Welcome to the Caladrius Bioscience Fourth Quarter and Full Year 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, 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.

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?

Thank you, John. And good afternoon, everyone, and 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+ 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?

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 advancing 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 are focused on the preparation and the initiation of the CLBS14 Phase 3 NORDA clinical trial and have reached a point of readiness to commence the trial. However, as we discussed during the third quarter…

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+ cell therapy platform. 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 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…

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

Hi, guys. Good afternoon. Thanks for taking the question. 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? Thanks.

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 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 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.

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

Hi guys. Thank you for the update. 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 2020. 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.

Sure. Jason. 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 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 inline with the kind of results that we saw for the symptomatic scores that we reported at AHA.

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?

So the market research we've done which is based both on a 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 two 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.

Yeah. Thank you. 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? Thanks.

Yeah, 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.

Yeah. 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.

Thanks for the update guys.

Thank you.

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

Hi, Steve.

Hi, good afternoon, gentlemen. Quick question, because there's -- you're looking at the strength and conviction of everything that you're doing in Japanese operations and now 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.

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 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 that 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.

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. In 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. Thank you.

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 eight to 10 times, 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.

Great. Well, obviously thank you for taking the questions and look forward to your question in 2020. Thank you.

Thank you, Steve.

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

Hello, Pete.

Hello. Hi, everybody. Thanks for taking my questions. 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.

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.

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

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.

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 one-time administrations and they're all fairly expensive, I mean, it depends what your perspective is and there are drugs that cost couple of million dollars. But taking the Bluebird example for one, they have this product called ZYNTEGLO, which is a one-time thing. It cost $1.8 million, I think. But their plan is to have an upfront payment. I think it's like a-fifth of the total and then four equal payments over five years, contingent on the patients actually continuing to benefit, in that case from thalassaemia indication. So would you guys consider something like that as a possible funding mechanism for patients? Because there're a lot of people that say a $30,000 $50,000 $80,000, whatever, $100,000 program is still very expensive.

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 one order of magnitude and potentially two 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 is, we don't expect to be charging $1 million for any of these one-time therapies, because we want them to be applied widely and they will be applied more widely in 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.

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

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

Okay, great. Thank you very much.

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

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 thing. Thank you and goodbye.

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