Welcome to the Caladrius Biosciences First Quarter 2019 Financial Results and Business Update Conference Call. Currently, all participants are in listen-only mode. Following management's prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this call is being recorded today, Thursday, May 09, 2019. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Caladrius. Please go ahead, sir.

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 have not received this news release or if you would like to be added to the company's email distribution list, please email 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 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 it's 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, March 09, 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?

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 three 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, report topline results for CLBS14-CMD's 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 3 clinical program and have targeted initiation of that Phase 3 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?

Thanks Dave, and good afternoon everyone. I'm pleased to provide an update on our first quarter financial results highlighted by lower operating expenses 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 presenting 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 three programs. In our Phase 2 study of CLBS12 in critical limb ischemia in Japan we continue 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 a significant NIH grant support of this program, we funded the majority of all patient related enrollment costs as we target topline data readout in late 2019. Lastly, we continue to incur expenses associated with the planning and initiation of a Phase 3 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…

Thanks Joe. Let me begin by providing an update on our development programs based on our CD34 positive cell therapy platform. To repeat my comments from previous calls, 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 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 positive cell technology including but not limited to critical limb ischemia, coronary microvascular dysfunction, and refractory angina. Among others our CD34 positive 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 endstage 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 the pharmacotherapy is no longer working, angioplasty, stenting and bypass surgery have failed or are not possible and that amputation of a limb or limbs maybe the only remaining treatment for these patients. CLBS12 is currently in a Phase 2 clinical study in Japan and has received Sakigake designation from the Japan Ministry of Health, Labor and Welfare for the treatment of CLI. As a reminder, the Sakigake…

[Operator Instructions] And your first question comes from the line of Joe Pantginis with H.C. Wainwright.

Good afternoon, thanks for taking the question.

Hi Joe.

Hey there. One specific question and then one question that I guess would border as a philosophical if you don’t mind.

Sure.

Yes, the first question is, what do you feel is outstanding with regards your FDA discussions at this point, I don’t know if you can provide any color on that?

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

Got it, now that's very helpful, thank you. And then the just like I said philosophical question is, when you look at the investment case here, you really - it appears that all programs remain on track. You've been hitting your milestones as you promised. There is 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 disconnecting the shares, especially since you are trading below cash at this point?

That really is a great question and also I guess somewhat philosophical question, but you are 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 strongest fundamentals that it has 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 the real problem here is the 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 and Caladrius stock. And as people try to sell off small number 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 the people that listen to this on the 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 activities that we have, you would probably see a market capitalization or evaluation 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 an 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.

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. So thank you again.

Thanks Joe.

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

Hi Steve.

Hey, good afternoon and thank you for taking the quarter. 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 followup quickly with the leverage that you use in terms of paying for these programs all 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?

Sure steve. So I think you've underscored something that is very helpful and also should be accretive to any analysis 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 three 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 and 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 indications 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 the primary endpoint 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…

Well, thank you for describing the proper use of leverage. I look forward to the next call and progress reports that you give then, but thanks again for taking the questions.

Thanks Steve.

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

Hey Jason.

Hi David. Thanks a lot. Can you talk a little bit about the 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? Thanks.

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 is 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 enrol 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, the treatment – it is 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.

Thank you, David.

Thanks Jason.

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

Hey, Pete.

Hi Dave and Joe. Thanks for taking my questions. 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?

Sure. So yes, I think I'd mentioned several times we have ongoing discussions with a number of companies that would be fantastic commercialization partners for the product in Japan. They are 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 tends 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 will encourage them to keep things moving so that that could happen if that's something they would like to do.

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

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 is probably not something that I would talk about until that portion of the study is also completely enrolled.

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?

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 is already been granted in RMAT in one indication it seems reasonable that it's likely or certainly possible that we could get another indication 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'd mentioned several times would be having additional capital available to support such a program. And once we identify the capital I think we will be likely to go ahead and start that, but I can't give you a timeframe on that right now. We're focused very much on completing what we have ongoing and getting the Phase 2 NORDA up and running.

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

It’s in process.

A 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 basically versus RFA and then adding CMD to that or similar kind of a market analysis?

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

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

Sure. I mean, it's not a question of achievement as much as those studies pointed out the prevalence in 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, but none at this point.

All right. One of your slides shows patent expiries from 2031 to 2039 and I mean I don’t 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 fixed?

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 the drug development you can be eligible for up to a five-year extension based upon the amount of time that the products are in development so that you are not burning patent time developing the products. Almost every product in the pharmaceutical world gets the full five years of additional time because most products take much more than five years to develop. And then if you are fortunate enough to get orphan indications or some other specific designations, they also often add to the exclusively period. So those timelines are, there is nothing magical about them. They take advantage of all of the benefits afforded by the patent office and by drug development regulations.

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?

I'm glad you asked this question because it gives me the opportunity to address something. Insiders are forbidden from buying and so I want people to understand that. Almost, if we're doing our jobs then we will always be in possession of material non-public information, whether it is the possibility of some sort of business development transaction, the possibility of 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 is 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 are in a blackout period almost all the time.

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

Yes thanks. 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?

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 are looking at know several dozen sites in the United States with perhaps a few in Canada. We have already begun site selection 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 enrol. But we are 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.

Okay, very good, thanks.

Thank you, Keay. Well, if there are no other questions, I'd like to thank you all again for participating on today's call. We look forward to speaking with you again on our second quarter conference call in a few months and 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 good bye.

Thank you. This does conclude today's conference call and you may now disconnect.