Welcome to the Caladrius Biosciences Fourth Quarter and Full Year 2017 Financial Results and Business Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded March 22, 2018. I will now turn the call over to John Menditto, Executive Director, Investor Relations & 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. Shortly before this call, we filed our Form 10-K and issued a news release, announcing our financial results for the 2017 fourth quarter and full year. If you have not received this news release or if would like to be added to the Company's email distribution list, please call our Investor Relations firm, LHA in New York at 212-838-3777 and speak with Carolyn Currin or e-mail update@caladrius.com. Before we begin, I would 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 SEC including without limitation the Company'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 22, 2018. 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 turn the call over to Dr. Mazzo. Dave?

Thanks John. Good afternoon, everyone and thank you for joining us on this call. During 2017, we completed execution of our strategy to transition Caladrius from a combined cell therapy service provider and clinical development company to a pure clinical development company with the sale of our PCT business in the middle of the year. The transition is complete and we are delighted to be reporting the meaningful progress we've made both advancing and expanding our clinical development programs. Just since our last call, we acquired a very promising late stage asset that has great synergies with our current clinical pipeline and expertise. Dose for the last patients in the Phase 2 Sanford Project, T-Rex Study, reported the results of the interim analysis of the T-Rex study and dose for the first patient in our Phase 2 clinical trial for critical limb ischemia in Japan. During today's call, I will summarize our overall progress, provide additional insight into our ongoing and planned trials, and discuss some upcoming milestones. Before I do though, 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. We are quite pleased with the accomplishments in 2017 as Dave just noted and as we look forward, we believe we're well positioned to execute financially on the initiatives we've established for 2018 and beyond. Caladrius exited 2017 with a substantially improved balance sheet and financial position. At the end of 2017, the company had just over $60 million in cash, restricted cash and marketable securities with zero long-term debt and an overall net working capital of $52 million. The restricted cash balance of $5 million which is tied to our PCT sale last year is expected to be released from escrow in full in the second quarter of 2018. By contrast, at the end of 2016 the company had only $7 million in cash, $6 million of long-term debt and excluding the PCT related assets and liabilities, a working capital of negative $1 million. Clearly, the PCT sale which generated over $100 million in non-dilutive cash over a two year period was truly financially transformative for the company. With that as an overview let me turn to our 2017 financial results. As mentioned on prior earnings calls, all PCT-related activities prior to the sale of PCT to Hitachi in the second quarter of 2017 along with the $52 million gain on the PCT sale is reported as discontinued operations. All remaining Caladrius operating activities are reported as continuing operations. I will begin with a review of the continuing operations for the fourth quarter and year ended December 31, 2017. Fourth quarter 2017 R&D expenses were $4.7 million, a 45% increase compared to the prior year quarter largely due to the initiation of our CLI clinical program in Japan, while expenses incurred in our Phase 2 T-Rex study were relatively unchanged. For the full…

Thank you, Joe. Let's start with the progress we've made with our landmark Phase 2 study of CLBS03 as a potential treatment for type 1 diabetes. We were delighted to complete enrollment of the Sanford Project T-Rex study, a perspective randomized placebo control double-blind Phase 2 clinical trial of 110 patients to evaluate the safety and efficacy of a single administration of CLBS03 as a treatment for recent onset type 1 diabetes. The trial was studying two doses of CLBS03 and the key endpoints are the standard medical and regulatory endpoints for T1D trial and include preservation of C-Peptide which is an accepted measure for pancreatic beta cell function, as well as insulin use, severe hypoglycemic episodes and glucose and hemoglobin A1C levels. The study is 80% powered to detect the 0.2 picomole per milliliter difference in AUC means C-Peptide between the active and placebo arms at 12 month post-treatment. Earlier this month we reported the outcome of the predetermined interim analysis of the T-Rex study which was triggered by 50% of the targeted total number of patients in the trial completing six months of follow-up. The interim analysis was conducted by independent statisticians and found that CLBS03 continues to be well-tolerated. The analysis also led to the conclusion that the study was non-futile as determined by predefined futility criteria for therapeutic effect meaning that a positive outcome for therapeutic effect at the end of the trial remains a statistical possibility. Of course, we have long expected that the analysis of the complete data set at the end of the trial will be necessary to fully understand the impact of CLBS03 on patients and to provide insight into the appropriate parameters to be studied in future trials. As a reminder, CLBS03 is a personalized autologous cell therapy consisting of each…

[Operator Instructions] Our first question is from the line of Keay Nakae with Chardan.

With respect to the interim analysis and T-Rex, was the futility baked only on measurement of preservation of C-Peptide or was it the other characteristics also with that?

We looked at for the interim analysis not only C-Peptide levels but also insulin used in a few of the other parameters as well. It was an algorithm that had been developed by the statisticians in consultation with our clinical team at the beginning of the study. And then they applied the analysis and transmitted to us the result.

And then with respect to CIRM funding for the study how much do you expect or how much should we model you might receive in 2018?

Well we're still figuring that out. Part of the CIRM grant was a contingent upon enrolling a certain number of patients or rather I should say treating a certain number of patients in the state of California. And other parts of the grant had to do with manufacturing and advancement on timelines et cetera. At this point, I can tell you that the grant anticipated that we were to incur a certain number of patients for treatment in California and we did not reach that milestone and we did that consciously because some of our California sites were taking a very long time to come up and be open for enrollment for a variety of reasons and many of our other sites were over performing. And so we had the choice of either slowing down the trial to try to gather every last penny from CIRM or to complete the trial either ahead of schedule or certainly at least on schedule and forgo a little bit of the support and we chose the latter. So the exact calculation is still being done internally. But I could say we’ll be maybe you know 1 million or up to 2 million maximum off of the CIRM target over the course of whole study.

Our next question is from the line of your Yi Chen with H.C. Wainwright. Please go ahead.

This is Julian on for Yi. Regarding 2018 guidance, can you just confirm less than 10 million for R&D, did I hear that correctly?

Yes. So in laying out our current platform, we will spend under $10 million to cover the remainder of our CLBS03 study in 2018, as well as what we're doing for the CLI program and the initiation of the CMD program for coronary microvascular dysfunction. That does not include anything we would do on the refractory angina front and that's going to be pending the discussion with the FDA over the course of the year. So anything that would impact that $10 million number we would provide updates to in future quarters.

And how about general and administrative guidance for this year, do you have any figures?

So we haven't provided specific guidance on that. We're pleased with ending the current year at about, just under $12 million, but from a cash standpoint less than that. We're expecting to trend similarly as we move forward into 2018 as we've stabilized our G&A infrastructure.

And we do have a follow up question from the line of Keay.

So with respect to CMD study, can you tell us in maybe more detail how you're going to assess - who's eligible to participate in that study?

Well in general terms Keay the participants that will be enrolled will have to be people who are diagnosed with CMD. And I think the rest of the enrollment criteria have been worked out but I'm not sure that I've communicated them publically. So I think we could probably take that off line. But generally speaking, these are people who have been diagnosed with coronary microvascular dysfunction that have experienced continuing symptoms and probably you are looking for improvement in their quality of life. The trial will be done principally at two centers Cedars-Sinai in Los Angeles and the Mayo Clinic in Minnesota. So two very, very well-known and reputable cardiovascular centers and I believe that both centers have – I'll call it a registry, but certainly a group of patients that are queued up to try this treatment because they've not been able to find relief in anything else. And I think I may have said in my remarks, this is a disease for which there is no approved treatment at this point in time.

Is there some sort of cutoff in terms of the amount of plaque burden they may have?

Well this is a plaque-less disease. So I don't think so I'm happy to have you speak in greater detail with our Chief Medical Officer who's not here at the moment, but we can arrange for that call. But this is a plaque-less disease. So in principle with the CMD using angiography you can't identify a blockage in the large arteries that is the principle culprit in the cause of the angina. So then assumes that it's the damage to the small arterial structure or architecture in the heart.

Okay. Yes, that's what I'm getting at. Just you know as a complete option and how would you determine that versus some minimal amount that's acceptable to be included in the study?

Again the exact details are probably best discussed with our CMO and I have to see all of the criteria. But generally speaking, these will be patients who will not have an identifiable large vessel plaque but still have the angina.

And we do have a follow up from the line of Yi.

This is Julian again. Just a quick follow up, regarding the T-Rex trial. Is it utilizing a closed system for [ex fewer] [ph] cell processing? If not, would there be any logistical differences in cell manufacturing if you were to move into pivotal testing? Thank you.

Right now the manufacturing for the T regulatory cells and the T-Rex trial is not in a completely enclosed system. I would say it’s a majority in closed system and one of the next steps in development would be to move toward that. Clearly whatever we would use in a pivotal trial will have been or would have been by us vetted to ensure that it was commercially viable both from an operational perspective, as well as the cost of goods perspective. But we are not currently in a fully [indiscernible] system. That's why the processing is done in a clean room.

[Operator Instructions] And that is all the questions we have in the queue. This concludes the Q&A portion. Would you like to have any closing remarks Dr. Mazzo? I'd like to turn it back over to you Dr. Mazzo. And this concludes today's call. You may now disconnect.