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Edited Transcript of CLBS earnings conference call or presentation 5-Mar-20 9:30pm GMT

Q4 2019 Caladrius Biosciences Inc Earnings Call

New York Mar 26, 2020 (Thomson StreetEvents) -- Edited Transcript of Caladrius Biosciences Inc earnings conference call or presentation Thursday, March 5, 2020 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* David J. Mazzo

Caladrius Biosciences, Inc. - President, CEO & Director

* John D. Menditto

Caladrius Biosciences, Inc. - VP of IR & Corporate Communications

* Joseph Talamo

Caladrius Biosciences, Inc. - CFO & Senior VP

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Conference Call Participants

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* Jason Howard Kolbert

Dawson James Securities, Inc., Research Division - Director of Research

* Joseph Pantginis

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Peter Enderlin

MAZ Capital Advisors, LLC - Portfolio Manager

* Stephen Gilbertpaul Brozak

WBB Securities, LLC, Research Division - Senior Equity Analyst

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Presentation

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Operator [1]

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Welcome to the Caladrius Bioscience Fourth Quarter and Full Year 2019 Financial Results and Business Update Conference call. (Operator Instructions) As a reminder, this call is being recorded today, Thursday, March 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.

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John D. Menditto, Caladrius Biosciences, Inc. - VP of IR & Corporate Communications [2]

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Good afternoon and thank you all for participating in today's call. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer; and Joseph Talamo, Chief Financial Officer.

Earlier today, we issued a news release announcing our 2019 fourth quarter and full year financial results. 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, March 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.

With that said, I will now turn the call over to Dr. David Mazzo. Dave?

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [3]

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Thank you, John, and good afternoon, everyone. Thank you for joining us on today's call. For those of you who have been following the company closely, you will know that 2019 was an eventful and productive year for Caladrius. While carefully managing our finances, we continue to advance our proprietary CD34-positive cell therapy development programs, specifically CLBS12 as a treatment for critical limb ischemia or CLI in Japan, CLBS16 for the treatment of coronary microvascular dysfunction or CMD and CLBS14 for the treatment of no-option refractory disabling angina or NORDA.

During today's call, I will summarize our overall progress, provide additional insight into our ongoing and planned trials and discuss some upcoming milestones. But before I do, I'll turn the call over to our CFO, Joe Talamo, for his review and commentary on our financial results. Joe?

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Joseph Talamo, Caladrius Biosciences, Inc. - CFO & Senior VP [4]

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Thanks, Steve, and good afternoon, everyone. I am pleased to provide a review of our 2019 fourth quarter and full year financial results, which focus on the advancement of our ischemic repair platform.

Overall, our net losses were $5 million and $19.4 million for the 2019 fourth quarter and full year periods compared with net losses of $3.6 million and $16.2 million for the 2018 fourth quarter and full year periods. The increases in net losses were related entirely to increased research and development efforts in 2019, which resulted in the advancement of our programs. Research and development expenses for the 2019 fourth quarter and the full year periods were $2.8 million and $10.8 million, representing increases of 84% and 42%, respectively, over the prior year periods.

In our ongoing study of CLBS12 in critical limb ischemia in Japan, we continue to focus spending on patient enrollment to complete this study in the first half of 2020. As we've indicated previously, we project that our existing cash balances are sufficient to cover the completion of enrollment and the projected 12-month follow-up on the last patient treated.

In our ESCaPE-CMD study, we completed enrollment in May 2019, and together with an NIH grant supporting the vast majority of the cost of this program, we have to date funded substantially all study-related costs, with minor additional costs expected in early 2020 to complete analysis of the full data set. We expect to announce the final result soon. And in a moment, Dave will discuss the next steps in this program.

Lastly, throughout most of 2019, we were focused on the preparation and the initiation of the CLBS14 Phase III NORDA clinical trial and have reached a point of readiness to commence the trial. However, as we discussed during the third quarter conference call in November, we have projected that this Phase III study would cost approximately $70 million in external expenses over the next several years to complete. As a result, we elected to postpone the initiation of this study until we have confidence that we can access sufficient capital to fund this study uninterrupted to completion.

Moving to G&A. Our expenses for the 2019 fourth quarter and full year were approximately $2.3 million and $9.3 million, which were relatively unchanged compared to the prior year periods in 2018. G&A expenses are focused on general corporate-related activities.

Turning now to our balance sheet and cash flow. As of December 31, 2019, we had cash, cash equivalents and marketable securities of $25.2 million with a working capital of $20 million, and then operating activities cash burn of under $19 million for 2019 or less than $5 million per quarter. Based on existing programs and projections, we remain confident that our cash on hand will fund our operating plan through the second quarter of 2021. We will continue to seek additional capital from all possible sources in the near term and extend -- to extend our cash runway and to fund our near-term operating plans.

With that, let me turn the call back to Dave.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [5]

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Thanks, Joe. I will begin by reiterating my comments from our last call and provide a high level description of what we are doing at Caladrius and why our development programs are increasingly relevant and attractive investment opportunities today.

As many of you may be aware, the majority of companies in the cell and gene therapy space are focused on treating cancers and/or rare diseases. Though there's clearly a need for advances in these areas, heart disease continues to be overlooked despite being the leading cause of death in the United States and most of the developed world. One of the factors that differentiate Caladrius from other biopharmaceutical companies is that we are focused on developing cell therapies that reverse, as opposed to manage, cardiovascular diseases, and we have late-stage clinical programs underway with a large database of human clinical data.

Our therapies to date have been shown to be well tolerated, effective, durable, economical and pharmacoeconomically justified. Most importantly, we are working on products with the goal of providing patients with a single administration curative therapy, rather than one that requires chronic readministration.

With that said, let me provide a summary of the basis for our CD34-positive cell therapy platform. Our CD34-positive cell 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 animal and human studies have demonstrated that the administration of CD34-positive 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 several conditions caused by underlying ischemic injury can be improved through the application of our CD34-positive cell technology, including, but not limited to, critical limb ischemia, coronary microvascular dysfunction and refractory angina.

Now I'll speak to the specifics of our CD34-positive technology-based clinical programs, beginning with our product nearest to commercialization, CLBS12 in Japan. Among others, our CD34-positive cell technology has spawned the development of our product candidate for the treatment of critical limb ischemia, CLBS12, which is currently in an ongoing, registration-eligible clinical study in Japan. CLI is characterized by a 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 rest pain, limited mobility, non-healing skin ulcers and, if not successfully treated, eventual amputation. Please note that it is well documented, but not well-known, that CLI patients have a higher mortality rate than patients with most cancers.

CLBS12 was awarded a SAKIGAKE designation from the Japan Ministry of Health, Labor and Welfare for the treatment of CLI. The SAKIGAKE designation is a regulatory designation 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 as well as reduced time of 6 months for the CLBS12 registration application once filed.

CLBS12 is also eligible for early conditional approval and possibly full approval based on the compelling nature of the complete data from our ongoing prospective, randomized, controlled, open-label, multicenter study in CLI patients in Japan.

In addition, European Medicines Agency granted CLBS12's advanced therapy medicinal product, or ATMP classification, for the treatment of CLI. ATMPs are defined as medical treatments that are based on genes or cells and are intended as long-term or permanent therapeutic solutions to acute or chronic human diseases at a genetic cellular or tissue level. This regulatory achievement sets the stage for us to work closely with European regulators to define the most expeditious path and regulatory plan to registration for CLBS12 in the EU.

The ongoing study in Japan comprises subjects divided into 2 cohorts, a 30-subject group with traditional arterial sclerotic CLI; and a 7 subjects group with Buerger's disease, a type of CLI often associated with heavy smoking. Those subjects who are randomized to treatment are dosed with CLBS12 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 received standard of care with drugs approved in Japan, including anti-platelet agents, anticoagulants and vasodilators, 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 crossover to treatment if their CLI is deemed to be progressing.

The primary objective of this study is to show that CLBS12 can prevent the serious consequences of CLI by reverting the patients to a CLI-free condition through improved blood flow in the afflicted limb. CLI-free status is defined as 2 consecutive monthly visits in which rest pain is absent and previous nonhealing skin ulcers are completely healed, as determined by an independent adjudication committee.

As previously reported, and as you can review in our corporate presentation on our company website, the responses observed to date in the Buerger's disease cohort are very positive and consistent with the beneficial therapeutic effect and safety profile, as previously reported in 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 pharmacotherapies prevent amputation. However, subjects in the fully enrolled Buerger's disease cohort in our study have achieved the remarkable remission rate of 57%, meaning that 4 of 7 subjects have now met the primary end point and are CLI-free.

It is worth repeating that the natural history of Buerger's disease patients is continued disease progression leading to likely amputation. So our data are extraordinarily positive. We are very encouraged by the 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.

We continue to anticipate complete enrollment in the study during the first half of this year, with top line data for the full study in early 2021 leading to an earliest possible approval in Japan in late 2021 or early 2022. That said, it is too early to tell if the recent outbreak of COVID-19 coronavirus in Japan will have a negative impact on enrollment rate for the remaining subjects needed to complete the trial.

Regarding commercialization, our strategy remains to license our partner CLBS12 in Japan. And to that end, our conversations continue with prospective partners, and we continue to seek to consummate a deal in concert with the completion of the study, if not before.

Turning now to CLBS16, our promising CD34 product candidate for the treatment of coronary microvascular dysfunction. Like all our CD34-positive cell therapy product candidates, CLBS16 uses a proprietary and patented formulation of CD34-positive 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 plaqueless heart disease and involving damage to the interlining of the tiny arterial blood vessels in the heart with no 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. But because obvious large artery blockages aren't seen, CMD is often underdiagnosed, misdiagnosed or untreated. It should also be noted that CMD is more frequently encountered in females, making this an emerging -- excuse me, an important emerging women's health care issue. CLBS16 is designed to address the symptoms and physiology of CMD by employing the CMD -- CD34-positive cells' innate ability to increase microcirculation.

In November 2019, at the American Heart Association scientific sessions, we reported the data for those patients, that is 17 of 20, who at the time had completed their 6-month follow-up visit in our ESCaPE-CMD trial. The data showed highly, statistically significant improvement in coronary flow reserve correlating with symptom relief for patients with CMD after a single administration of CLBS16. The results of the ESCaPE-CMD trial are not only important for defining the next development step for CLBS16, but they provide the first direct quantitative evidence in humans, corroborating the mechanism of action of CD34 cells, something which is supportive of all of our programs.

The initial results were outstanding, and we look forward to reporting complete results in the first half of 2020, the timing of which is dependent upon acceptance for publication or presentation of the complete data set in the scientific journal or at a noteworthy scientific conference.

We are planning to advance the CLBS16 program to its next clinical development step, a Phase IIb study, as expeditiously as possible, with a target for first in-patient sometime around midyear.

And now moving on to our Phase III-ready CD34 cell therapy product candidate in the United States, CLBS14. CLBS14 is being developed to address no-option refractory disabling angina, or NORDA, by stimulating the growth of new microvasculature in an oxygen-deprived heart and those patients who have had large vessel disease treated with all available therapies but still have debilitating angina, likely due to microvasculature deficiency. Our confidence in this program is based on a series of published Phase I, II and III study results that indicate a consistency of therapeutic effect of CD34-positive cells to increase exercise tolerance, improve heart function and decrease long-term mortality associated with the condition.

As discussed on our last quarterly call, we finalized with FDA the protocol design for a confirmatory Phase III trial to support the registration of CLBS14 for NORDA in the U.S. But due to the projected cost of the study, we have deferred its initiation in the U.S. pending confidence that would require sufficient capital to fund the study to completion. Among the possible sources of capital are non-dilutive grants and/or partnerships, both of which we are pursuing vigorously.

So in closing, we are very pleased with the corporate development achievements made throughout 2019 and believe that these accomplishments form the foundation from which we expect to attain a number of key milestones throughout 2020. Our experienced, dedicated and passionate team remains committed to the efficient and effective advancement of our programs as we work to bring innovative treatment options to patients in need and restore human health.

And with that overview, operator, we're ready to now take questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from the line of Joe Pantginis with H.C. Wainwright.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]

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Curious, while you're executing the study in CLI in Japan, what kind of background activities are you doing that might help drive a partnership with regard to, say, market research or pharmacoeconomic data, et cetera? I'm just curious what kind of background activities. And then separately, with regard to the NORDA plan, it's great you have the FDA sign off, if you will, on the protocol. Just curious if anything else is outstanding that needs to be answered, that a partner might want to see.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [3]

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Thanks, Joe, and thanks for joining us this afternoon for those questions. I'll take them in the order that you asked. So first, as it relates to CLBS12, in fact, we've completed almost all of the background -- actually, not almost, all of the background information necessary to contribute to partnership discussions. We have a complete pharmacoeconomic analysis and an incidence and prevalence analysis in Japan, along with a competitive product analysis that I think is very positively disposed toward our product. Conversations with a variety of companies, all of them Japanese companies, large and small, are focused on the partnering of CLBS12 and its eventual commercialization in Japan continue to progress. And I think, really, the only outstanding factor could be the completion of the trial and the final outcome.

But as I mentioned in my prepared remarks, all of the data to date for those patients who have completed their follow-up is highly corroborative of previously reported data, and we believe that the trial remains on track to have a high probability for clinical success and, therefore, eventually, a successful partnership.

As it relates to NORDA, we really don't have anything else outstanding with partnership requirements there. We have a finalized protocol with FDA. We have a manufacturing facility that has been identified, that has qualified, not only for Phase III but it's qualified to produce commercial product. We have investigators lined up, got IRBs put together. In short, we are completely Phase III-ready to initiate. The only remaining outstanding factor is the securing of the capital, as I mentioned, and we're working diligently to do that. And that likely could come from a partnership as well as some contributions from grants and other sources of non-dilutive funding. And we continue to pursue partnership discussions vigorously in that regard.

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Operator [4]

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Your next question comes from the line of Jason Kolbert with Dawson James.

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [5]

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Two quick questions. I know at AHA, your reported data on 17 to 20 patients. And David, I heard you've mentioned that you'll have the complete data set first half '20. I just wondered, is -- any insights into differences that we might see? Because I believe you did report a p-value in that -- the AHA, 0.0087. I just wanted to just get a feel for what we might expect there? And I have a follow-up.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [6]

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Sure. Thanks, Jason. Appreciate you being on the call and asking the question. So to be very clear, we actually have the complete data set in hand, and the reason we haven't released the information publicly yet is we have submitted that information as part of a publication and presentation application to a variety of respected -- well, to some respected journals as well as a respected cardiovascular conference. And in order to get those things accepted, we can't release the information up ahead of time.

But I can tell you that there really will be no surprises when the complete data set is released. You will find that is completely consistent with the information that was presented for the 17 patients that had completed follow-up at the time of the AHA meeting. And in all other factors that we've looked into remain in line with the kind of results that we saw for the symptomatic scores that we reported at AHA.

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [7]

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And I just want to follow up on something that Joe Pantginis said, which is the market size for CLI in Japan. I know -- you know that I lived in Japan about 100 years ago. And back then, the incidence of heart failure in Japan was much lower than it was in the Western world. I think that that's actually changed a lot. So I guess what I'm really asking is outside -- and I know there is a lot of smoking in Japan. So just help us understand what kind of market size you might be looking at?

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [8]

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All right. So the market research we've done, which is based both on qualitative and quantitative inquiries specifically done in Japan, indicates that the CLI market for no-option patients as well as Buerger's disease patients could peak in as much as $200 million a year at peak sales. And so it's a several hundred million dollar market, which is substantial for a company of our size and one that we think is very attractive. It also is -- represents probably a fraction of what the market sizes would be in the United States and in Europe, partly because even though prevalence might be slightly lower in those 2 latter areas, the absolute population numbers are bigger, and also pricing is probably going to be slightly higher in those areas than it would be in Japan.

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [9]

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Yes. That's very consistent with my understanding. And my last question is just for Joe. Joe, you mentioned that you were -- you have capital, you have runway through the next year-plus. And -- but you made a comment that you'd be looking to take capital, kind of what -- you almost said it, capital at any terms. And I just want to hear you say that you're looking for opportunities to take non-dilutive capital and that you're going to be very careful about what kind of capital you take.

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Joseph Talamo, Caladrius Biosciences, Inc. - CFO & Senior VP [10]

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Yes and -- how are you doing, Jason? That's correct. We're -- we have a cash runway, existing cash on hand through the second quarter of 2021. And we will look to all capital opportunities, including non-dilutive, and we'll pursue those very vigorously. And from a capital acquisition standpoint, we're not going to look to take any terms. We'll be very selective in what we're doing because we have the benefit of over a year's worth of cash on our balance sheet.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [11]

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Yes. And I'll add, Jason, simply that the reason that we'd be looking to take on additional capital now is simply to accelerate some of the work that we're doing on our programs, or perhaps add some new things that could provide additional opportunities for value creation for shareholders.

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Operator [12]

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Your next question comes from the line of Steve Brozak with WBB.

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Stephen Gilbertpaul Brozak, WBB Securities, LLC, Research Division - Senior Equity Analyst [13]

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Quick question because there's -- you're looking at the strength and conviction of everything that you're doing in Japanese operations and how you're seeing a lot of reinforced behavior. Can you tell us why the U.S. is much less so especially given the strength of the data, the strength of how you plan for trials and what you've seen, as far as outcomes go? And obviously, the need for new therapies, new courses of therapies. And one follow-up after that, please.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [14]

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Sure. So it's just a timely question. It's a subject that we debate regularly internally. And I was actually on the phone today with a close friend and colleague at a very large venture capital firm, kind of just talking about things generally. And the feeling is that -- and I'm speaking now sort of speculatively, but as it relates to us, and this is based a little bit on the feedback we get on the road, too. The field of cardiovascular medicine, in general, is one where investors have become a bit gun-shy because the knee-jerk reaction to proposals for development programs in cardiovascular medicine is that they are highly expensive and highly uncertain because you're looking for issues that could be resulting in unforeseen safety issues, et cetera. And so there's a great deal of reticent to invest in cardiovascular medicine, simply because they see the return on investment in, say, oncology as being something that's more forgiving.

Now that said, there is a clear recognition that as we provide more data and more assurances that, a, there are no safety concerns, and, b, that efficacy is really reproducible that the market will come around. And so it's a hard thing for us to accept and for our shareholders to accept. But I think it's just simply a matter of time as we continue to generate data, CLI data out of Japan and now the CMD program, which is showing fantastically positive data. I think eventually, people will not be able to ignore it any longer.

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Stephen Gilbertpaul Brozak, WBB Securities, LLC, Research Division - Senior Equity Analyst [15]

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Okay. And the follow up actually does pertain -- given that you guys have executed in the past, obviously, you are able to, I guess, to sell the PCT assets for multiples of your entire market cap. And looking at -- how should we understand what the value proposition is for Caladrius today? Because it was a matter of record that you -- Hitachi paid out multiples of what your entire franchise was trading for at the end of the day. So how should we look at -- how do you consider the value proposition for Caladrius today? And I'll hop back in the queue.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [16]

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Thank you, Steve. Yes. I mean the way we look at it is as follows. If you simply look at the market projections for the indications in which we are working and the competitive landscape, you see that for NORDA, for example, the -- there really are no -- as the name implies, there are no available therapies that provide any real relief for these patients, and we have what could be a curative therapy. So even based upon modest price projections for a regenerative -- a curative, regenerative therapy, you're looking at the opportunity to take a substantial, if not the entire, market share in that indication, and that could easily lead to billions of dollars of peak sales for that indication alone. For the market prevalence there, it's where the market opportunity is large, billions of dollars.

The same holds true for CMD, where the prevalence is even greater and where the disease has not really even been treated because it has been for so long misdiagnosed or underdiagnosed. So another, very large market opportunity with no competition on the horizon. And then we just already discussed CLI and its market opportunity.

What's important is that some of the things that make people concerned about cardiovascular medicine, especially the risk when you're sort of tinkering with the heart or with the cardiovascular system, is not something that we think really pertains to our therapies. We have never, in any of our studies or in any studies done with CD34 therapies by other collaborators, has there ever been a reported adverse event associated with the cells. So the -- as you would expect with an autologous cell therapy, highly, highly well tolerated. Highly, highly safe. So that's one way to look at it. You've got enormous, untapped market opportunities, high unmet medical need and a pharmacoeconomic case for a curative therapy to be reimbursed.

The other way to look at it would be, consider Caladrius, much like a closely held private company. Even though we're public, you can see we have a lower trading volume, because most of our shareholders are holding, they don't want to sell. And if you looked at comparable private companies, comparable in the sense of available cash, cash runway, cash burn and then extent of development, stage of development of their programs, number of programs and the ability to get to milestones, I think you would find that the typical comp would probably have a market cap 8 to 10x where our market cap is today. So by all accounts, however you look at it, we believe that Caladrius is -- has an enormous upside potential based into its stock. And that's how we would suggest our investors consider it.

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Operator [17]

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Your next question comes from the line of Pete Enderlin with MAZ Partners.

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Peter Enderlin, MAZ Capital Advisors, LLC - Portfolio Manager [18]

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First one, just in the press release, the wording says, "awaiting finalization of a funding plan for NORDA before commencing the trial." That sounds pretty imminent if you just read the plain words there.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [19]

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No, it's not meant to suggest timing whatsoever. It's meant to be literally interpreted. It means -- it's just -- it's another way of saying what we've been saying all along without sounding overly repetitive. We don't intend to start the trial until we are confident that we have sufficient funding to conduct the entire trial uninterrupted. And that's something that we don't have today, but are something on -- that -- on which we're working on getting.

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Peter Enderlin, MAZ Capital Advisors, LLC - Portfolio Manager [20]

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Right. Well, Dave, would you say that it's more likely to be dilutive or non-dilutive at this point as you work with...

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [21]

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Can't really say. I would think that -- it's really impossible for me to say, although I would suspect that it's -- well, let's put it this way. I'll say it in a different way, because I don't want to say what's more likely. Our preference and our focus is on a partnering approach to funding which, by definition, is non-dilutive. But that's not exclusive.

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Peter Enderlin, MAZ Capital Advisors, LLC - Portfolio Manager [22]

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Sure. Okay. And then relating to pricing, I mean I know that in some sense, it's premature to ask about that. But I'm sure in your long-term plan, you think about those things a lot. But the specific question I have is, as you think ahead, and recognizing that all of these are onetime administrations and they're all fairly expensive. I mean it depends what your perspective is and there are drugs cost couple of million dollars. But taking the Bluebird example for one, they have this product called Zynteglo, which is a onetime thing. It cost $1.8 million, I think. But their plan is to have an upfront payment, I think it's like 1/5 of the total, and then 4 equal payments over 5 years contingent on the patients, actually contingent with the benefit, in that case from thalassemia indication. So would you guys consider something like that as a possible funding mechanism for patients? Because there are a lot of people that say, a $30,000, $50,000, $80,000, whatever, $100,000 program is still very expensive.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [23]

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I would say that it is premature to discuss pricing specifics. But I can provide some ideas and guidances. So first and foremost, we've said multiple times publicly that the costs associated with our programs are at least 1 order of magnitude and potentially 2 orders of magnitude lower than things like the CAR-Ts and some of the products that you've cited. So one would expect that the ultimate commercial price would reflect a similar discount in comparison to those programs. A simple way of saying it, we don't expect to be charging $1 million for any of these onetime therapies because we want them to be applied widely, and they will be applied more widely under those cases. And we still believe that we'll achieve the goal of being properly rewarded financially, as with our shareholders, for completing the development and providing this therapy to patients and allowing for the widest dissemination of the activity. So we don't -- no one should count on pricing estimates for our products in the millions of dollars. That's not what's going to be the case.

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Peter Enderlin, MAZ Capital Advisors, LLC - Portfolio Manager [24]

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Right. Well, you've said before that some of these could be priced an order of magnitude lower than some of the other cell therapies. Now you just mentioned 1 or 2 orders of magnitude. 2 orders of magnitude means, I think, if I remember my math correctly, 1/100 of the price or the magnitude of something else. Is that literally what you could be talking about here? It's something that cheap?

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [25]

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Yes, in the tens to hundreds of thousands of dollars as opposed to millions of dollars, yes.

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Operator [26]

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This concludes the question-and-answer portion of the presentation. I'll now turn the call back over to Dr. Mazzo for closing remarks.

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David J. Mazzo, Caladrius Biosciences, Inc. - President, CEO & Director [27]

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Thank you, everyone. I again want to thank you for participating in today's call, and we look forward to speaking with you again during our next conference call in a few months and to continuing to bring you the news of our achievements and progress. We remain grateful for your continued interest in support of Caladrius Biosciences, and we wish you a pleasant evening. Thank you and goodbye.

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Operator [28]

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Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.