Hello, ladies and gentlemen, and welcome to the TFF Pharmaceuticals 2023 corporate update conference c all. As a reminder, this conference is being recorded. At this time, all participants are on a listen-only mode. A question and answer will follow the formal presentation. If you'd like to enter your name into the queue, please press star one on your telephone keypad. I will now turn the call over to your host, Corey Davis of LifeSci Advisors. You may begin your conference. Hello, everyone, and welcome to TFF Pharmaceuticals corporate update conference call. With me on the line this afternoon is Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals, Dr. Zamaneh Mikhak, Chief Medical Officer, Kirk Coleman, Chief Financial Officer, and Bill Bivian, Vice President of Investor Relations. We'll start with a disclaimer about forward-looking statements that may be made in this call, and that these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in all our filings with the U.S. Securities and Exchange Commission, including the Risk Factors section of our 2021 annual report on Form 10-K filed with the SEC. Now it's my pleasure to turn the call over to Mr. Bill Bivian. Go ahead, Bill. Thank you, Corey, and good afternoon, everyone. Thank you for joining us for our 2023 corporate update conference call. My name is Bill Bivian. I'm the Vice President of Investor Relations with TFF Pharmaceuticals. Joining me on the call today are the two newest members of our senior management team, Dr. Harlan Weisman, Chief Executive Officer, and Dr. Zamaneh Mikhak, Chief Medical Officer. The purpose of today's call is to provide the investing community with a clear vision of TFF's corporate strategy under our new leadership and to discuss many of the significant and positive changes that we are implementing. Also, I would invite all of you on today's call to review our recently updated corporate presentation, which can now be accessed under the Investor Relations section of TFF Pharmaceuticals' corporate website and also filed as an 8-K with the SEC. Finally, I would also note that in light of the material being covered in today's call, we will be issuing a press release of our fourth quarter earnings and filing a 10-K in March as always, TFF will not hold a fourth quarter earnings conference call. As you all know, late last year, TFF announced a change in leadership. Dr. Weisman, who had previously served as vice chairman of the board of TFF, was appointed interim CEO. A week ago, on February 8th, we announced that Dr. Weisman was appointed TFF's CEO on a permanent basis. In a moment, Harlan will share his new vision for the company, the exciting opportunities that lie ahead, and what these changes ultimately mean for growing shareholder value. In early January, we announced the appointment of TFF's first Chief Medical Officer, Dr. Zamaneh Mikhak. Among the many changes that are taking place at TFF, Zamaneh's appointment should send a clear signal that advancing our promising drug candidates through the clinic and expanding our pipeline are the highest priorities for our company. Later on this call, Zamaneh will speak to TFF's clinical stage programs and what she sees as the most promising opportunity to grow our pipeline. Following remarks by Harlan and Zamaneh, we will then open up the call for a question and answer session. With that, I'll now turn the call over to our Chief Executive Officer, Dr. Weisman. Harlan? Thank you, Bill. It's a pleasure to be here today to address the investment community and explain why I'm so excited to lead TFF Pharmaceuticals. I've spent most of my career overseeing the development of major pharmaceutical products, including some of the leading biologic therapies that have generated multiple billions in global revenue. Invariably, the success of these programs was driven by advancing a highly innovative drug candidate through a rigorous, well-defined clinical program with a clear pathway to registration. Through this effort, significant value was created for investors, employees, and most importantly, for patients. Today, I can tell you without reservation TFF will be focused on building value for our shareholders by applying the same business model that has become a proven template for the pharmaceutical industry. Until this point, investors have largely perceived TFF as a technology platform company whose core mission was to license its technology to large pharma and biotech companies. The company's prior communication materials reflected this orientation, including the prior corporate presentation and prior quarterly earnings calls. Moving forward, as TFF transitions to its next phase, our core mission is to develop and bring to market high-value products from our own pipeline based on our Thin Film Freezing technology. The impetus behind this change in strategy is twofold. First, the TFF board and its new management team believe the best way to build shareholder value is to continue advancing our 100% owned clinical stage pipeline drug candidates, TFF VORI and TFF TAC, each of which has the potential to redefine the current standard of care. Second, we believe now is the ideal time to make this change. In 2023, we expect important data readouts from both programs, which will provide clinical validation of our technology. Our company must therefore be fully committed and prepared to advance both programs to the next stage of clinical development while also thinking about the most expeditious and cost-effective pathways to registration. We cannot execute on this front unless we are fully committed to providing the resources to ensure each program has the best chance to succeed. To be clear, I fully expect TFF will continue to benefit from our collaborative activity, including our foundational relationship with Dr. Bill Williams and his talented team at The University of Texas at Austin. Thanks in no small part to Bill's team's prolific research activities and extensive publications, Thin Film Freezing is now widely recognized as one of the most important advances in pharmaceutical formulation technology over the last several decades. We will continue to w ork collaboratively with Bill and his team. Look forward to sharing additional research over time. We don't expect that our new product development strategy focus will limit the upside potential from TFF's ongoing partnerships and fully anticipate that our partners will continue to evaluate our technology. We remain active and engaged on the BD front. The overarching emphasis is now being placed on value-creating activities which TFF has direct control over. Specifically, the advancement of our proprietary drug candidates. As a company, we simply cannot put our future in the hands of others, waiting on decisions that may or may not culminate in a formal transaction, particularly when we have clinical-stage assets that hold such tremendous potential. I also think it's important that everyone recognize the dynamic relationship between our product development efforts and our collaborations. Through our many industry, academic, and government relationships, TFF has significantly increased our understanding of how Thin Film Freezing can be applied in multiple disease areas and formulated across a breadth of molecular structures, including small molecules, peptides, monoclonal antibodies, mRNA, and vaccines. Despite our success in demonstrating the feasibility of Thin Film Freezing technology, thus far, we have yet to translate these combinations collaborations into meaningful business development deals. This underscores our decision to emphasize value creation through our own pipeline. While TFF VORI and TFF TAC will remain our primary product development focus, the knowledge gained from our collaborations will also help TFF evaluate future in-licensing opportunities or reformulations of known molecules that could be improved with our platform. We intend to leverage this advantage to gradually expand our pipeline in a highly selective manner. How are we actively making this transition, and what does this mean for the investment opportunity in TFF? First and foremost, we are fully leveraging our R&D talent to accelerate product development, and the recent appointment of Dr. Mikhak as TFF's first Chief Medical Officer further reflects this commitment. As all of you know, managing clinical trials is a complex undertaking that requires operational excellence and the highest level of commitment and accountability from our employees and vendors. Today, I can assure our investors that this is my number one priority as CEO of TFF. We are reviewing every existing relationship with our outside partners, tightening up processes and logistics, and making sure we have realistic timelines in place that can and will be met. Second, the best way to create value in drug development is to advance therapies that have the potential to significantly improve upon the standard of care. As I've already mentioned, the TFF VORI and TFF TAC programs are each positioned uniquely to address the significant unmet medical needs in their respective therapeutic areas, and Zamaneh will expand upon these product attributes shortly. Depending on the end markets, we also believe that TFF could successfully adopt a commercial model that leverages a small specialty-focused sales force if we decide to go that route. Our two lead candidates are examples of products that would fit such a model. That being said, we will remain open to licensing these assets during late-stage development, assuming attractive enough economic terms that would benefit our shareholders and help us reinvest and grow our pipeline. Finally, our collaborative activity and business development initiatives remain ongoing. As a board member for TFF, I was well aware of the disappointment from not consummating a major licensing deal last year. As investors know, there are inherent vagaries with trying to predict when a partner will decide to move forward with a project to a point that would precipitate a licensing deal or if it will continue in earlier stage pilot testing. These are decisions that are entirely out of our hands and frequently involve inputs that have nothing to do with the strength of our technology. We therefore believe it's prudent to take a more conservative approach with respect to issuing guidance surrounding possible licensing deal announcements. Going forward, we will not provide specific timelines or guidance until we have a deal in place that we can announce publicly. However, let me make two points on this. First, the vast majority of work being done through our existing collaborations has only served to increase my confidence in the broad applicability of our technology. Investors should not interpret our new position on guidance as in any way reflecting poorly upon our technology or the results from our partners' pilot work. Second, as we all know, larger companies tend to be more conservative in adopting new technologies, particularly when it relates to applying an entirely new formulation to clinical stage assets, which requires significant investment. As the TFF VORI and TFF TAC programs continue to move forward in clinical trials, I believe the success of these programs will demonstrate the clinical utility of Thin Film Freezing. It is my view that our product development success will translate into increasing confidence from our partners that Thin Film Freezing can be applied to their pipeline assets and successfully scaled up for use in larger clinical studies. Having reviewed our strategy, let me now spend a few minutes on execution. Without question, generating strong proof of concept clinical data in our TFF VORI and TFF TAC programs remains the most important focus for our company. We expect initial data readouts for both programs sometime later this year. We will no longer be providing specific guidance on the exact timing for these updates, and we don't expect to report data from either program in the first quarter of 2023. That being said, I will say unequivocally that if we can demonstrate strong proof of concept data in the phase II VORI and TAC studies, these readouts should serve as major catalysts for TFF in 2023. Consistent with our new product development strategy, investors can also expect TFF to provide more detailed information on the VORI and TAC clinical programs and commercial opportunities in our investor materials. From my perspective as CEO, it's mission critical that investors understand the value creation that is taking place within our pipeline and the significant growth opportunities that lie ahead for us. Thin Film Freezing will obviously remain central to our competitive advantage. As a product development company, it's also essential that we clearly articulate the clinical attributes that provide a solution to the unmet medical needs of patients. Efficient use of capital is another major priority for me and for TFF. All of the company's operational expenses are being reviewed. We are eliminating redundancies to ensure that we remain faithful stewards of our investors' capital. With that, I'd now like to turn the call over to our Chief Medical Officer, Dr. Mikhak, to discuss her perspectives on our technology and our pipeline. Zamaneh? Thank you, Harlan. I'm pleased to be here today to introduce myself and tell you why I decided to join TFF Pharmaceuticals. Optimizing drug delivery to the site of disease pathogenesis remains an elusive challenge facing the drug development industry. Only a small proportion of systemically administered drugs reach their intended target, and systemic toxicities often limit the efficacy potential of many active drugs. That is why, in my view, TFF Pharmaceuticals represents such a unique and compelling opportunity. Through its proprietary Thin Film Freezing technology platform, TFF Pharmaceuticals is one of the few companies that is entirely dedicated to addressing the challenges of drug delivery. As a pediatric allergist immunologist, I spend a majority of my clinical career taking care of patients with respiratory diseases. Alongside seeing patients in the clinic, I conducted basic and translational research at Massachusetts General Hospital, focusing on lung immunology. When I was approached about the opportunity at TFF, the prospect of delivering drugs in the respiratory space was in general very appealing to me. More specifically, I saw promise in TFF's VORI and TAC programs and a very tangible opportunity to make a meaningful difference in patient outcomes, which would organically translate into shareholder value. The voriconazole program targets patients with invasive pulmonary aspergillosis or IPA, which is a form of fungal lung infection. The mortality rate from this infection is about 30% in 12 weeks despite standard of care therapy, an astonishing rate when one considers that the mortality rate from COVID-19 is about 1%. Therefore, there is a significant unmet medical need in IPA. The TFF VORI program takes voriconazole, a first-line drug with proven efficacy, and makes it better by delivering it directly into the lung, the site of fungal infection, to improve clinical outcomes. The failure rate with IV or oral voriconazole can be attributed largely to four factors, and the TFF inhaled dry powder voriconazole would address three out of four. First, some patients can't absorb voriconazole well. Second, in some patients, the dose needs to be decreased to suboptimal levels due to toxicity. Third, in others, the dose needs to be decreased to suboptimal levels due to drug-drug interactions. Fourth, patients may be infected with a resistant strain. The direct delivery of voriconazole deep into the lungs would bypass the need for absorption through the gastrointestinal tract and addresses the first issue. Direct lung delivery would minimize systemic exposures and therefore systemic toxicities and drug-drug interactions, addressing the second and third issue. To the fourth issue, the rate of voriconazole resistance varies with the geographic region and is estimated to be about 5%- 10% in the U.S. Direct delivery into the lung would achieve high lung concentrations to drive efficacy in the setting of voriconazole responsiveness and may also capture some of the organisms with low level of resistance. The data from the compassionate use of TFF VORI in two patients with invasive fungal infection reinforced these points for me. Both patients were lung transplant recipients on tacrolimus, a drug with known renal toxicity. Both had been previously treated with systemic voriconazole and posaconazole and experienced toxicities such as gastrointestinal complications, rash, fatigue, and hair loss. TFF VORI was given at 80 mg twice a day to both patients. One patient cleared her infection within six weeks of treatment and experienced no relapse once treatment was stopped after 13 weeks. No adjustment to tacrolimus dose was needed, which speaks to the absence of drug-drug interactions. The other patient had required hospitalizations for the treatment of fungal infection in six months of the previous 12 months with significant deterioration in lung function. The patient was treated with TFF VORI for six months, leading to stabilization of lung function, improvement in lung lesions on chest CT, and no need for hospitalization for IPA. There was no evidence of drug-drug interactions between TFF VORI and tacrolimus. Since discontinuation of TFF VORI, the patient has required two hospitalizations in three months for IPA. Similar to the VORI program, the TFF TAC program aims to address another area of significant unmet medical need, prevention of rejection in lung transplant, where five-year mortality is as high as 50% in lung transplant recipients. The TFF TAC program again takes tacrolimus, the first-line calcineurin inhibitor with known efficacy, and makes it better by delivering it directly into the lung, the site of inflammation that leads to rejection and graft failure. Higher lung levels are expected to drive efficacy locally, enabling a decrease in systemic exposures to minimize toxicity. I should also mention that in addition to the overall promise offered by the VORI and TAC programs, I felt that the possibility of success of the two programs was overall quite high from a clinical development and commercial perspective, given that the therapeutic modalities used, voriconazole and tacrolimus, have years of track record of use and proven efficacy. Looking beyond TFF VORI and TAC, the depths of research surrounding Thin Film Freezing technology, including many of the peer-reviewed publications that have demonstrated how this technology could optimize drug delivery, is quite impressive. I see a great opportunity to apply Thin Film Freezing technology to address a variety of respiratory diseases using already approved or investigational molecules. This is an area of significant interest at TFF as we continue to build a pipeline of drugs to address the unmet medical need in respiratory diseases. I'll now turn the call over to Bill. Thanks very much, Zamaneh. That concludes our formal remarks, and we'd now like to open the call up for question and answer session. Operator? Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Jonathan Aschoff with Roth MKM. Please proceed with your question. Thank you. Good afternoon, and thanks for having this call. I have four questions. The first three are for Harlan. Harlan, what specific partnerable programs are your top priorities, you know, over this next coming year? In other words, in which drug and vaccine technologies does TFF add the most value and avoid the most, you know, viable competition? You know, where can you make your easiest argument to get a deal signed, I guess, would be a third iteration of that. Yeah. Jonathan, hello, first of all, and thank you for the question. As I mentioned, and I think Zamaneh did as well, our primary focus is on the internal pipeline and because we think that is where we'll add the most value, and can, bring that value to fruition for patients as well as for the company and shareholders. Having said that, you know, we've had a vast experience over the last couple years, working, with, various, collaborations with both big pharma and, with, biotech companies. It's been a tremendous education for us on the application of our technology. What we've learned are a few things. One of them is, we can really add value in the inhalational space, in inhalational products such as VORI and TAC. That can be applied to a wide variety of other molecules, and a few examples are in biologics. You know, biologics are very fragile molecules, and I'm talking about monoclonal antibodies, mRNAs, cages and so forth, and even vaccines. The approach to creating the Thin Film Freezing technology to create dry powder allows the handling of these fragile molecules in such a way that they're not damaged and then can be delivered by inhalation. You can use the same technology for reconstitution of formulations into liquids that can be used for intravenous administration or for creating orals. The reality is, what we've learned is that big pharma in particular likes to focus not on line extensions and their current product lines, but more on new molecular entities. We think there are opportunities, even with new molecular entities, where we can help them, but particularly with inhalational therapies. That would be largely for a large number of pulmonary conditions beyond what we're doing with TFF VORI and TFF TAC, including inflammatory diseases and other infectious diseases. Okay. You know, going forward, how do you plan to better anticipate and manage the potential data release delays like we've had with VORI and TAC? Jonathan, could you repeat that again? How do we expect? Better- Yeah. How do you plan to better anticipate and manage the potential data release delays you've had with VORI and TAC? Well, I think it comes down to, if I understand the question correctly, comes down to how we execute. Since I've been in my position, I've been paying specific attention to making sure that we have identified our priorities, that we have alignment throughout the organization around what those priorities are, that we've instilled the proper sense of urgency so that we can deliver on results, setting clear metrics, tirelessly monitoring progress around those metrics, and preparing for the inevitable challenges that occur in biotech along the way, and making sure we have the ability and the agility to make rapid adjustments when needed. You know, bringing Zamaneh in is a great statement to the attention we plan to spend on these things. Zamaneh is not only very bright, knowledgeable and experienced, but very much pays attention to detail and makes sure that we're able to deliver on the things that we say we're gonna deliver on. Okay. I have a short question here is, you know, will you need another trial for both VORI and TAC, or do you think that there's any way the ongoing trials can suffice for registration? Yeah. Jonathan, thanks for that question as well. You know, it's premature for us to talk about our exact regulatory strategy for two reasons. One, we need to get the results from the trials. I have a high level of confidence that we'll have positive results, but we then have to have interactions with FDA and other regulatory agencies to discuss what that exact regulatory pathway can be. You know, in terms of my own background, I have a track record of bringing innovative therapies to our market in as rapid a fashion as possible and a lot of experience with so-called expedited review pathways where you can get an accelerated approval. Whether that's possible with these products, I think, has to await the discussions we're gonna have with regulatory agencies. Well, that's fair enough. The last question is for Zamaneh. Please, what gives you confidence that TFF's technology platform is broadly applicable across a range of diseases and molecular structures? In your view, what are the most promising areas the company, you know, has yet to explore? Hi, John, thanks for the question. As Harlan mentioned, through a number of collaborations in the past few years, TFF has learned that the technology is quite applicable to a large range of molecules. There have been preclinical success in generating particles and formulations that seem quite compatible for inhalational delivery, where the molecule is small molecule or mRNA or monoclonal antibody or phages. This really opens up a very, very large horizon for us to think out of the box and think about what are the diseases, respiratory diseases that have been difficult so far to treat and where the unmet medical need is, and how can we bring innovation through the TFF technology to address these diseases. One of the areas that I think would be quite unique that we could explore is the opportunity to develop combination therapy. The TFF technology, for example, has shown that it can be applied to the generation of combination therapy, preserving the inhalational qualities that are applicable to a single molecule. This is an area, for example, that we will definitely explore and think about. Okay. Getting two drugs that aren't yet available as an inhalation, as an inhaled combination, is that at least one of the things you'll be looking at? That's one of the things we're considering, along with other things. As Harlan said, really our focus now is executing on the TFF VORI and the TFF TAC programs. I wake up in the morning, and that's the first thing I think about, and I go to sleep, and that's the last thing I think about. That is our top priority. It's our top priority because it's an area where we can actually make a difference for patients. These are drugs that there's a great deal of experience with. What we're doing here is we're asking the question of, now that we can apply these drugs and deliver them via inhalation, how can we improve outcomes? We intend to answer that question as efficiently as possible, through execution of our clinical trials and with the hope of bringing these products to the patients and create value inflection for the company. That is our number one priority. In the meantime, obviously in parallel, we're exploring, we're preparing for success. We're thinking about our long-term registrational plans, think about the data that we will get and how we would react to that in terms of scenario planning. We also are thinking about how can we put the TFF technology to work for addressing other respiratory diseases. I, thank you guys very much. That is all. Our next question is from Justin Walsh with JonesTrading. Please proceed with your question. Hi. Thanks for the updates and congrats on the new roles. I have a few questions here, so hopefully you'll indulge me. to start, it's great to see that you guys have been rounding out the leadership team here. I was wondering if there are any plans for additional senior hires this year, and if so, in what areas? Justin, hi. Thank, thanks, for the question. One of the things that I already mentioned is setting priorities. We've been going through a prioritization exercise, the senior leadership team that we have today, looking at where we have the opportunities and how we can best address the challenges that are before us. One of the aspects of doing this is identifying where we have capability gaps and how we should fill those capability gaps. It's early days. I don't want to say exactly where we think we need to fill some holes, but we are evaluating that now. We wanna be as capital efficient as we can be. We don't wanna be cavalier in excess hiring. Where we truly see a critical need that can be filled, we will go after star-level talent to fill those gaps. Got it. While we're speaking about capital efficiency here, can you remind us how much cash you have on the balance sheet and the expected runway at this point? That sounds like a wonderful question for Kirk, our CFO. Kirk, I'm gonna turn it over to you. Thank you, Harlan, and thank you, Justin, for the question. In connection with our offer back in November of 2022, that we raised $12.3 million, we disclosed in the perspective supplement that the proceeds of that offering, along with our cash on hand at the time, we would fund our proposed operating plan through at least November of 2023. At this point, our budget remains largely unchanged, and we're gonna report in Q4 at the end of March, but I wouldn't expect any surprises then. The cash runway guidance we gave in November is still very much intact. I think that we have sufficient cash runway to get us through meaningful clinical data readouts as the year progresses. Got it. Thanks. Next one here. I was wondering if you could provide some color on potential commercial strategies down the road. I think in your corporate presentation, you noted the VORI market and IPA being around 40,000 patients in the U.S. with a greater than $300 million opportunity. If you're including all of those patients in the calculation, by math, that would be about $7,500 per year. I know we're too early to really talk seriously about pricing, but I'm wondering how that compares to oral or IV VORI and how those dynamics could play out. Related to this, wondering how you plan to balance potential safety benefits of the inhaled version in these pricing considerations. Well, Justin, thanks for the question. We have been updating our market assessments, and that's something that we plan to, going forward, provide more information on. In fact, the deck, that is now gonna be available on our corporate website gives a little bit more information for VORI and TAC in terms of the market opportunity. In terms of pricing, you know, we will be competitive in terms of other inhalational therapies for and other therapies in both the antifungal and lung transplant markets. In terms of balancing safety, our anticipation, based on everything we know to date, is that because we can achieve very high levels of the drugs, whether it's VORI for the, for the fungal disease or it's tacrolimus, for lung transplant rejection, that we can achieve high levels in the lung that will achieve greater efficacy than what can be achieved with oral therapies. Secondly, because we are avoiding the uncertainties of drug levels in systemic circulation that you see with oral therapy, that we would anticipate that we should improve on the safety profile of both drugs, which would make them highly attractive in the marketplace. You know, I have the experience of bringing a few monoclonal antibodies to the market, and my experience is that if you provide clinical value, you are rewarded in the marketplace in terms of pricing. One of the things I really like about our strategy of 505(b)(2) that we're doing is that while we will get a pricing premium relative to generics, they will be much lower pricing than with many new molecular entities. That helps address two of the really important issues in healthcare. One is affordability, and the other one is accessibility. We believe that these therapies will be both highly effective from a safety and efficacy standpoint, but also cost-effective from a health economic standpoint because they're 505(b)(2). Got it. One more question for me. It seems like the versatility of the platform is well attested by your internal and external pipeline. I was wondering if you could shed some light on the factors that go into your decision to keep something in-house versus letting a partner take the lead and do a pilot study. Well, it really comes down to value creation. If we create the value, it's in our hands. We own 100% of the entity and 100% of the profitability. If we partner it off, particularly at an early stage, we give away a lot of that value. Although much of the cost is absorbed earlier in development, the future value is given up. If we hold on to these, we are creating and maximizing the value for, of those products for our shareholders. On the other hand, as I mentioned, if somebody places behind before us, if a pharmaceutical company puts before us a deal that optimizes shareholder return, we'll absolutely take that seriously and consider it. I think the best way of achieving the chances of doing that is to have our own plan for how this market how these products become profitable. That includes working out all the manufacturing aspects of as well as the clinical aspects and the commercial opportunity. You know, having been at small companies and large companies, I know that large companies have an acquisition model that in which they calculate when a product they bring in becomes accretive to them. We're much better off if we develop that model to profitability. If a, if a company comes along and we can present to them our model, and they present to us a great deal, we'll certainly consider that very seriously. Awesome. Thanks for taking the questions. Thank you. Our next question is from Dan Carlson with Tailwinds Research. Please proceed with your question. Hi, guys. Thanks for doing this update call. Appreciate it. Harlan, just congrats on being appointed CEO. I was wondering if you could start by talking about that process. Was there a formal CEO search run with other candidates, et cetera? Hi, Dan, and thanks for the question. So when I was appointed to the board in 2018, it was because I was very enamored with the promise of the TFF technology and the innovation they could bring to bear. As I already mentioned, I was enamored by the and passionate about the 505(b)(2) strategy. As a board member, I was seeing the world, you know, and knowing the details of TFF, but from a board perspective at 30,000 feet. When Glenn Mattes, our prior CEO, made the decision to step down and the board had to bring in a new CEO, they turned to me. The reason they turned to me is because of my you know, close knowledge of the company and because of my prior experience in developing and bringing drugs to market, commercialization, as well as my executive experience as a CEO of a company in the past. They asked me to take the position, but I gotta be honest with you, I was reluctant. I was hesitant because I wasn't sure I really wanted to return to an operational role. What I informed the board of is that, Look, I'll take the role, but on an interim basis, with the understanding that I might change my mind. It didn't take long, Dan, for me to be in the role. Once I began working in the role, my enthusiasm and my excitement about the promise of the technology only increased. Working with the team, and we have an extraordinarily talented team at TFF, I became even more convinced that we could bring the promise of TFF technology to many future successes, and that was something I didn't wanna give up. Almost selfishly, I said, "You know what? I'm gonna stay on this role." I need the blessing of my family, particularly my wife. Seeing how excited I was about the role, they said, "Yeah, go for it." The board certainly encouraged me and wanted me to take the role. That was the process. Gotcha. Thank you. I also have long shared your enthusiasm for the internal product pipeline. I think you've forgotten to mention one on this call, which is niclosamide, and I'm wondering if you can talk about that, 'cause that is an internal program, I believe. Well, thank you, Dan. Yeah. It is a program that, you know, we have rights to. In terms of current status, as you know, we did an arrangement with a company called UNION, meaning therapeutics. Where we are with it is that we completed, as part of the program, an initial clinical trial. There's been animal studies with niclosamide that shows promise. UNION, meanwhile, has been doing their own analysis, and together, we've been looking at the commercial opportunity and the opportunities of how we might work together on it. That, although we have a very open relationship with them and dialogues between senior management of both companies, we have not brought that to any conclusion. Gotcha. Okay. In regard to the VORI and TAC programs, I know you've had engaged in investment bank to help market partnering purposes with a data, et cetera. Have you received any outside interest in potentially partnering these programs? Yeah. What you're referring to is the arrangement we have with Torreya. That is ongoing. You know, I was out at the JPMorgan conference in San Francisco, and I met with Torreya and several interested parties, and there are other parties that have conveyed interest. Those discussions are going on in the background. None of them have advanced to a point where we'd be in any position to discuss them. Our plan, as I've mentioned, and I've even conveyed this to parties that have indicated some degree of interest, that our plan is to proceed with these molecules independently on our own, but I would be delighted to continue having discussions with them should their interest continue. If we get to a point where there's something presented to us and the executive team and the board decide to go forward, we would disclose that to the investment community, but we are not anywhere near that point. Gotcha. Just two more quick questions from me. I'm wondering if you could talk about the pace of enrollment in the phase II trials, just because It's been tough for all companies to enroll patients lately. I was curious how that's going for you. Yeah. Thanks, Dan. We've made the decision not to give the blow-by-blow on the progress of the clinical trial. What's important is that we get to a data point where there is sufficient evidence of the efficacy and of the safety of the product that we will immediately, when we have that in hand, we'll make that public, and we're certainly anticipating doing that later this year. Just, you know, we brought in Zamaneh to run these programs. She has gotten a high level of experience and knowledge of running international clinical trials. Has put laser focus on doing that. One of the things she's done is develop very close relationships with the senior management of our CRO in terms of managing bringing the sites on board and on enrollment and enrollment targets. Just an example of her accomplishments. Over the last couple weeks, two weeks ago, we had no sites open in Spain, one of our key countries. We now have over half of those sites open, and I anticipate that over the coming weeks, all of our sites will be open, all of our sites will be enrolling, both in Europe for the TFF VORI program and in Australia for the TFF Tacrolimus TAC program. Great. That's good to hear. Then my last question is, you know, as Kirk said, you know, you need more money before the end of the year. Can you just talk about what key catalysts and events, updates, investors can expect as we work our way through the year? Yeah. The most important thing is the clinical trial results. That's totally within our control. We are managing those clinical trials. We are executing on. We're focused on getting to a point where we can disclose those results later this year. I believe each of those trials and both of them together would serve, if the results are positive, which we anticipate, but if they are positive, that would serve as major catalyst for the company. As I've said, business development, which you've asked me about as well as some of the other questioners, is an upside. We are not counting on those as the catalyst. We think the value generation in our base case is gonna come from our clinical trial results. Got you. Thank you for taking my questions. Thank you, Dan, for your interest. Appreciate it. We have reached the end of the question and answer session. I would now like to turn the call back to Dr. Harlan Weisman for closing comments. Thank you. I'd like to thank all of the participants in the call for joining us today. I really hope that Zamaneh and I were able to convey to you our excitement for the future of TFF Pharmaceuticals. We strongly believe that ahead of us lies a unique opportunity to leverage a truly groundbreaking technology to develop innovative new medicines, as we've discussed, each of which have the potential to improve the standard of care. As we execute on our product development strategy, we look forward to providing future updates as we focus on growing shareholder value throughout 2023. This concludes today's conference. You may disconnect your lines at this time. We thank you for your participation.