Caladrius Biosciences, Inc.

Welcome to the Caladrius Biosciences 3rd Quarter 2021 Financial Results and Business Update conference call. Currently, all participant lines are in a listen-only mode. Following management's prepared remarks, there will be a question and answer session. To ask a question at that time, please press the star key followed by the 1 on your touchtone phone. If anyone has difficulty hearing the conference call, please press star 0 for the operator assistance. As a reminder, this call is being recorded today, Thursday, November 4th, 2021. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications at Caladrius. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. Welcome to Caladrius' third quarter 2021 conference call to discuss our financial results and provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer, Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer, and James Nisko, Vice President of Finance and Treasury. Earlier today, we issued a press release announcing our third quarter 2021 financial results, which is available under the investors and news section of the company website, along with the webcast replay of this call. If you have not received this news release or would like to be added to the company's email distribution list, please email me at jmendito at collateralist.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 Colliderist. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its forms 10-K, 10-Q, and 8-K, which identify specific risk 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 live broadcast, Thursday, November 4th, 2021. Colleges Biosciences undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. Please keep in mind that the company continues to conduct calls from different locations during the COVID-19 pandemic, so we appreciate your patience should we have any technical difficulties. With that, I'll now turn the call over to Dr. Mazzo. Dave?

Thank you, John, and good afternoon, everyone. As always in these continued trying times, I hope you are all in good health and remain safe. Thank you for joining us today on our third quarter business update conference call. During this quarter, Caladrius continued to advance and optimize its CD34 positive cell technology-based clinical programs while maintaining a strong financial position that will fund operations for the next several years, all this despite the challenging environment brought on by the COVID-19 pandemic. Notably, the company strengthened and further diversified its operations and management team with the addition of several highly qualified and experienced personnel including the appointment of Kristen K. Buck, MD, as Executive Vice President of Research and Development and Chief Medical Officer. Kristen's wealth of knowledge and extensive medical, regulatory, and safety expertise across many therapeutic areas will prove instrumental during the company's evolution as we continue to advance and expand our clinical development programs and execute upon our vision. Kristen is particularly adept at focusing research and development on product development and already has made great impact on the execution and efficiency of our current programs. We are delighted to have someone of her caliber as part of our executive team here at Caladrius, and you will have the opportunity to hear from her firsthand as she will provide an update on our clinical development programs in a few moments. Before that, though, I'll turn the call over to James Nisko, our Vice President of Finance and Treasury, to review and provide commentary on our financial results for the quarter. James?

Thanks, Dave. I'm pleased to join today to present a summary of our third quarter financial results, starting with operating expenses. Research and development expenses for the three months ended September 30th, 2021 were approximately 4.1 million compared to 3 million for the three months ended September 30th, 2020. Research and development in both periods focused on the advancement of our ischemic repair platform and related to expenses associated with efforts to continue execution and acceleration of enrollment of the FREEDOM trial, expenses associated with the planning and preparation of an IND and phase one proof of concept protocol for CLBS 201 as a treatment for diabetic kidney disease, and ongoing expenses for Honedra and critical limb ischemia and Berger's disease in Japan associated with maintenance of manufacturing facility and personnel qualification, as well as contract research organization engagement. General and administrative expenses, which focus on general corporate related activities, were approximately $2.8 million for the three months ended September 30th, 2021, compared to $2.3 million for the three months ended September 30th, 2020. representing an increase of 22%. This increase was mostly due to a large increase in D&O insurance premiums, as generally experienced across our industry, and strategic consulting expenses. Overall, net losses were 6.9 million for the three months ended September 30th, 2021, compared to 5.3 million for the three months ended September 30th, 2020. Turning now to our balance sheet and cash flow. As previously announced, in January 2021, we successfully closed on a $25 million capital raise through the sale of the company's common stock and warrants to several institutional and accredited investors in a private placement priced at the market under NASDAQ rules. Shortly thereafter, in February 2021, the company announced that it closed a $65 million capital raise through the sale of its common stock and warrants to several institutional and accredited investors in two registered direct offerings priced at the market under NASDAQ rules. In addition, in May 2021, we announced that we received $1.4 million in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority. That program enables qualifying New Jersey-based biotechnology or technology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations. Even at the tail end of the COVID-19 pandemic, while many small biopharma companies continued to experience difficulties and competed for capital, we successfully and opportunistically secured $90 million in new capital gross proceeds year-to-date in 2021. These resources have afforded us the financial security to focus on the execution of our business plan. As of September 30th, 2021, we had cash, cash equivalents, and marketable securities of approximately $100.1 million. Based on existing programs and projections, the company remains confident that its current cash balances will fund its operations for the next several years. That completes the financial overview. With that, I will now turn the call to Dr. Buck. Kristen?

Thank you, James, and good afternoon, everyone. I'm excited to join you today on my first Caladrius quarterly conference call and look forward to engaging with all of you in person in the months and years ahead. My focus throughout the first months at the company has been spent on evaluating and refining development strategies for existing programs in order to maximize the probability of clinical and commercial success. all while minimizing the capital outlay needed to achieve the next developmental milestone in each program. In addition, I have been immersed in the company's search for new assets to add to our development portfolio, both to diversify development risk and to increase development opportunity. As most of you know, Colladrius is focused on the development of autologous cellular therapies designed to both treat and or reverse disease. We have clinical programs underway based on a large database of human clinical data. To date, our therapies have shown strong signs of efficacy and durability with an excellent safety profile, unlike many allogeneic therapies. Importantly, we believe that curative cell therapy products, when applied to the right indication and at the right price, can restore human health and improve quality of life with a single administration of the therapy rather than a treatment that requires frequent readministration. Our CD34 positive cell therapy 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 preclinical and human clinical studies have demonstrated that administration of CD34 positive cells induces angiogenesis of the microvasculature. That is, 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 that several conditions caused by underlying ischemic injury can be improved through the application of our CD34 cell technology, including but not limited to critical limb ischemia, we call CLI, and Berger's disease, coronary microvascular dysfunction, or CMD, and diabetic kidney disease, known as DKD. That said, I will now expand on each of our clinical programs in numerical order, kicking off with CLBS-12 Honedra in Japan, our product candidate for the treatment of CLI and Berger's disease. Honedra was awarded a Sakagaki designation from the Japanese regulatory authorities for the treatment of CLI in Berger's disease, an orphan-sized subset of CLI. The Sakagaki designation is akin to an RMAT designation in the United States and affords the recipient prioritized regulatory consultation, a dedicated review system to support the development and review process, including the option of a rolling registration submission as well as reduced review time of six months for the registration application once filed. Additionally, under Japan's regenerative medicine guidelines, products such as Honedra are eligible for early conditional approval and possibly full approval in Japan based on the assessment by the regulatory authorities of the data from the trial or trials designed in direct collaboration with the Japanese PMDA. Note that conditional approval of Sakagaki product only requires the demonstration of a trend toward therapeutic effect together with acceptable safety. Now, as you might expect, the Sakagaki designation is a highly sought regulatory classification in Japan. And we hope that this, coupled with positively trending data from our trial, will make Honedra an attractive product for partnering to a Japanese pharmaceutical company. The company's study of Honedra in Japan for the treatment of CLI and Berger's disease has shown positive results to date. The initial responses observed in the subjects who have reached an endpoint in this study are consistent with a therapeutic effect and safety profile previously reported in published clinical trials in both Japan and the United States. However, as discussed in prior quarters, the multiple states of emergency declared by the Japanese government over the last 18 months due to the COVID-19 pandemic have made incremental enrollment exceedingly challenging. While the trial is demonstrating positive trends in both efficacy and safety, which are the key criteria for consideration of conditional approval in Japan under the Sakigaki designation, we have concluded that it is in the company's and our shareholders' best interest to suspend our enrollment efforts with the objective of minimizing the operational and financial burden that we have and continue to incur due to enrollment delays and the lack of visibility on time to completion. Our near term focus in Japan will be on securing a partner to complete the study by enrolling the four remaining no option critical limb ischemia subjects if deemed necessary and or to explore the possibility of submitting the existing data to the Japanese regulatory authorities under the Sakagaki designation. Now, earlier this year, we reported that the United States Food and Drug Administration, the FDA, granted orphan designation to CLBS-12 as a treatment for Berger's disease. We very recently received a response from the FDA regarding our briefing document and questions about a potential CLBS 12 development program in the United States for Berger's disease. The FDA's response has led us to believe that a clinical program of some size and cost would be required for U.S. approval, especially since they felt that the existing data out of Japan would not be representative of the Berger's disease patients in the United States. Based on that guidance from FDA, we have decided not to pursue the development of CLBS12 in Berger's disease in the U.S. at this time. Turning now to Zalma CLBS16 for the treatment of coronary microvascular disease, CMD. CMD is a disease that continues to be underdiagnosed and potentially afflicts millions annually. a vast majority of whom are female with no current treatment options. The company is committed to raising awareness of this growing women's health crisis and finding an effective treatment. In May of 2020, Caladrius announced the full data results from the ESCAPE-CMD trial at the Society for Cardiovascular Angiography and Interventions 2020 Scientific Sessions virtual conference showing a highly statistically significant improvement in coronary flow reserve correlating with symptom relief for patients with CMD after a single intracoronary injection of zauna. Subsequently, earlier this year, the company initiated and is currently treating patients in a rigorous Phase IIb clinical trial known as the FREEDOM trial, which to our knowledge is the first controlled regenerative medicine trial in CMD in the United States. The FREEDOM trial is a double-blind, randomized, placebo-controlled trial designed to assess the efficacy and safety of delivering autologous CD34 cells, our Zalma product, to subjects with CMD and without obstructive coronary artery disease. Investigator and potential subject response to the FREEDOM trial has been favorable, and while early enrollment in the trial proceeded as planned with the first patient treated in January of 2021, The impact of the COVID-19 pandemic in the United States has contributed to the general slowing of enrollment to date. In an effort to accelerate enrollment, the company has expanded the number of participating investigational sites and modified the study protocol to broaden the array of available techniques acceptable for diagnosing CMD and thereby opening trial participation to a much larger number of sites throughout the US. This and other protocol amendments intended to facilitate enrollment were implemented in the latter part of the quarter after agreement with the FDA, and we will assess the impact of the protocol changes on enrollment in the coming months, at which time we expect to provide an update on enrollment feasibility and completion with final data expected approximately six months after last patient, last visit in the study. Lastly, and most recently, proposed development program for CLBS201 for the treatment of diabetic kidney disease, DKD. The company plans to initiate a phase one open label proof of concept trial evaluating CLBS201, a CD34 positive regenerative cell therapy for intra-renal artery administration in patients with DKD. Although still pre-dialysis, these patients exhibit rapidly progressing stage 3B disease. Progressive kidney failure is associated with attrition of the microcirculation of the kidney. And preclinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. The protocol pending final approval from the Institutional Review Board calls for an open label, staggered, sequentially dosed cohort of six patients overseen by an independent data safety monitoring board. A key readout of the data will occur at the six-month follow-up visit for all patients. The company projects enrollment of this study to begin in the first quarter of 2022 with data from all subjects expected by the first quarter of 2023. Finally, as I mentioned previously, we are in the midst of a concerted effort to identify and secure an additional development asset or assets to complement our current portfolio of product development candidates. Based on the quality and breadth of available opportunities, as well as the continued advancement of our existing development portfolio, I am excited about our prospects. and see a bright future ahead of us for Caladrius. And I look forward to discussing specifics with you in the future. With that, I will now turn the call over to Dave.

Thank you, Kristen. Overall, we are very pleased with the corporate and development achievements made in the third quarter. Throughout the remainder of the year, we expect to maintain and even build on our execution and strategic evolution with a focus, as always, on driving shareholder value. And with that overview, operator, we're now ready to take questions.

As a reminder, to ask a question, please press the star key followed by the one on your touchtone phone. Please offer only one question per listener at a time, and then be prepared to return it to the queue for any additional questions. Our first question is from Kumar Raja with Brookline Capital.

Thanks for taking my question. So first with regard to the Honedra in Japan, how does this impact the expenses near term? Do you think that all the expenses in Japan would be taken care of?

Kumar, thank you very much. Thanks very much for your question. And I think it's worthy to spend a little bit more time on Honedra. So the specific answer to your question is we expect to save several million dollars, or I should say avoid about several million dollars of expense in 2022 as a result of the decisions that we've taken here. We've borne quite a large expense since February of 2020 in Japan, maintaining manufacturing facilities, personnel qualifications, CRO engagements, et cetera, and have unfortunately been able to enroll essentially no patients during that period of time because of the states of emergency. So we believe that this is a prudent action going forward from a financial perspective.

And with regard to the diabetic kidney disease, typically how much do these patients deteriorate if they are not treated?

Well, I'm going to ask Kristen to comment in a moment, but as you heard her say, what we're looking to do is to identify patients who are likely in the roughly stage 3B section of the disease and who are rapidly progressing so that we'll be in a position to measure a change in the rate of progression during the period of time that they'll be followed. Kristen, do you want to add anything to that?

Yeah, thanks, Dave. The only thing I would add is, you know, it's almost impossible to come up with a number that determines their rate of deterioration. As Dave said, we're looking for patients who are sort of maxed out on their medications, who have diabetes, who sort of are under control with their medications, but we think that they will be rapidly progressing in an effort to find, you know, a rate of change in such patients. But I think To answer your question succinctly, one can't determine that, and that's been the bane of a lot of clinical drug developers' problems over the years to be able to identify who and how quickly these people decline.

So the expectation is that potentially there will be a stability in the disease progression or they won't progress as much.

Well, our goal here, Kumar, again, to be very clear is, you know, we see this as a regenerative therapy if it will work. And if it does work, then it will compete in a marketplace where there are currently oral daily medications that already slow the progression of the disease. Our goal with CLBS201 is to demonstrate that we can regenerate kidney function. So we're not looking simply to slow or stop the progression of the disease. We actually would like to see a regeneration as manifested by an increase in GFR rather than a continued decrease in GFR. It's a high hurdle, but we think it's one that's appropriate for what could be a regenerative therapy.

Okay. And in terms of the background, you know, diabetic levels of these patients, how are you going to control for that and how is that going to have impact on this?

Again, I'll let Kristin respond.

Yeah, thank you, Kumar. The eligibility criteria for the trial defined the diabetic kidney disease patients that they should be on stable diabetic medications, stable kidney medications for periods of time prior to study entry. And they have study-defined lab criteria, which are akin to the other chronic kidney disease trials you'll find clinicaltrials.gov. So they will be stable for a period of time prior to study entry.

Okay. And finally, with regard to CMD, it looks like we will have an update soon on that. Is it mostly driven by what's happening with the COVID-19 situation?

Yeah, I think generally one could classify this as a program that's been greatly impacted by by COVID. Remember, the original protocol required patients to have a CFR measurement, you know, as a screening, CFR measurement at baseline, and then a CFR measurement at six months. All of those required visits to the cath lab, which involved visits, obviously, to facilities that are impacted by COVID, and in many cases were restricting the access to non-COVID patients. In addition, as part of the treatment, a patient has to sit through an apheresis, And that's another facility restricted procedure during the COVID times. So, you know, we expect that a number of the protocol changes that Kristen has implemented, which will expand the types of CFR measurements that are being allowed, will actually minimize the number of invasive treatments and generally facilitate enrollment in a number of other ways. will hopefully increase enrollment, and also as the COVID pandemic becomes more and more under control. But a number of these protocol amendments have really just been implemented, and it will take several months for us to be in a position to measure the impact. So we're hoping that by the end of the year, we'll be able to measure the impact, and on our next conference call, we'll be able to give you an update on where we stand.

Okay, great. Thank you so much. Thank you, Kumar.

Your next question is from Emanuela with HC Wainwright.

Hi, Emanuela. Good afternoon, everyone. Good afternoon. And thank you for taking my questions. And I wanted to welcome Dr. Bach to the team. First, a general question regarding the trial enrollment across the different programs and the current impact of the pandemic that seems to be evolved but still present. I guess, what are you hearing more specifically from the site? Are these issues of staff shortage or they are still related to less patient-seeking treatment because of COVID or a combination of all these factors? And also, I guess, Honedra is a specific case, but do you find that these issues are different in different geographies?

Thanks, Emanuela. Yeah, I think you've hit it right on the head here as it relates to our programs. Not to be repetitive, but I think it's worth making sure that everyone on the call understands when a patient wants to go through an autologous cell therapy treatment with one of our products, they have to undergo a number of office visits with a physician. They have to undergo an apheresis procedure, which usually occurs either in a dialysis unit or an apheresis unit, which is often in a hospital or clinical setting. And then they have to go through the actual administration, which takes place either in a hospital, in a catheter laboratory, an operating room, et cetera. All these facilities have been patient access restricted to one extent or another during the COVID pandemic because facilities were either trying to limit the number of patients coming in without COVID so that they wouldn't be exposed, because staff has been migrated to those units treating COVID because there has been a great increase in the number of people with COVID, because patients, you know, and then we had the issue, as you mentioned, of patients being reluctant to seek treatment during these times. They've been staying home, you know, isolating, and facilities have lost staff. because they've either moved them to COVID units or staff has been relocated to work remotely, if it's administrative staff and coordinating staff, or simply they've become burnt out and they've left the jobs. And so we've felt impacts from all of that across all geographies. And then in Japan, we had the added impact of the Japanese government indicating health states of emergency almost consecutively beginning in February of 2020 until very recently. And during those states of emergencies, all major hospital facilities were restricted from treating anything other than COVID-related illnesses. So clinical trials like ours, which required hospital facilities, were simply stopped and we couldn't enroll any patients during that period of time. So it was a little worse from an enrollment perspective in Japan, but we have to a great extent, many of the same challenges in all geographies.

Yeah, yeah, thank you for that. And regarding Onedra, with only four patients remaining and given the persistence of the situation, I was wondering if you have talked more recently to the regulatory authorities in Japan about submitting the existing data set and also about Are there any precedents that could support a positive outcome for this possibility? And then I have another question about the rolling submission.

Okay. So the idea of precedent is a little tricky because under the regenerative medicine law and with the Sakagaki designation, the Japanese regulatory authorities essentially worked directly with us to define a trial of, I'm going to say arbitrary size, arbitrary because it's not statistically driven at all. So they decided that 30 patients in no option CLI and five patients in Berger's disease would be an interesting enough population that if we were able to demonstrate safety and a trend toward efficacy in that population, that that would be sufficient for them to consider us for at least a conditional approval, if not a full approval. You know, to date, we have 26 critical limb ischemia patients and seven Berger's disease. We have two more than the original five in agreement with the regulatory authorities. So we have a total of 33 patients instead of 35. The number is not statistically driven. And so we think that there is the opportunity for flexibility here, but it does require the Japanese regulatory authorities to agree to that. And the particular issue that we have as a non-Japanese company is that these discussions are typically held in person with the Japanese regulatory authorities and Americans are still not allowed to travel to Japan for anything other than essential services. So we've been prohibited since February of 2020 from going to Japan and having this discussion with the Japanese authorities. And our best guess is that it won't be until early 2022 when we would be allowed to go to Japan and have that meeting. And of course, we have to request that meeting and then have it scheduled. So it's probably going to be well into the spring. For that reason, we think that a Japanese company would be better placed to have that conversation because they're already there and they can go whenever they want. And that's why we're focusing on efforts on trying to secure the partnership now.

Okay, that's very helpful. Thank you. And this is like, I don't know if this is possible, but since the plan is for a rolling submission process, Could you potentially begin the process ahead of the completion of the study, maybe when you have a sense of how long it's going to take you to complete the study?

The rolling submission, in theory, could start at any point in time, but the trigger for the rolling submission is a face-to-face meeting with the PDMA. So we've been told from that perspective as well, and that's why we're not in a position to start the rolling submission. And we would need a partner to work with us on that in any case.

Okay. Okay. Got it. Got it. Okay. Thank you for that. Very helpful. And I guess I wanted to follow up on what you were talking about, broadening the techniques used for CMD diagnosis for the Zona program. Maybe if you can just... Talk to us a little bit more about the protocols, Amanda, you implemented to facilitate enrollment.

Sure, I'll make a brief comment and then I'll turn it over to Kristin to give you some more details. But just recall that at the beginning of the trial, we had stipulated that CFR was to be measured using a Doppler technique using a specific catheter that was made by Philips. And since the start of the trial, Phillips has decided to discontinue that trial. So it's only got very limited availability. That was a particular issue. And then only using an invasive toppler technique also posed some challenges relative to patient enrollment. So we've opened it up to a variety of additional invasive and non-invasive techniques. And I'll now let Kristen give you some of the specifics about those.

Yeah, hi, and thank you for the warm welcome. As Dave said, we've opened it to both invasive and non-invasive. And what we're looking for is things like coronary blood flow, response to acetylcholine, myocardial perfusion reserve, myocardial flow reserve, or index of myovascular resistance. And we're looking at different methods without getting into too much granular detail as thermodilution techniques, MRI, and cardiac PET scans. And so what this allows our investigators to do is to use whatever their site typically uses for coronary ray activity and functional coronary activity tests. So it has allowed us to open up our enrollment quite significantly, and hopefully we'll see those results in the coming quarter.

Got it. That makes sense. Thank you very much.

Thanks, Emanuela.

Your next question is from Pete Enderlin with MassPartners.

Hi, Pete.

How are you?

Good. Thank you. You've given us a lot of specific information. I just have a couple of sort of broader questions left at this point. One is, you know, we're looking at the fact, I guess you'd say, that you really haven't had any recent success in obtaining non-dilutive funding, you know, from foundations or patient interest groups or whatever. Are there differences in the availability of funding, you know, the amount of money that these different organizations would have available for, for the three main disease areas that you're dealing with, you know, cardio and vascular and, and kidney. Um, it's so that there's some that are more opportunistic targets than, than others with that regard, or they're basically not a whole lot of money available for any, for non dilutive funding.

Well, you know, thanks Pete for that, for that question. And I'll just remind you, you know, that we, we did get, um, about $3 million of non-dilutive funding from the state of New Jersey from the sale of our net operating losses.

You already had that. It was just a matter of monetizing it, so I'm not counting that.

I'm talking about getting money from... Okay, so from the grant perspective, there are a number of sources, but the principal sources for non-dilutive grants come from either the federal government through a variety of its agencies or... specific disease-related foundations like the American Diabetes Association or the American Heart Association. Most of those organizations have a cycle for grant application and review that runs on the calendar year so that you typically put in the proposals in the early part of the year the reviews take place, and by mid-year, if you're funded, you find out, and you often get the funding by the end of the year, and then that funding, you know, depending upon its magnitude, can be spread out over one or multiple years. The types of fundings available from a lot of the, I'll call it disease-related foundations, is often specifically directed to new clinical investigators, to to clinical sites, and often to academic institutions. It's very unusual for those organizations to provide financial support to public companies for research and development. They may help by working with patient groups to help with recruitment, et cetera, but they often just simply don't give money. Now, in the case of the NIH and other organizations, government organizations, every year they have a stated focus on the types of diseases that they would like to see treated. And so they put out a request for proposals in those areas. And we typically apply for every single grant for which we have even a small chance of being able to achieve them. And we've made those applications. But the number of applicants far exceeds the amount of money that's being distributed. And so that's where we stand. But we continue to make application whenever there's something for which we're eligible. And we hope that we will eventually get some additional grants. And notwithstanding the fact that you don't count it, $3 million of real cash in our pockets is real money. And I think it's important to not discount that. And there'll be more New Jersey NOLs in the future.

Okay. Well, thanks for that clarification. I just have one more which also relates to funding, I guess, in a way. And that is when you consider opportunities for strategic funding or partnerships, does the fact that all of your programs, and you've emphasized that on this call, are for one-time therapies, does that in a way limit the appeal to some of these larger companies? Because and big biotech companies is recurring treatments. And, you know, I think one-time treatments are a great thing, but maybe that's not as appealing to some of the potential strategic partners.

Well, you know, and I can't speak for them specifically. We've not received feedback with that being the reason why they wouldn't be interested. I think, you know, what most people would assume is that for a curative treatment or a treatment that has a very infrequent dosing, you know, spread out by years, for example, that the pricing would be commensurate and so that they would still be able to make a profit, an appropriate profit over time. So I don't think that that's really been the biggest issue. I think the bigger issue is simply that they are understanding that the pandemic has had an influence on the kinds of things that can be advanced during COVID. the clinical development, you know, trials, and they're just waiting to see when we're able to generate some additional data, and we're hoping that that's something that, you know, certainly in 2022 is something that we're looking forward to doing.

Okay. Well, thanks. That's very helpful. Thank you.

Thanks, Pete.

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

Well, again, thank you all for participating on today's call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on the company's achievements and progress. We remain grateful for your continued interest in and the support of Caladrius Biosciences. Stay well and have a good evening. Goodbye.

This does conclude today's presentation. You may now disconnect.