, Emanuela thank you for the question. And thanks for joining the call. The FREEDOM study is actually going to consist of 105 patients, and it will be broken into a series of arms. We'll be looking at of course, an intracoronary injection of CLBS16 versus placebo in that study. And we will also be testing a retrograde injection to see if we could simplify the administration of the product, as well as looking at the possibility of administration of frozen product, or rather product that has been previously frozen. So there are multiple arms there. The endpoints for the study consist of typical endpoints in an angina program, and those specific to CMD. So there'll be - all the endpoints will be looked at six months of course we'll be monitoring at other time points, but six months will be the principal time period. And we'll look at coronary flow reserve, as well as angina frequency, exercise tolerance, and a number of other quality of life questions. The trial article is on clinicaltrials.gov as well.

Got it. Thank you very much for that. And switching on to CLBS12, I was wondering if you can give us a little bit of color on whether you're having conversation with the EMA? I remember CLBS12 getting - receiving advanced therapy medicinal product designation, by the EMA. And I was wondering out of those the conversation you are having with the EMA still going on, or you are obviously waiting for the results of the study?

Well, two factors have impacted our continued dialogue with the EMA. The biggest factor, however, is the pandemic. It is virtually impossible to conceive of starting a CLBS12 program anywhere in Europe at this point in time, given the resurgence of the virus, the stress on the various healthcare systems, especially in those countries where we would likely wish to conduct the trial. We have had a number of conversations and as you correctly pointed out, we do have ATMP designation in Europe, but we're also somewhat capital constrained, and probably even without the pandemic wouldn't have started a study in Europe until the results of the Japanese trial were most likely available. However, as our capital situation continues to improve, and as hopefully the situation of the pandemic abates in Europe, we may reconsider that timing.

Sure, that makes sense. Thank you for that. Just a couple of questions on CLBS119, if I can, so you mentioned that screening is ongoing, do you think with the current COVID-19 infection rate, how do you think - how long do you think the enrollment is going to take? And maybe I don't know if you can share that. But then can you share how many patients have been screened already and perhaps have received the drug thus far, if any?

Yes, I usually don't give patient by patient updates on clinical trials. But I can tell you that the screening process has been ongoing for a while and we've been identifying patients as well as looking to open some additional sites. What is frustrating about this particular disease is its constant evolution? And so, when we conceived of this trial, and chose our initial sights for opening back in the late spring, and early summer, the New York metropolitan area was one of the hotspots in the country. And we expected to see quite a large number of patients, especially given the treatment paradigms that existed at the time for the acute treatment of the virus. Since then, a number of acute treatments have been introduced that have improved the care of the patients, and so there were fewer patients who may be remaining on ventilators or even being ventilated to begin with. And it seems that the Northeast has passed its initial surge and other parts of the country are in fact the places where the highest prevalence of the virus exists. And so we're looking to open some centers in those other places, while continuing to look for the appropriate patients here in the New York region. Our initial estimates are that it would take between three and four months to enroll the correct number of patients. And so we've - you can start counting now. And we'll, we'll see. But maybe by the end of the first quarter, we'll have some news on patients in and maybe even some early data, if things continue to go as we hope.

Sure. And related to the comments you just made about how the different drugs are affecting the course of the disease in COVID-19 patients. I was wondering if you can give us a sense of the extent of the population you can actually address given as you said the effect of other drugs and the introduction of other drugs. Do we know how many patients that suffers from severe lung damage? And how many patients are still suffering from to severe lung damage at this stage of the pandemic?

The simple answer to your question is, we don't know. And as you can see, if you look at the literature that's being published, I think that's the term that most people have agreed on for patients who continue to suffer chronic effects of the virus, even after the virus has been cleared. I think the term is called long haulers or long timers or something to that effect. But people who have had the disease, and then have recovered from the infection, but still suffer some sort of effects. I've seen estimates from tens of thousands to potentially millions of patients, who may be in that category, but I'm not sure anybody really knows. And part of the problem is it seems that, again, if you look at the literature that's being published, that a number of patients who fit that definition of long haulers are actually manifesting their chronic symptoms, several months after they have been cured of the disease, if you will. So just in the Wall Street Journal, two days ago, very large article about these kinds of patients, and they referenced patients who have the disease back in the summer, had a case that was treated, they seem to have recovered, and after the recovery, they were fine. And then two months later, they start to experience symptoms, not of the disease per se, but of long-term damage, chronic fatigue, loss of memory, shortness of breath, cardiovascular symptoms, like atria fibrillation, muscle cramps, all kinds of things. And I think this goes again, to what is evolving in the literature to be, I think, a consensus that this is a disease that affects the microvasculature of the body. But the effect in the lungs may be the first one that you see. So it's a long-winded answer Emanuela. But we're not exactly sure how many of these patients will be people who will have this long-term lung problem, but it seems like there will be people who will have long-term problems consistent with damage to their microvasculature, which should be susceptible to our cellular therapy treatment, independent of the organ impacted.

That's very helpful. Thank you for that. And I go back to the queue. Thank you.

Thank you. Thank you.

Our next question comes from the line of Kumar Raja.

Hi. Thanks for taking my question and I would like also to continue in terms of COVID-19. So, looks like side line [ph] hypoxia is a big issue with COVID-19. So, by the time these patients end up in the hospital, probably they are having some extent of lung damage. So, in that context, what are you guys thinking in terms of, how much lung damage, what levels of lung damage do you think would be optimal, before you can start the treatment with CLBS119?

Well, that's a great question Kumar, and for the specifics of the inclusion criteria on the trial, I'll refer you and everyone else to clinicaltrials.gov again, because it's, it's all there. But in the beginning, we just had to bake, basically, also make an estimate of what we thought would be a level of damage that would be measurable, and would require patients to remain on supplemental oxygen. But that would be not so I would say grave that it would be impossible to see any therapeutic effect from our drugs. And so, we define that by levels of drug oxygenation and some other criteria for the inclusion in the trial. But basically, we're looking for people who seem to have cleared the disease, who do not necessarily, hope that to do not require continued ventilatory support, but do require supplemental oxygen in order to oxygenate appropriately. And that's the class of people that we are recruiting into this particular trial.

And in terms of HONEDRA, in terms of prescreening, what are you guys able to do there, maybe any update on that, like, how that is going to impact the enrollment?

Yeah, for about six months from, say, February, or there about to the end of the summer. Our trial, as well as most other trials in Japan was effectively stalled. Patients were quarantining, they were not leaving their homes, they were not going to see a physician, or to the hospital or clinic for anything other than COVID related problems. And so, we lost a fair amount of time there. Starting at the end of the summer and into the early fall, the September months, the clinics and the physician's offices began to slowly reopen, with patients becoming more willing to venture out and go to these doctors. But the thing that is a particular frustration for us is that many of the patients who are CLI patients are also patients who have the same level of co-morbidities that would make them the most susceptible to dangerous reactions to COVID-19. So, these are the patients who are being extra careful about staying sequestered in quarantine. And so, they're taking an even longer time to venture back out. And think about joining clinical trials, we do have a good number of patients who have been identified by physicians and who are now in the prescreening process to make sure that they in fact, do qualify, and will be able to meet the requirements of all of the follow-on visits. And we hope that we'll be able to convert the requisite number of them to into actually treated patients and complete the trial. We've made some progress, we have enrolled a few more patients. In September and October, we have a handful. Again, I don't give specifics, but we have a handful of patients to go. And we are coming into the holiday - end of your holiday period. So to be conservative and also with a bit of a resurgence in other countries and perhaps in Japan as well. We're predicting that we'll complete enrollment in the first quarter of next year. And from that point forward will be just in follow up and look to report, complete data by the end of the year, early '22.

Okay, great, thanks. Thanks, Kumar.

Our next question comes from the line of Pete Enderlin.

Hello, Pete.

Yes, hi, Dave. Thanks for taking the questions. On the 119 trial, just to clarify that were those people mostly be outpatients or were those be some that are still in and while you like going on any other site that you open up?

It can be either. It can be either. The point is that they at one point had to have been on a ventilator, they required ventilator support. And then they got off the ventilator. And they now require supplemental oxygen. Some, they remain in the hospital, and some maybe outpatients. But, it's really the question of requiring supplemental oxygen that is the principal criteria for enrollment.

Right. And then, separate subject entirely. Where do you stand on the new CFO?

We're actually recruiting. We've actually - We've had in-house, a highly qualified public company CFO consultant, who's kind of helping work with us on a number of items. But I will say that our internal accounting team, and including our Vice President of Financial Operations and Treasury, James Nisco is extraordinarily competent. And he has all of the accounting, reporting and financial aspects of the business well at hand. We are recruiting for a new CFO. This is a difficult time of year to recruit, because as we get into the holidays, people are less available. And also, I'll be candid with everyone on the phone. I'm still not entirely comfortable with hiring an executive into the company based solely on video interviews, which is all we can do right now. So I'd like to meet people and spend some time with them and get to know them. And it's a little hard for me to do that in two dimensions. So, we are well covered and it may take a little bit more time to find just the right person to take that role.

Okay, and then maybe tangentially related to that. What can you tell us about the funding status for CLBS14, other than that you won't do anything until you get it?

Right well, thank you for reminding us because that is, in fact, the situation I mean, what I will say is this, that this is not just a program that's just stalled, and we're waiting for somebody to pistol a grant on us or more for us to win the lottery. In fact, we have a very active dialogue ongoing with FDA at a variety of levels that we believe, once concluded, could have a material impact on the size and the scope, and therefore the cost and timing of the Phase 3 trial. So while the current agreement, if you will, based on FDA's last position, is such that we would probably need about $70 million, and about 39 months from first patient in to top line data. We think that there's an opportunity to reduce that, perhaps significantly. And we're going to complete those discussions with FDA before we go back to active and I would say focused fundraising for that program, because it certainly will be a lot easier to raise money that would be smaller in size. And for a study that will be shorter in duration. And that's what we hope to be able to achieve. Stay tuned as we continue our dialogue.

Okay, and very interesting, but can you give us any idea of how soon you may complete those discussions with the FDA?

I have absolutely no idea. And that is simply because CBER, if you've had the opportunity, I suggest, you can do a quick search on the search engine of your choice for Peter Marks, who is one of the Division Directors at CBER, the Center for Biologics, which is the center that reviews all of our application. At almost every conference presentation he's given lately, he's been very clear in reiterating the shortage of help that they have, the lack of resources and so on at CBER. So everything is taking much, much longer. And of course COVID-19 hasn't helped. They've had to give priority to a lot of things associated with COVID-19. So as a result, things that might have taken only a month or two under normal times are taking extended periods without any real ability to predict how long they will go. I will say this, we've been having these discussions for the better part of the year. And we're encouraged that we've had some recent feedback. So it means that at least somebody is looking at our stuff and hopefully we can drive with the inclusion. But I'd be deceiving everyone if I gave an estimate of when I thought this would all be done.

Okay. And then just one last one, $40 million in cash right now, good for five quarters, or obviously $8 million per quarter. But you're running about $5 million, so can you give any sort of like a shape of how that increases and due to which specific trials ramping up?

Sure, I mean, it's the FREEDOM trial, that's the name now that's been assigned to the CLBS16 Phase 2 trial, that's 105 patients trial. We're averaging less than $5 million a quarter right now, but the only active clinical trials are 119, which just started and we're finishing up the HONEDRA trial in Japan. We'll be enrolling patients at a very active clip in that 16 FREEDOM trial, starting very soon and, by the first and second quarter of next year, that'll be at, full pace, enrolling patients. And so, that's when the R&D budget will increase directly in line with the fact that we'll have many centers open and many patients being enrolled in order to complete that trial so going course of the next year or so.

So that would be running at that point and close to $10 million per quarter in total?

I don't have those numbers directly in front of me. I mean, what you can imagine though is that, there'll be a ramp up, there might be a slight ramp up in the fourth quarter of 2020. Because we do have some sites open already. And we'll be treating patients shortly. And then that will increase substantially for the first, second, or third quarters. And then finally, as we get toward the end of the year, most of the treatment we hope as long as COVID-19 does impact enrollment estimates will have been completed. And the study will be transitioning into the follow-up and endpoint section of this trial, which is less expensive. So I guess you can expect to no significant increase in quarterly expense for a second, perhaps third quarters of next year.

Okay. That's very helpful. Thanks a lot, Dave.

All right. Thanks, Pete.

And this concludes the question-and-answer portion of the presentation. And I will now turn the call back to Dr. Mazzo for closing remarks.

Thank you, operator. Again, thank you all for participating on today's call. We look forward to speaking with you again during our next quarterly conference call, and to continuing to provide updates on our achievements and progress and we remain grateful for your continued interest in and support of Caladrius Biosciences. Please stay safe. Stay well, and have a good evening. Thank you and goodbye.

Thank you, ladies and gentlemen. This does conclude today's conference call. You may now disconnect.