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Edited Transcript of CLBS earnings conference call or presentation 9-May-19 8:30pm GMT

Q1 2019 Caladrius Biosciences Inc Earnings Call

New York May 24, 2019 (Thomson StreetEvents) -- Edited Transcript of Caladrius Biosciences Inc earnings conference call or presentation Thursday, May 9, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* David J. Mazzo

Caladrius Biosciences, Inc. - CEO, President & 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 - MD & Head of Healthcare Research

* Joseph Pantginis

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

* Keay Thomas Nakae

Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics

* 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 Biosciences First Quarter 2019 Financial Results and Business Update Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, Thursday, May 9, 2019. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communication 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 first quarter financial results. If you've not received a copy of this news release or if you would like to be added to the company's e-mail distribution list, please e-mail me at jmenditto@caladrius.com.

Before we begin, I will remind you that comments made by management during this conference call will contain forward-looking statements that are -- 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 identify 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 this live broadcast, May 9, 2019. 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'll turn the call over to Dr. Mazzo. Dave?

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

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Thank you, John. Good afternoon, everyone, and thank you for joining us. I'm pleased to welcome you to the first conference call pertaining to 2019 and to be reporting on a busy and productive quarter.

During this quarter, we made steady progress in our 3 proprietary CD34 positive cell therapy development programs, namely CLBS12 as a treatment for critical limb ischemia; CLBS14-CMD for the treatment of coronary microvascular dysfunction; and CLBS14-NORDA for the treatment of no-option refractory disabling angina.

We reiterate our current expectations to report top line results with CLBS14-CMD ESCaPE-CMD trial by the end of 2019, and for the CLBS12 CLI trial in Japan during the first half of 2020. Additionally, we are near to completion of our discussions with the U.S. Food and Drug Administration on protocol design for our CLBS14-NORDA Phase III clinical program and have targeted initiation of that Phase III study in the fall of 2019.

Before I provide more detail on our overall progress and offer additional insights into ongoing and planned trials as well as some upcoming milestones, 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, Dave, and good afternoon, everyone. I'm pleased to provide an update on our first quarter financial results highlighted by lower operating expenses and lower operating cash burn compared with the prior year period and an overall strong financial position.

Our net loss was $4.4 million for the first quarter of 2019 compared with $5 million for the first quarter of 2018, representing a 12% overall decline. R&D expenses were $2 million for the first quarter of 2019, representing a 10% decrease compared with $2.3 million for the prior year period.

Although the current year period reflected a minor decline, our spending in both periods focused on the aggressive advancement of our ischemic repair platform across 3 programs. In our Phase II study of CLBS12 in critical limb ischemia in Japan, we continued to focus spending on patient enrollment with the goal of delivering top line results in the first half of 2020.

In our ESCaPE-CMD study, together with the significant NIH grant support of this program, we funded the majority of all patient-related enrollment costs as we target top line data readout in late 2019. Lastly, we continue to incur expenses associated with the planning and initiation of a Phase III program for CLBS14-NORDA in refractory angina targeted for the fall of this year. Dave will provide more information regarding the status of this program momentarily.

G&A expenses were $2.6 million for the first quarter of 2019, representing a 12% decrease compared with $2.9 million for the prior year period. The decrease was due to lower general and administrative corporate-related activities compared with the prior year period.

Now turning to our balance sheet and cash flow. As of March 31, 2019, Caladrius had $38 million in cash and marketable securities and working capital of $35 million. We believe our current resources on hand are sufficient to fund our ongoing operations through the second quarter of 2020, which includes the completion of enrollment and data readouts for the ongoing CLBS12 and ESCaPE-CMD studies, along with the initiation of the Phase III study for CLBS14-NORDA.

As discussed on our previous call, during the first quarter, we entered into a purchase agreement for an equity line of credit with Lincoln Park Capital, under which we will have the right to sell to them up to $26 million of common stock subject to certain limitations and conditions over a 36-month term.

On commencement of the purchase agreement, we paid Lincoln Park approximately 182,000 shares of common stock as a commitment fee and Lincoln Park purchased 250,000 shares of common stock at a price of $4 per share for $1 million in gross proceeds to the company.

We have not sold any additional shares under the purchase agreement to date, nor have we sold any shares under our existing at-the-market facility with H.C. Wainwright in 2019. We believe that the purchase agreement with Lincoln Park, when used strategically and in combination with our existing ATM facility with H.C. Wainwright, will maximize our ability to raise capital given our liquidity, stock price and baby shelf constraints. If and when appropriate, we may use one or both of these facilities or seek other financing or nondilutive options to fund our clinical programs.

We will also continue to pursue additional external opportunities that align with our initiative to supplement our current R&D platform or to identify other compelling value-creating opportunities.

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

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

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Thanks, Joe. Let me begin by providing an update on our development programs based on our CD34+ cell therapy platform. To repeat my comments from previous calls, our CD34+ 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+ cells induces angiogenesis of the microvasculature, that is that these cells prompt the development of new blood capillaries, thereby contributing to the prevention of disease -- excuse me, to the prevention of tissue death by facilitating blood flow to the area of ischemic insult.

We believe that a number of conditions caused by underlying ischemic injury can be improved through the application of our CD34+ cell technology, including, but not limited to, critical limb ischemia, coronary microvascular dysfunction and refractory angina.

Among others, our CD34+ cell technology has spawned the development of CLBS12, our product candidate for critical limb ischemia. CLI is 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.

No-option CLI means that pharmacotherapy is no longer working, angioplasty, stenting and bypass surgery have failed or are not possible and that amputation of a limb or limbs may be the only remaining treatment for these patients.

CLBS12 is currently in a Phase II clinical study in Japan and has received SAKIGAKE designation from the Japan Ministry of Health, Labour and Welfare for the treatment of CLI. As a reminder, 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, as well as reduced review time from the typical 12 months down to 6 months for the CLBS12 registration application once filed.

Additionally, CLBS12 is 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 no-option CLI patients in Japan. The ongoing study comprises subjects divided into 2 cohorts, a 30-subject group with traditional arterial sclerotic CLI and a 6-subject 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 through intramuscular injection in addition to receiving standard of care pharmacotherapy. Subjects randomized to the control arm only receive standard of care with drugs approved in Japan, including antiplatelet 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 the 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 no-option CLI by reverting the patients to a CLI-free condition through improved blood flow in the affected limb. CLI-free status is defined as 2 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 reported previously and as you can review in our corporate slide deck on our company website, the initial responses observed in the fully enrolled Buerger's disease cohort are extraordinary and consistent with the positive therapeutic effect and safety profile as reported by previously published clinical trials in Japan and the United States.

In Buerger's disease, where amputation and often death are likely outcomes and where no available pharmacotherapies prevent amputation, we are thus far observing a 50% remission rate with several patients still in follow-up. It is worth repeating that the natural history of Buerger's disease patients is continued disease progression leading to likely amputation. So you can see why we are very encouraged by these early data. We believe that these results, if maintained, 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 expect to report top line data from the completed study in the first half of 2020. As to cost, we project that it will incur less than $5 million of additional expenses to finish the study. And regarding commercialization, our strategy remains to license CLBS12 for sale in the United States and Japan.

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. Finally, previously published work, including a study in United States that showed an improvement in amputation-free survival and our progress in Japan combined with a high degree of interest and enthusiasm from U.S. and European CLI experts has prompted us to consider the initiation of CLBS12 development in the United States and Europe prior to the completion of the study in Japan, dependent upon the identification of the corresponding capital necessary to fund such a study.

Moving on to our CD34 platform as a treatment for coronary microvascular dysfunction. Like all of our CD34+ cell therapy development candidates, CLBS14-CMD 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.

CLBS14-CMD is currently being studied in the ESCaPE-CMD trial, a 20-patient proof-of-concept clinical trial evaluating CLBS14-CMD as a treatment for coronary microvascular dysfunction, a plaqueless heart disease involving damage to the inner lining of the tiny arterial blood vessels in the heart with no discernible large vessel blockages.

It should be noted that CMD is more frequently encountered in females, with 65% to 75% of patients being reported to be female. Most current estimates indicate that there are potentially millions of patients suffering from CMD who have not been diagnosed or treated, making this one of the most significant but relatively unknown women's health issues.

CLBS14-CMD is designed to address the symptoms and physiology of coronary microvascular dysfunction by employing the CD34+ cells' innate ability to increase microcirculation. As we have previously communicated, most of the cost associated with the ESCaPE-CMD trial are covered by a grant from the NIH. And as such, this study also should be considered fully funded through completion.

Similar to the results of our CLI study in Japan, the preliminary data observed in the ESCaPE-CMD open-label study comprises -- comprising those subjects who have reached the 6-month follow-up visits are extremely encouraging. With about 1/3 of the patients completed, we are observing a highly statistically significant improvement in coronary flow reserve, a direct measure of cardiac muscle perfusion, along with the corresponding improvement in symptoms. Of course, the final outcome of the trial will be dependent on the 6 months data from all subjects.

The results from this trial are not only important for defining the next development step for CLBS14-CMD, 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 and especially CLBS14-NORDA. We are looking forward to reporting top line data from the completed study by the end of 2019.

And now turning to our most clinically advanced CD34+ cell therapy program, CLBS14-NORDA. CLBS14-NORDA is being developed to address no-options refractory disabling angina by stimulating the growth of new microvasculature in an oxygen-deprived heart in those patients who have had large vessel disease treated with all available therapies but still have debilitating angina.

Our enthusiasm for 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+ cells to increase exercise tolerance, improve heart function and decrease long-term mortality associated with the condition.

Since acquiring the rights to the data and regulatory filings for CLBS14-NORDA for the treatment of refractory angina, we have successfully reactivated the IND with the FDA with Caladrius as the sponsor and received regenerative medicine advanced therapy that is RMAT designation from the FDA.

The RMAT designation affords us the opportunity to work with the FDA to advance more rapidly and efficiently the development of this therapeutic candidate in an indication that currently has high morbidity and no effective treatment options.

We continue to work closely with the U.S. Food and Drug Administration on finalizing the single Phase III protocol necessary for registration of this product in the no-option refractory disabling angina indication and are near to completion of our discussions.

To date, we have agreed to a single Phase III study for registration with the primary end point of total exercise time at 6 months. And we continue to target the initiation of this Phase III study in the fall of this year. Lastly, I'll speak briefly to the top line results of our landmark Phase IIa study of CLBS03, as previously reported.

CLBS03 has been in development for several years as a possible treatment for type 1 diabetes and is based on our proprietary T-regulatory cell platform technology for immunomodulation. CLBS03 was granted fast track and orphan drug designations from the FDA for this proposed indication and was granted advanced therapeutic medicinal product classification from the European Medicines Agency.

This program is based on the use of T-regulatory cells to treat diseases caused by imbalances in an individual immune system. This novel approach seeks to restore immune balance by enhancing T-reg number and function with the aim of stabilizing disease progression.

In 2016, we commenced patient enrollment in the first of 2 cohorts in the Sanford project T-Rex Study, a Phase IIa prospective randomized placebo-controlled double-blind clinical trial to evaluate the safety and efficacy of CLBS03 in adolescents with recent onset type 1 diabetes.

On February 13, 2019, we announced top line results indicating that the therapy was well tolerated but that the study's primary end point of preservation of C-peptide at the group level had not been achieved. We have discussed that these results were disappointing but not entirely surprising, giving the heterogeneity of the type 1 diabetes patient population and of the disease itself.

And thus, in concert with our research partner, Sanford Health, and a number of key opinion leaders in the diabetes space, we are conducting a comprehensive analysis of all data from the trial, including individual patient-level data, which will culminate with the analysis of the 2-year follow-up data for all subjects in early 2020.

We remain hopeful that we will uncover results that will inform us on the appropriate next steps to take in the development of CLBS03 in this or any other indication.

And so in closing, we are pleased to share our progress this quarter and to demonstrate continued execution against our stated objectives. Our financial position remains stable. Our pipeline programs are progressing and with the addition of the NORDA program, we have multiple mid- and late-stage product candidates under evaluation.

We look forward to continued momentum in the coming months and expect to achieve the following milestones: finalization with FDA of the protocol design for the Phase III trial to support the registration of CLBS14-NORDA in the United States, initiation of a Phase III clinical trial for CLBS14-NORDA in the U.S., completion of enrollment in the ESCaPE-CMD clinical study of CLBS14-CMD in the U.S., and announcement of top line data results and completion of enrollment of our Phase II clinical trial of CLBS12 for CLI in Japan and announcement of top line data results.

Caladrius continues to make measurable progress advancing its development programs. Our experience and expert 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 now ready to take the questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And 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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I have one -- one specific question and then one question that I guess would border as a philosophical if you don't mind. The first question is, what do you feel is outstanding with regard to your FDA discussions at this point? I don't know if you can provide any color on that.

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

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I can provide just a little bit of color. There are 2 things that remain to be finalized. The statistical analysis plan, which is often something that's finalized at the latter stages of discussion. And also, we are looking to come to conclusion on the discussion about the inclusion of the standard of care arm in the design and -- as to its size and also its duration. So those things should be wrapped up, we hope, in the coming weeks and then we'll be in a position to provide detail on the complete protocol and like all of our studies, we'll eventually publish the protocol to clinicaltrials.gov.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [4]

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Got it. No, that's very helpful. And then the -- just like I said, philosophical question is, when you look at the investment case here, you've really -- it appears that all programs remain on track. You've been hitting your milestones as you promised. There's a growing database by others and also what you've been generating in your studies, especially with your recent anecdotal data. So I guess, the question that I have here is what am I missing with regard to the disconnect in the shares, especially since you're trading below cash at this point?

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

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That's -- that really is a great question and also a, I guess, somewhat philosophical question. But you're right, we're trading at 80% of cash, and I'm going to use some, I guess, very plain talk here. But from our perspective, that is completely frustrating and frankly, stupid. The bottom line here, as you pointed out, is that the company has the strongest fundamentals that it's ever had that we have late-stage clinical programs, we have a cash balance that's projected to cover our operations for the next 15-or-so months. We have data that's coming out that portends what we believe will be positive results and that will be corroborative of all the previously published results and programs, for which there is little to no competition.

So I think there -- the real problem here is a disconnect between the outside world and our company and its performance. The fact is that many of our shareholders are shareholders. There's not a lot of trading done in Caladrius stock. We don't have a lot of liquidity because most of our major shareholders are committed to us and are not looking to trade their shares. And as a result, a small trade on a given day can make the market in Caladrius stock. And as people try to sell off small numbers of shares for whatever reason, there may not be an obvious group of buyers, and so the price tends to get depressed before that trade happens and that sets the market for the day.

The fact is that we haven't done an underwritten raise in several years, and so our institutional following is relatively small at the moment. And in the long run, that is something that we will be looking to change. But I would encourage all of the people on the line and all of the people that listen to this on webcast or read this transcript to think very carefully about the investment opportunities here because the value proposition I would propose is quite substantial, and I think if we were compared to a company who was not public, for example, a private company in our situation, with the kind of attributes that we have, you would probably see a market capitalization or a valuation that would be several-fold larger than where we are today. And so maybe even as much as tenfold.

So I thank you for asking the question and giving me the opportunity to address that. We are a strong company and a company where value proposition, I believe, is very high and opportunity is eventually going to catch up with reality. And I think we'll see an uptick as data comes out from all of our ongoing trials.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [6]

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Do you actually just -- that was a perfect point you just made right there and I really appreciate that color, I mean -- with the low volume being a major driver of the share performance on a daily basis, hopefully, the upcoming data catalysts should make that a moot point.

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Operator [7]

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And your next question comes from the line of Steve Brozak with WBB securities.

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Stephen Gilbertpaul Brozak, WBB Securities, LLC, Research Division - Senior Equity Analyst [8]

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There is one item here that I'm actually kind of curious about because you have several programs that are running right now, but they all seem to be intertwined in multiple ways. Can you give as much color as you can on the leverage between the different programs, what you can learn, what you can benefit and obviously, where you can apply lessons learned, technology and everything else at the same time? And I'd also like to follow up quickly with the leverage that you use in terms of paying for these programs with the nondilutive funding that you've been able to enjoy in the past. And that really is what I really want to know much more about, please.

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David J. Mazzo, Caladrius Biosciences, Inc. - CEO, President & Director [9]

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Sure, Steve. So I think you've underscored something that is very helpful and also should be accretive to any analysis of the -- of our company and its prospects. All of our CD34 programs are based on exactly the same technology prepared in exactly the same way using the same process, the same controls and, therefore, the same quality. The only difference among the 3 products arises from the formulation and how it is prepared for injection. So as we said multiple times, the CLI program is administered through intramuscular injections. The CMD program is administered through intracoronary injections and the NORDA program is administered through intramyocardial injections.

Now intracoronary, intramyocardial, both go to the heart. But in one case, it goes into a coronary artery and in the other case, it goes directly into the heart muscle using a mapping catheter. The fact of the matter is, though, that the mechanism of action in all these indication is the same. We're using the cells to do exactly what nature intended them to do, to promote angiogenesis, to grow capillaries and reperfuse a dying tissue. And I think what's important is that the CLBS14-CMD program uses as a primary end point the measure of coronary flow reserve, which is an actual quantitative and intrusive measurement of heart perfusion. And so this will be the first time in humans that we'll actually be able to demonstrate that the clinical symptoms that have been improved have been improved because we've actually increased blood flow into the heart. And that will be the same mechanism of action that will be driving the NORDA program. And so results from one will be highly corroborative of the other.

Similarly, we have had the opportunity to use laser Doppler imaging of the leg to show how blood perfusion increases in CLI after the treatment with CD34 cells. And we can show a foot or a limb that's stone-cold and on its way to dying and tissue necrosis become warm and reperfused and without pain and without ulcers in as many -- and as few as a couple of months after a single treatment of these cells. And so again, mechanistically, this all ties together and from a product manufacturing and control perspective, it all ties together very well. So each program supports the other in that way.

As to the nondilutive funding, we've been very successful, and I think that also points to 2 things: the quality of the science and the data that's been generated corroborating our programs to date and also the quality of our staff and their ability to adequately describe what we're doing and define new programs that are considered important in the medical community. And as a result of that, we've collected data -- collected nondilutive grant money in substantial sums from the likes of the California Institute for Regenerative Medicine, the National Institutes of Health, the Juvenile Diabetes Research Foundation and several others. And we hope that we'll be able to continue to do that to support our future endeavors.

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Operator [10]

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And your next question comes from the line of Jason Kolbert will Dawson James.

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - MD & Head of Healthcare Research [11]

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Can you talk a little bit about Buerger's disease and what the market opportunity is there? Because it's different than critical limb ischemia, although related. And so if you could give us some color about what that means and the implications given the fact that this is based in Japan but it has implications beyond Japan.

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David J. Mazzo, Caladrius Biosciences, Inc. - CEO, President & Director [12]

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Sure. Thank you, yes. So the Buerger's disease cohort -- Buerger's disease is an orphan indication and in the United States, may be considered an ultra-orphan indication. It's a genetic form of CLI that's exacerbated by the use of tobacco. And in Asian countries where tobacco use is still relatively prevalent, there is still a cohort of patients that are readily identified and as we pointed out several times over the last several calls, much to our surprise, the Buerger's cohort enrolled the fastest and completely. In fact, it overenrolled by 1. We looked for 5, we got 6 patients. In the United States, it would enroll much more slowly because it's almost a nonexistent condition. But in other countries where smoking is prevalent, parts of Europe, the Middle East, et cetera, it still remains a disease to be treated. It's a disease with a horrible prognosis, as I mentioned during the call.

So in Japan, the market opportunity for the CLI product overall, including Buerger's disease, is probably several hundred million dollars with, I would say, a relatively small fraction of that being directly related to the Buerger's. But what's important about the Buerger's cohort is it provides yet another path because of its orphan status to accelerate even further potentially the approval of an indication and the introduction of the product as a commercial entity. So as it relates to Japan and the rest of the world, the results from the Buerger's cohort may not have as much commercial import as they do sort of psychological or supportive medical import to encourage people to follow and then ultimately use the product in traditional arteriosclerotic CLI.

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Operator [13]

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And 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 [14]

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Dave, I'd like to get your thoughts on the potential for a deal on CLI in Japan and specifically, whether it would be before or after you have the top line data.

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David J. Mazzo, Caladrius Biosciences, Inc. - CEO, President & Director [15]

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Sure. So yes, I think I've mentioned several times, we have ongoing discussions with a number of companies that would be fantastic commercialization partners for the product in Japan. They're all Japanese pharmaceutical companies, as you might guess because having boots on the ground in Japan is key to being successful in that market. I would say that our expectation based upon not only our ongoing discussions but my years of experience working in Japan and even being the CEO of the U.S. subsidiary of a Japanese pharma company is that it will be surprising if we completed a deal prior to the end of the study or any earlier decision that the MHLW might take.

The Japanese tend, culturally, to be much more analysis-prone than many other cultures to the point of some people criticizing them as having analysis paralysis. But the fact is that they will look to something to be completed before they step in. And so I think that a deal at about or just after the timing of the completion of the study is the most likely scenario. That said, there is a westernization of business practices occurring in Japan and it's not completely out of the question that one of these companies might decide to step in early and of course, we'll encourage them to keep things moving so that, that could happen if that's something they would like to do.

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Peter Enderlin, MAZ Capital Advisors, LLC - Portfolio Manager [16]

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Okay. And in that trial, have any of the subjects actually been rescued at this point? In other words, shifted from a control to a...

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David J. Mazzo, Caladrius Biosciences, Inc. - CEO, President & Director [17]

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I don't have the information in front of me as to the number of standard of care patients who have been crossed over to treatment arm. And it's probably not something that I would talk about until the -- that portion of the study is also completely enrolled.

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

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Dave, can you share any thoughts on the status of that CLBS12 in the U.S. in terms of application for RMAT, trial protocols, advocacy groups and all those kinds of things?

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

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Sure. Well, we clearly are considering and preparing an application for an RMAT designation in the United States. We think that given that the technology has already being granted in RMAT in one indication. It seems reasonable that it's likely or certainly possible that we could get it in other indications. I think the results from Japan will be supportive of any such indication. And in terms of advocacy groups, we've had a number of groups, including the CLI foundation and a cohort of cardiologists and vascular surgeons from the American College of Cardiology and the American Heart Association who have expressed a fair amount of interest to us through our Chief Medical Officer, Doug Losordo, about initiating a trial here in the United States and making this technology available to U.S. and perhaps even European patients.

It's something that we're ready to do. We have protocols designed. We know exactly how we would go about this. The biggest issue for us, as I mentioned several times, would be having additional capital available to support such a program. And once we identify said capital, I think we would be likely to go ahead and start that. But I can't give you a time frame on that right now. We're focused very much on completing what we have ongoing and getting the Phase III trial for NORDA up and running.

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

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And as far as RMAT application, it's in process, but you haven't actually submitted it yet.

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

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It's in process.

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

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Separate tack. You had a market research study done by a third party last year regarding CLI and RfA. Would you consider updating that for NORDA base versus RfA? And then adding CMD to that or similar kind of a market analysis?

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

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Actually, the analysis that was done did include CMD. And even though we called it RfA at the time, the analysis is specific to our NORDA product.

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

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Yes, okay. Now there's some very large numbers in that study, which was a third-party study, not a corporate study, as you pointed out. But do you think those numbers are still in a general sense, achievable at this point?

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

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Sure. I mean it's not a question of achievement as much as -- those studies pointed out the prevalence and incidence of the various disease states based upon independent verifiable databases. And then based upon that we took some assumptions, which were very, very modest in terms of market penetration and pricing, to establish an idea of what the market opportunity could be for us and whether or not it was worthwhile, that is, if it had a positive NPV and of course, it did, that's why we've continued forward. But all of these represent markets that are hundreds of millions of dollars, if not billions of dollars in size worldwide. And we have the opportunity, we believe, to take a significant portion of those markets, given that our products do seem to have a regenerative impact. And if approved, should benefit from rapid uptake because there are limited numbers of other treatments that have similar effects, in fact, none at this point.

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Peter Enderlin, MAZ Capital Advisors, LLC - Portfolio Manager [26]

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Right. One of your slides shows patent expiries from 2031 to 2039, and I mean I don't really know much about all that. But it seems like that's a very long period of time for a technology that has already been around for several years. So is there some specific secret to how you get that extended out so far?

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

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There's no secret, Pete. It's basically you get a 20-year patent from the time your first patents are issued. You can extend those dates by continuing to innovate and then based upon specific law associated with drug development, you can be eligible for up to a 5-year extension based upon the amount of time that the products are in development, so that you're not burning patent time developing the products; almost every product in the pharmaceutical world gets the full 5 years of additional time because most products take much more than 5 years to develop. And then if you're fortunate enough to get orphan indications or some other specific designations, they also often add to the exclusivity period. So those time lines are -- there's nothing magical about them. There -- they take advantage of all of the benefits afforded by the patent office and by drug development regulations.

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Peter Enderlin, MAZ Capital Advisors, LLC - Portfolio Manager [28]

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Yes. Great. And one last one. Since the stock is so depressed, as you said, why has there been so little insider buying, if I may ask?

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David J. Mazzo, Caladrius Biosciences, Inc. - CEO, President & Director [29]

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I'm glad you asked this question because it gives me the opportunity to address something. Insiders are forbidden from buying. And so...

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Peter Enderlin, MAZ Capital Advisors, LLC - Portfolio Manager [30]

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A lot of the time...

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David J. Mazzo, Caladrius Biosciences, Inc. - CEO, President & Director [31]

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I want people to understand that. Almost, if we're doing our jobs, then we will always be in possession of material nonpublic information, whether it's the possibility of some sort of business development transaction, the possibility of a financing, looking at data, all kinds of things that would prohibit us from legally trading in our stock. So it's somewhat unrealistic to expect insiders to constantly be buying and the only way that we can and all of us do is to participate in the employee stock purchase program, which is effectively a blinded way for us to purchase and it's limited in the amount of purchasing that we can make to a very modest number by IRS. And it only can happen semiannually, so that's really what the situation is here. And it would be, I think, unfair and unrealistic to expect insiders to be buying outside of that because we're in a blackout period almost all the time.

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Operator [32]

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And your next question comes from the line of Keay Nakae with Chardan.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [33]

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With respect to the NORDA study, once you agree on the protocol, where do you stand currently in terms of having centers lined up? And how many are you anticipating will participate in the study?

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David J. Mazzo, Caladrius Biosciences, Inc. - CEO, President & Director [34]

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Hey, Keay, thanks for the question. So we -- as I, said, we expect to have this all sorted out within the next, hopefully, couple of weeks, certainly no later than the end of the quarter and have the trial underway in the latter part of this year. At this point in time, we have already engaged a CRO, who will be helping us with this trial. We're looking at several dozen sites in the United States with perhaps a few in Canada. We've already begun site selection -- or at least early site selection, but we'll be using a number of tools that the CRO provides as well as some external foundations to ensure that we choose the sites that have the highest likelihood of being able to attract patients based upon proximity of the patients and also their interest in participating in the study. The NORDA trial will also be regulated by the requirement that participating sites have a mapping catheter, specific mapping catheter called the NOGA system. And so that will also determine where we're going to enroll, but we're well on our way in terms of preparations and once the protocol is finalized, we'll actually begin IRB approval processes in many of these areas.

Well, it seems that there are no other questions. I'd like to thank you all again for participating on today's call. We look forward to speaking to you again on our second quarter conference call in a few months and to continuing to bring you news of our achievements and progress. We remain grateful for your continued interest in and support of Caladrius Biosciences, and we wish you a good evening. Thank you, and goodbye.

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Operator [35]

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Thank you, this does conclude today's conference call. You may now disconnect.