Caladrius Biosciences Inc

LSE:0HS8

Earnings Call Transcript 2018-Q3

[Operator]

Welcome to the Caladrius Biosciences Third Quarter 2018 Financial Results and Business Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, November 8, 2018.

I would now turn the call over to John Menditto, Executive Director, Investor Relations and Corporate Communications at Caladrius. Please go ahead, sir.

[John Menditto, executive]

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 filed our 10-Q and issued a news release announcing our financial results for the third quarter and 9 months of 2018 -- and first 9 months of 2018. If you have not received this news release or if you'd like to be added to the company's e-mail distribution list, please e-mail me at [e-mail].

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 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, November 8, 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'll turn the call over to Dr. Mazzo. Dave?

[David Mazzo, executive]

Thank you, John, and good afternoon, everyone, and thank you for joining us. Notwithstanding that we haven't released much on the newswire during this past quarter, a lot has gone on outside of the public eye as we advanced our product candidates while maintaining our fiscal prudence. All 3 of our ongoing clinical programs in type 1 diabetes, coronary microvascular dysfunction and critical limb ischemia remain on track for top line data based upon our previous guidance, and our newest development program in refractory angina took a major step forward in recent weeks. However, before I highlight each one in more detail, I'll turn the call over to our CFO, Joe Talamo, for his review and commentary on the financial results we reported today. Joe?

[Joseph Talamo, executive]

Thanks, Dave, and good afternoon, everyone. I'm pleased to provide an update on our 2018 third quarter financial results highlighted by focused research and development spending, lower general and administrative expenses, a strong overall cash and working capital position at quarter-end and a quarterly cash burn that has declined for the third consecutive quarter.

Before I provide additional detail on our financial results, please note that my commentary will only focus on continuing operations before income taxes compared with the prior year. As a reminder, the operations of PCT, our former subsidiary that was sold to Hitachi Chemical last year, are reported as discontinued operations in the 2017 comparative financial statements, along with a related onetime income tax benefit reported in continuing operations to directly offset the tax expense recognized in discontinued operations on the gain on the PCT sale. By excluding these items, my commentary will provide a better reflection of our actual financial results from continuing operations compared with the prior year periods.

Now turning to our financial results. Our net losses from continuing operations before income taxes were $3.5 million for the 3 months ended September 30, 2018 compared with $6 million for the 3 months ended September 30, 2017, representing a 40% overall decline. For the 9 months ended September 30, 2018, our net losses from continuing operations before income taxes were $12.6 million compared with $20.5 million for the 9 months ended September 30, 2017, representing a 39% overall decline.

Moving now to our operating expenses. R&D expenses were $1.7 million and $6.1 million during the 3 and 9 months ended September 30, 2018 compared with $3.2 million and $11.2 million for the prior year period. The lower 2018 expenses, representing 47% and 46% declines, respectively, were driven by significantly lower CLBS03 study-related costs, which were partially offset by higher expenses in our ischemic repair platform across 3 different programs. We expect this trend in spending related to our development programs to continue in the fourth quarter of 2018.

As previously disclosed, we completed enrollment and all manufacturing-related activities in the CLBS03 clinical study in December of 2017 and, accordingly, our CLBS03 study cost dropped significantly in 2018. We are now in the 12-month follow-up phase of the study and expect to incur only about $1 million in external spending to complete this study. We expect to announce the results of our CLBS03 study in late first quarter, early second quarter 2019, at which time we will provide an update on our future development plans for this program.

Within our ischemic repair platform, we incurred higher costs in the current year period due to the execution of our Phase II study of CLBS12 in critical limb ischemia in Japan. The initiation of ESCaPE-CMD, our Phase II study for CLBS14-CMD in coronary microvascular dysfunction and initial planning-related costs for CLBS14-RfA program for the treatment of refractory angina.

In addition, in the first quarter of 2018, we made a modest undisclosed upfront payment to Shire for the acquisition of the exclusive data license to CLBS14-RfA, as previously announced in March. All other transaction-related payments to Shire related to this data license will be milestone and royalty-based and contingent on the future advancement and success of the licensed program.

Overall, the majority of our R&D spending in 2018 and continuing through the first half of 2019, will be focused on the advancement of our growing ischemic repair portfolio of product candidates.

G&A expenses were $2.1 million and $7.1 million during the 3 and 9 months ended September 30, 2018 compared with $2.9 million and $9.1 million in the prior year periods. The lower 2018 expenses, representing 30% and 22% declines, respectively, were driven by lower general and administrative headcount and corporate-related activities compared with the prior year period. The 9-month period also included a $1.4 million gain on the sale of our rights to a non-core asset, a counterflow centrifugation system, or CFC device, to Hitachi Chemical Advanced Therapeutics Solutions in May 2018. Overall, our G&A expenses have declined for the third consecutive quarter as we continue to manage our G&A expenses with the strong financial discipline we've demonstrated for several years.

Turning now to our balance sheet and cash flow. We ended the third quarter of 2018 with cash and cash equivalents and marketable securities of $46.1 million and over $42 million in available working capital. Our operating cash burn for the first 9 months of 2018 was $16.9 million, including final onetime contractual PCT sale-related payments in the second quarter of 2018. Excluding these payments, our operating cash burn for the first 9 months was approximately $15 million or an average of $5 million per quarter in 2018. We expect the cash burn in the final quarter of 2018 to be approximately $5 million as well.

Based on our existing activities and projections for our CLBS03, CLBS14-CMD and CLBS12 programs and considering our cash and marketable securities balances on hand, we are confident that we can fund these programs through to the completion of their respective ongoing trials, allowing us to project the cash runway in this regard of greater than 2 years. We are amid finalizing our development plans for CLBS14-RfA, which Dave will discuss more comprehensively in a moment. And we expect those plans, once implemented, will require incremental capital, which we expect to acquire through the capital markets and/or nondilutive grant sources. Our $25 million ATM sales agreement with H.C. Wainwright remains effective, under which, to date, we have chosen to sell only approximately 150,000 shares or approximately $1 million in net proceeds. We will continue to use the facility, if and when appropriate, as an expedited path to raise funds at relatively low cost of capital.

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

[David Mazzo, executive]

Thanks, Joe. I'll begin my brief business review with a repeat of the news we released this morning, announcing the appointment of Ms. Cynthia Schwalm, former President and CEO of Ipsen North America as the newest member of our Board of Directors. Cynthia brings extensive experience in leading and managing biopharmaceutical companies during transformative years of growth, and we are delighted to have her join our board. We believe she will offer a fresh perspective while making important contributions to our strategic and operational plans, particularly with respect to the commercialization of our products. We look forward to her guidance as we continue to advance our clinical programs to late-stage development and toward registration and eventual launch.

Let me now turn to a discussion of advances in our development programs, beginning with those based on our CD34-positive cell therapy platform. To those who have listened to my previous calls, I apologize for the redundancy of some of my remarks. But for the growing list of newcomers joining our call, it is vital that we provide the rationale behind our platforms. Heart attack, congestive heart failure, angina, critical limb ischemia and stroke are often caused by an acute or chronic deficit in the supply of oxygenated blood. This deficit is typically due to disease in the large and small blood vessels or capillaries that serve the target tissues. Historically, the clinical focus of treatment has been on strategies to address the problems in large vessels, leading to the use of clot-busting drugs, angioplasty and stents to treat heart attacks and percutaneous and surgical revascularization for chronic ischemic conditions. Yet, to date, no therapy has been designed specifically to address the defects in the small blood vessels, which contribute to the overall impairment of patients with acute and chronic ischemia.

It has long been known that one of the body's responses to coronary disease is the recruitment of CD34-positive cells to ischemic tissue. These cells, which reside naturally in the bone marrow, are preprogrammed to repair damage to the small blood vessels or microcirculation in all tissues. CD34-positive cells have been shown to induce angiogenesis or the development of new blood vessels, thereby contributing to the prevention of tissue death by facilitating blood flow. At Caladrius, we are now advancing 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-RfA for the treatment of refractory angina.

Let's start with CLBS12, our proprietary CD34 technology specifically formulated for intramuscular administration for the treatment of lower extremity ischemia. As I've explained previously, critical limb ischemia is a severe obstruction of the arteries that significantly reduces blood flow to the 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 Phase II clinical evaluation in Japan and has received SAKIGAKE designation from the Japan Ministry of Health, Labour and Welfare in the treatment of CLI. For those unfamiliar with the nomenclature, SAKIGAKE designation is similar to breakthrough or RMAT designation as awarded by the FDA in the United States and promotes research and development in Japan, driving early practical application for innovative pharmaceutical products, medical devices and regenerative medicine.

With CLBS12 as a designated therapy under this system, Caladrius enjoys 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 CBS12 -- 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 data generated in our ongoing 35-subject perspective, randomized, controlled, open-label multicenter study in no-option CLI patients in Japan. The study comprises 35 subjects, divided into 2 cohorts: a 30-subject group with traditional arteriosclerotic CLI; and a 5-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 received standard of care with drugs approved in Japan, including antiplatelet agents, anticoagulants and vasodilators, the choice of which is made by the investigators during -- 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. CLI free status is a highly clinical -- a highly clinically relevant end point and encompasses the broader spectrum of improvement in time to amputation or amputation-free survival, which are the historical end points for CLI studies. Our confidence in this approach to CLI is supported by the substantial clinical data from 4 prior trials in CLI and claudication conducted in the U.S. and Japan, which showed CD34 cell therapy was not only safe but also improved CLI free status and amputation-free survival in those trials.

Trial completion remains on target. And in fact, I'm pleased to announce that the Buerger's disease cohort is fully enrolled. We remain confident in our expectations to report top line data from the complete study in the early part of 2020. As to costs, we project it will require less than $7 million of additional expense to complete this study. Since these costs are part of our current operating budget projections, this study can be considered fully funded to completion. As I have indicated on past calls, our strategy is to partner CLBS12 for commercialization in Japan. And to that end, our conversations continue with prospective partners, and we continue to expect to consummate a deal in concert with the completion of the study.

Finally, 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, the commencement of such a program being a function of the identification of the corresponding necessary capital.

Moving on to CLBS14-CMD, our proprietary CD34-positive cell therapy for the treatment of coronary microvascular dysfunction. The 2 CLBS14 programs, CMD and RfA, both employ CD34-positive cells isolated, harvested and concentrated in the same way as for CLBS12 but formulated for intracoronary or intramyocardial injection, respectively, specifically for repair and regeneration of cardiovascular tissue.

CMD is a plaqueless heart disease involving damage to the inner lining of the tiny arterial blood vessels in the heart. CLBS14-CMD is designed to reduce this damage by exploiting the innate ability of CD34-positive cells to repair small blood vessels and increase microcirculation. ESCaPE-CMD, our Phase II clinical study of CLBS14 for the treatment of CMD, is enrolling well and according to plan. As we have previously communicated, most of the costs associated with this trial are covered by a grant from the NIH. And as such, this study should also be considered fully funded through completion.

Now let's turn to our newest CD34-positive cell therapy program, CLBS14-RfA. CLBS14-RfA is intended for the treatment of refractory angina, and we have worked rapidly since acquiring the exclusive data license to this asset to reactivate the IND and to file for and secure RMAT designation, regulatory milestones that are key to the efficient advancement of the CLBS14-RfA program.

We see the addition of CLBS14-RfA to our CD34 portfolio as a core component of our business strategy. The RMAT designation makes cellular therapies eligible for the same actions to expedite development and marketing application review that are available for small molecule drugs that receive breakthrough therapy designation, including increased meeting opportunities, early interactions to discuss potential surrogate or intermediate end points and the potential to support accelerated approval.

Our enthusiasm for this program is based on a series of published Phase I, II and III data that include a consistency of therapeutic effect with CD34-positive cells to increase exercise tolerance, improve heart functionality and decrease long-term mortality associated with the condition.

After receiving the RMAT designation, and by the way, we believe we are the only active cardiovascular development program with such a designation, the next step in the process was to request and conduct a Type B meeting with the FDA. I am pleased to announce that we recently completed this meeting, the goal of which was to obtain FDA guidance regarding the requirements for registration of this product under the terms of its RMAT designation.

Our assessment of the meeting was that it was positive and collaborative and reinforced our expectation that FDA would demonstrate maximum flexibility afforded under the RMAT system regarding remaining development steps necessary to bring this minimally manipulated autologous cell therapy product to registration. We will be working with the FDA in the coming weeks to finalize our development plans and to formalize the minutes of the meeting and any follow-on discussions, and we look forward to providing further details once these actions are completed.

Lastly, let's turn to our landmark Phase II study of CLBS03 as a treatment for type 1 diabetes. Our CLBS03 program, using autologous ex vivo expanded and activated polyclonal T regulatory cells has several key global regulatory designations, including FDA orphan drug status, EU advanced therapeutic medicinal product classification and FDA Fast Track designation. As to the latter, we believe that CLBS03 is the first type 1 diabetes program ever to receive Fast Track distinction. These regulatory designations are key as they provide various exclusivity benefits, tax credits for certain research, a waiver of the new drug application user fee and priority review of regulatory approval submission.

As you know, in March, we reported results from the prescribed analysis of the Sanford project T-Rex study, a prospective randomized, placebo-controlled, double-blind Phase II clinical trial of 110 patients to evaluate the safety and efficacy of CLBS03 as a treatment for recent onset type 1 diabetes. The interim analysis was triggered by the completion of the 6-month follow-up of 50% of the targeted total number of subjects in the trial. The analysis will conduct -- was conducted by independent statisticians and showed that CLBS03 continues to be well tolerated and led to the conclusion that the study was nonfutile as determined by predefined criteria for therapeutic effect.

We remain on track to complete the 12-month follow-up on all 110 patients by year-end and to reporting top line data in early 2019. We expect the trial will provide a tremendous amount of data, which we will evaluate rigorously in order to define the next steps in the development of what we will hope will become an important new tool in the treatment of children with recent onset type 1 diabetes. We project only about $1 million of remaining expense to complete execution of this trial. And since it is also part of our existing plan, consider this fully funded to completion.

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 refractory angina 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: working with FDA to finalize the development plan for registration for CLBS14-RfA for the treatment of refractory angina, continue enrollment of our Phase II clinical trial of CLBS12 for CLI in Japan, continue enrollment in the ESCaPE-CMD Phase II clinical trial of CLBS14-CMD and complete the 12-month follow-up on all 110 patients in the Phase II T-Rex study and announce top line results.

As you can see, despite the lack of recent news announcements, Caladrius continues to make measurable progress advancing its development programs. Our enthusiasm for our pipeline is reinforced by the fact that we believe, to the best of our knowledge, that we are the only company with development programs that have been awarded, respectively, with SAKIGAKE and RMAT designations. And our dedicated and passionate team remains keenly focused on realizing the potential of the exciting and promising technologies that address large unmet medical needs in cardiovascular and autoimmune diseases.

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

[Operator]

[Operator Instructions] Our first question is from the line of Steve Brozak from WBB.

[Stephen Brozak, analyst]

There's 2 items that I'm kind of curious about. The first one is, you've given a litany of different programs and everything that are able to use leverage. And in the partnering that you've got, what would be the, let's say, cash equivalent? Or what would you think would be the cash equivalent that we might want to think about in terms of what you've been able to conserve or partner with other folks so that we could think about what the values are? Because, obviously, you've been conservative in terms of your -- spending your cash and the expenses. How should we look at that? And I've got one follow up, please.

[David Mazzo, executive]

Thanks for the compliments and for the questions. I think the best way to look at that is to look at maybe a running summary of all of the nondilutive capital that we have been able to achieve through grant awards going back to, perhaps, even the early 2016 time frame. So if you look at all of the current ongoing programs and, in fact, you include some of the awards that were committed for CLBS20 back then, we've attracted about $40 million in nondilutive funding from a variety of sources, including the California Institute for Regenerative Medicine, the Juvenile Diabetes Research Foundation as well as contributions to equity and operating expenses from our research partner, Sanford Research.

[Stephen Brozak, analyst]

Okay. And in terms of the different programs that you're talking about because, obviously, on the CLI side, you've got terribly affected sick patients. And one of the particular parts here is that in different programs that we've looked at where new therapeutics were being involved, there was a bit of a consideration or even, in some cases, there were issues around the safety and the combination because, obviously, these are patients that are being treated in different modalities and you always have to concern yourself when you're adding one more thing. What can you tell us about, and I don't know how you would describe this, the lack of concern or the differentiation in terms of the therapeutic approach that you're talking about not having to consider what are, in conventional terms, what used to be the drug-drug interactions of the past and looking at the involvement of new therapies?

[David Mazzo, executive]

Yes. Actually, I'm going to take advantage of the President -- the presence of our Chief Medical Officer, Dr. Doug Losordo and ask him to comment on that because Doug, as many of you know, and if you don't, I'll take the opportunity to introduce him, is one of the pioneers in CD34-positive cell therapy, having essentially initiated work on this when he was an academician back at Tufts, continued that work when he was at Northwestern and then through his career in the industry. And I think since he's been actively shuttling back and forth to Japan, he's in the best position to comment on that question. Doug?

[Douglas Losordo, executive]

Thanks, Dave. And thanks for the question, Steve. It's a very important question because, as you point out, this is a very sick patient population. But in the case of CD34 cells, I think we're in a unique position. First of all, it's an autologous cell therapy, which already gives you a sense of the level of safety that we're talking about. But on top of that, even among other autologous cell therapies, the CD34 cell, to my knowledge, is the only cell that is actually the naturally occurring cell designed by nature to do what we are targeting it to do, which is to reconstitute the microcirculation. We're also advantaged by the fact that over 700 patients have enrolled in clinical trials using CD34 cells in various indications. And without exception, the patients who receive cells have a better safety profile and measurable improvements and clinical outcomes. And that includes the 3 CLI studies that have been done so far, 2 in Japan and 1 in the United States, that have all showed better safety outcomes and better clinical outcomes in the patients who received the cells. So as we're now on around 14 years of experience with these cells, our level of confidence in the safety profile is actually quite high.

[Stephen Brozak, analyst]

And a follow-up in terms of the comparator because, obviously, other entities are looking and trying to go out there and offer any solution which is, in some cases, the standard of care is not really very good, it's palliative. How are the clinicians looking at this and saying, when you go out there and present, how did they look at it, differentiate it, saying, okay, I can either look at a different approach, which may have some significant downsides or you. What's the answer there? And I'll hop back in the queue.

[Douglas Losordo, executive]

Sure. So I mean -- I think that's a good question. I started out my career as a cardiologist, and so I have lots of contacts in the field. But I'll just give you an anecdote maybe from a recent interaction that I had in Japan. One of the clinicians there had enrolled a patient in the study, it just happened that, that patient had come back in for a 3-month follow-up visit on the day that we visited the hospital. And this had been a patient in their clinic for quite a long time with severe CLI, rest pain and non-healing ulcer. And all I can say is that I could see the surprise on the doctor's face by the fact that this patient has come back. And the way he described it, he saw a smile on the patient's face for the first time ever because her pain was gone and the ulcer had healed after a single dose of their own CD34 cells. When we've surveyed docs and showed them the accumulated data in these patients, the response is pretty uniform that they see this as a pretty significant advance and something that were it available that they would apply to their CLI patients.

[Operator]

And our next question is from the line of Keay Nakae from Chardan.

[Kaey Nakae, analyst]

With RfA, obviously, you have data from prior Phase I, II and III studies. You've got the meta-analysis that's been published. What I haven't heard you say is whether a scenario where that's enough to file for registration is going to be viewed as acceptable, and appreciating that you're waiting for the written notes from a most recent meeting, but then how do we think about whether that's still on the table as a possible scenario?

[David Mazzo, executive]

Thanks for the question, Keay. I want to be clear, I think in our estimation, the RMAT designation should allow the FDA to give guidance that foregoes the traditional development requirements for a product, namely Phase I, Phase IIa, Phase IIb, 2 full Phase IIIs and perhaps, a bunch of associated preclinical testing. I think that at this point, and you can understand my reticence to say anything definitive until we're clear with the FDA because I think we have to view them as a partner and don't want to put them in a difficult situation, but our expectation is that we will not be required to do 2 traditional full Phase IIIs or any additional preclinical work. And so if that is, in fact, what is finalized, then we will consider that a major win and a big step forward because we will have gone from essentially no program in refractory angina at the beginning of this year to now a program that is perhaps a single study away from BLA registration. That's not to say that the opportunity to define a path to perhaps even conditional approval with existing data is completely off the table, but I don't think that any of us should count on that at this point in time. But we'll, obviously, continue those discussions, and we'll let everybody know of the outcome once we finalize things with FDA.

[Operator]

And our next question is from the line of Kate Enderlin from MAZ Partners.

[Peter Enderlin, analyst]

Yes, Pete Enderlin. Dave, when actually was that Type B meeting that you just talked about?

[David Mazzo, executive]

The meeting actually occurred last week, on October 30.

[Peter Enderlin, analyst]

Okay. And when you say that the relevant terms of the RMAT designation were applied, what terms actually are relevant to this whole procedure?

[David Mazzo, executive]

So allow me to give a little primer on RMAT, and I'll try not to be too long-winded. But you know that there are various designations for small molecules, biologicals and now cellular and gene therapies. And the regenerative medicine advanced therapeutic, or RMAT, classification, in fact, embodies all of the benefits of Fast Track designation and breakthrough designation as they would be applied to, say, small molecules. So that allows us to have frequent and less formal interactions with FDA. And by less formal, it doesn't mean that they're any less important, it just means that we don't have to go through, for every interaction, the process of requesting a meeting, waiting a certain period of time that's prescribed in the guidelines for FDA to respond, schedule a meeting, submit a briefing book, et cetera, et cetera. It allows us to make phone calls and have discussions in an ad hoc fashion as we progress through to save time and to focus. It also allows the agency to -- it provides for them to take decisions that allows them, as I just said a moment ago, to forgo some of the traditional steps in development in a manner that they would believe would still ensure the safety and efficacy of the product with the expressed objective of finding a means to get these safe and efficacious cellular therapy products to patients faster than would be the case in a traditional scheme. So that's available to us. We also will be eligible for a shortened review time, 6 months instead of 12. And there's even a provision for the agency to consider conditional approvals and accelerated approvals based upon a number of provisions. So all of those things, which are made available to all programs that are designated RMAT, are available to us. And they're part of the discussion that we've now initiated with FDA, starting with the Type B meeting last week.

[Peter Enderlin, analyst]

Okay. And then, what does "formalize" the minutes of the meeting actually mean? I mean...

[David Mazzo, executive]

In light terms, it means that FDA issues final written minutes. So the process is essentially -- we have a meeting...

[Peter Enderlin, analyst]

It's just a transcription, basically, right? I mean...

[David Mazzo, executive]

No, no, it's not necessarily -- no, in fact, it's not a transcription. There's no transcript of the meeting. The meeting minutes will be a documentation of, to some extent, the salient points of any discussion that was held but, most importantly, a documentation of the agreements, decisions and prescribed next steps that were -- that came out of the conversation between us and the agency. And so that process of formalization, it actually goes through a system at FDA that requires them to issue written minutes within a certain prescribed period of time. It's usually within a month of the meeting or thereabouts. And until those meeting minutes are written, most companies, and certainly we, are reticent to go into too much detail because we want to be sure that we don't get ahead of ourselves in interpreting something that may not be quoted in exactly the same fashion in the minutes.

[Operator]

[Operator Instructions] And we do have a follow-up from the line of Kate Enderlin from MAZ Partners.

[Peter Enderlin, analyst]

Dave, you have an ATM, of course, as you mentioned, for up to $25 million and the shelf registration for up to $150 million. So how do you sort of balance the factors, the decision between equity financing and these alternatives? And included in those alternatives would be things like joint ventures, out-licensing or a partial sale of some program may be for some geographical area or something like that, so how do you look at all of that and sort of come up with a strategic perspective?

[David Mazzo, executive]

Thanks, again, Pete. The simple -- the answer is actually kind of simple. It really comes down to financial evaluations. So we always seek the lowest cost of capital available to us. It would be as if you're out buying a home, you always look for the lowest mortgage rate under the best terms from the most reputable lender. And so that's the same thing we do with capital. We look for the lowest cost of capital that are the most reliable sources and the ones that we believe are most reputable. So that includes -- so obviously, if we could get nondilutive funding of the type that we collected in the past where it has little or no strings attached, basically, a grant, well, that's pretty cheap money, if you will. And so we'll take that first. And then we look at the other sources and decide what makes the most amount of sense. And factored into that is also the consideration of, as I said, the source of the capital and bringing larger institutions into our shareholder list. And the support that they would naturally bring is a strategic consideration that gets factored into the value of any offer that's made by such an institution to buy our shares, so that's how we do it. And it's the same calculus for out-licensing, partnering or joint ventures. It really comes down to the terms and what makes sense in the long run for our shareholders.

[Peter Enderlin, analyst]

It's kind of difficult to calculate the cost of setting up a joint venture, though, isn't it, or out-licensing or something like that compared to...

[David Mazzo, executive]

No, no. The costs are quite obvious because, in those agreements, you typically -- not typically, you absolutely define the share of the product that's going to be offered up in exchange for a consideration from the partner or the other member of the joint venture. So if you are forming a joint venture or creating a partnership, that means that you're giving up access to some portion, whatever is defined in the agreement, of the future revenues and profits of the product. And you have to see what that means in terms of what they're offering in the short term and whether that makes sense or no.

[Peter Enderlin, analyst]

Right. But that means you have to sort of have a pretty good idea of what you're giving up in terms of...

[David Mazzo, executive]

Yes, we do, of course.

[Peter Enderlin, analyst]

And then I have one more, if I may, that probably should be for Doug, and that's relating to CLI. Pluristem recently got approval for something called Expanded Access Program for their CLI product which, I guess, means that they -- somebody else pays for it, and the patients get the treatment. And what are the implications for you with their somewhat competitive CLI product and that kind of approach to financing it?

[Douglas Losordo, executive]

Sure. No, thanks for the question. It's a little bit hard for me to comment on the Pluristem product since, to my knowledge, no data on the use of that product in CLI patients has ever been published outside of, say, a descriptive press release from the company. I don't think there's ever been a peer-reviewed publication. It's very hard for me to say too much about if and how it's competitive with what we're doing in a setting of the multiple published study results that we have. I guess, in theory, a compassionate use situation could be competitive, but I'm not really sure what the parameters of that are and how that would attract the attention of physicians in the absence of any data.

[Peter Enderlin, analyst]

Yes. So the vehicle that they're using is really just kind of an alternative to some compassionate use, and it doesn't really got to do with the efficacy of the program, is that fair?

[Douglas Losordo, executive]

Yes, I think that's fair because there's again -- now it's, of course, possible that there is data in existence that just hasn't been released. But as I say, I'm just not aware of any evidence of efficacy that's ever been published.

[David Mazzo, executive]

Yes. I think just to reiterate, I don't think we should draw any conclusions about the efficacy or safety of any product that has granted expanded access or compassionate use because it just means it's part of a larger clinical database that still remains to be evaluated.

[Peter Enderlin, analyst]

Right. Okay. Well, again, congratulations on all the progress that's going on and on the new board member, too.

[David Mazzo, executive]

Thank you very much.

[Operator]

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

[David Mazzo, executive]

Again, I thank -- I'd like to thank you all for participating on today's call. We look forward to speaking with you again on our next quarterly conference call and to continuing to bring you news of our achievements and progress. And we remain grateful for your interest in and support of Caladrius Biosciences. Have a great evening.