Welcome back. I'm Jonathan Aschoff, a biotechnology analyst at Roth Capital, and we are here with Harlan Weisman, the CEO of TFF Pharma. Harlan, thanks for concluding my morning with me. Thanks very much for having me, and it's a pleasure to talk to you about your company. Yeah. So remind us, and by us I mean them, of your technology and what about it is different. So TFF stands for Thin Film Freezing, which is the name of our technology platform. Thin Film Freezing is a way of formulating drugs, particularly ones that are very difficult to formulate and not water-soluble, and turning them into dry powders. Now, you can use this dry powder for reconstitution of drugs, for oral or for intravenous use, but the most exciting aspect of it is to use it to create dry powders for inhalation. And we've done all of these things with small molecules, with monoclonal antibodies, with other large molecules, biologics, vaccines, mRNAs, even phages. But what we're emphasizing are our two lead products, TFF VORI and TFF TAC, and I can talk more about that in a little bit if you like. The advantages there is that the use is for the lung inhalation, where we can take very powerful drugs and deliver them directly to the target tissue, avoiding systemic toxicities which these powerful drugs have. And so with those—I mean, you are overwhelmingly being valued on the TFF VORI and the TFF TAC, I believe both of which you've promised some more data by the end of this quarter, which is closing pretty quickly. Is that still a valid promise, and how much more data, if you can even elaborate on that, might we see? Sure. Yeah, we are still planning to have an update on the clinical trials. By the end of the month, we will be making an announcement of that about the time that we do our earnings update. We have the two trials. One is TFF VORI for severe pulmonary fungal infections of the lung, which could be life-threatening, and TFF TAC, which is for the prevention of lung transplant rejection. We will have data. We did, as you know, have an interim presentation of data, initial presentation of data, with the data cut off last November, and we presented the data in mid-December. This will be an update from both trials. We'll have more patients, more clinical outcomes data, and more, for example, biomarker data that we will be presenting. We're very excited about those results, and we look forward to presenting that update, which will verify the early findings and substantiate that these are two really important products in our mind. As I mentioned, TFF VORI will be in patients with severe fungal infections. TFF VORI is based on voriconazole, which is the most frequently used antifungal agent for severe pulmonary infections. It's an excellent drug from an efficacy standpoint. It really works. The problem is it has a downside of toxicity, particularly things like liver toxicity, visual toxicity, even cardiac toxicities. So it does limit its use, and by giving TFF VORI inhalationally, delivering it directly to the lung, the idea is that we will see effective antifungal activity in the lung, clearance of the lung infections, but without the safety liabilities. In our update, we'll present the more recent data that we have and more patients and more follow-up from those patients. TFF TAC is based on tacrolimus, and tacrolimus is used in over 90% of patients, 95% of patients, with lung transplantation to prevent rejection. It's one of three drugs used in a cocktail, and it's the most potent of the immunosuppressives used in those cocktails. So almost all patients who've had a lung transplant are taking tacrolimus. We had a recent advisory committee, and the advisors told us that kidney toxicity is the price of doing business. They're really between a rock and a hard place when they use tacrolimus. They have to use it to prevent rejection. On the other hand, a very large number of patients develop some form of kidney impairment, kidney toxicity, which is largely irreversible, and it's something that the patients hate as well as the doctors not liking it either. With TFF TAC, again, the idea is we're delivering directly to the lung, preventing the rejection, but also avoiding the toxicities. What we will be presenting by the end of the month at our update is the additional data. We didn't have a lot of patients in our initial update. We have more patients now, and we have more clinical data, longer follow-up. All the patients are offered the opportunity to continue on TFF TAC after the end of the study. The study is 12 weeks long, but they can elect to stay on the inhalational drug. We reported before that all patients up to that point had elected to stay on it. We now have one patient that's almost a year on TFF TAC, and the other will be reporting on the additional patients that are continuing on TFF TAC. So we have a significant number of months of patient exposure where they're continuing on the inhalational drug, and they're doing well in terms of rejection. We'll be reporting those results, the safety results, and what I view as very important and exciting biomarker data from that trial. And Harlan, if my memory serves, everyone who was on TFF VORI was a transplant patient that you reported on, right? And I'm trying to remember the dosing frequency for each of the two drugs, but have you ever thought of combining those drugs for patients who have that with and also? Yeah, most of the patients were lung transplant. There was one patient, actually a control patient, that was a lung cancer patient. But in terms of your question, you're right that a very fair number of patients treated with Voriconazole for lung infections are transplant patients, and many of them are lung transplant patients. And so that idea of combination therapy makes sense. We have shown that we can use our technology to create combination products, but I would say that's in the future. Right now, we want to push forward with getting the indications as single agents, but certainly in the future, we can think about combination therapy. Can you tell us a bit about what thought leaders are saying, in particular about TFF VORI? Something where you have a few more patients than with TFF TAC? Yeah. Well, we had an advisory committee for both products recently, separate advisory committees. What we've learned, and also talking to other KOLs, is that prophylaxis in high-risk patients is becoming more and more an important area for us to explore in terms of antifungal therapy. These are patients with lung transplants who have not yet developed a fungal infection, but are at high risk. We know, certainly in the first year post-transplant, they're at high risk of developing fungal infections. But also other transplants, hematologic transplants patients, patients with leukemia, patients with acute lymphoma, patients and lymphocytic leukemia, patients with bone marrow transplant for whatever reason. These are all very high-risk patients, and doctors are now giving prophylactic antifungals, and we think that that may be a great opportunity for TFF VORI, and my colleagues and I are currently exploring the best path forward for that product. And so, remind us of what's made the TAC enrollment slower, and how many patients could we possibly expect to see data from at your quarter's release? Yeah, we will be presenting that data, so I won't say what the numbers are now, but we have seen what we consider a significant uptick in enrollment. It started slowly because this had never been done before. These are transplant patients who have lung transplants, and despite the liability of oral Tacrolimus, if the patients were stable, doctors were reluctant to take them off the oral therapy. So we had a slow approach, and as the transplant doctors became more comfortable that the inhalational therapy was working, and they were experiencing both the efficacy profile and the safety profile, that's given them the confidence to start bringing in the patients and putting more patients into the trial. And again, we'll be reporting those increase in numbers. Yeah, I mean, what you're adding to existing drugs, it really does lower the risk a lot. So to think that they're going to get on the market eventually does sound pretty highly reasonable. What kind of market opportunity, therefore, do you have for each of those? Yeah, we think both of the drugs have tremendous opportunities, and paraphrase, if not directly quote, some of the things we've heard from KOLs that, for example, TFF TAC has the real possibility of being a game-changer, that if we successfully demonstrate, and I truly believe we will, the efficacy of the drug and the improved safety profile, this could easily become the gold standard of care. And that means a very large market size. So we estimated, and the last time we publicly talked about this, over $1 billion of peak sales for TFF TAC. We've looked at this based on the additional information we've gotten and more in-depth market analysis that we think that that number is significantly higher. And we'll talk more about that when we do our end-of-quarter update, clinical update. Similarly with TFF VORI, we're incorporating into our thinking on the sales potential not only the treatment of patients, but also the prophylaxis market, and we'll be updating our thoughts on that also at the end of the quarter. Again, even at our base estimates before, we thought it was over $1 billion in annual sales. So what do you think you need to generate in terms of patients with phase 2 data for each program to give the FDA comfort on, giving you their blessing on a phase 3 design? Yeah, well, one can never predict exactly what's going to happen with the FDA, but these are serious diseases, serious disorders with very high unmet need. Certainly meets the criteria for an expedited process. Plus, they're 505(b)(2). As you pointed out, these are both approved drugs. We've changed the way they're delivered to make them more effective from a safety and efficacy standpoint. So we have that knowledge that the FDA will have and we'll present that to them. In terms of our current data package, we feel that what we have and what we'll be going over at our end-of-month clinical update is sufficient to have those interactions present our registration-enabling trials to the FDA. What can we look forward over the rest of this year, and how does that take your cash position from where it is to where it would be at the end of the year? Yeah, well, all of this is dependent on fundraising, which is something that we're very active in, and where we continuously are talking to potential investors, institutional investors. We're also talking to potential strategic partners who have shown a great deal of interest in either one of or both of the products. And we're also talking to government agencies and patient interest groups who have a track record of funding clinical development in serious conditions of interest to them. So we're still working all this out exactly what the path forward will be. We will enlighten everyone a little further on our thinking, again, when we do that clinical update call. And then outside of this, I know it's not put forth the way it had been in the past, and that's a good thing, but what kind of effort is going on? Partners, current partners looking for any new partners for drugs they're interested in, or is that really not what's happening, and you're solely focused on the internal programs? We are, I would say, we have a high degree of focus on our internal pipeline and delivering on TFF VORI and TFF TAC, but that we did not put a stop to the collaborative efforts we have underway. We do have collaborations ongoing with both big pharma companies and biotech companies. We have collaborations that we've talked about with the National Institutes of Health. For example, we have a collaboration in developing a universal shelf-stable flu vaccine. Our formulation work is ongoing now. We have another collaboration with the NIH, a cooperative research and development agreement to develop formulations of an anti-inflammatory called Hyaluronan. That work is underway. We have a collaboration with the Department of Defense to develop formulations that can be used as countermeasures to biological and chemical weapons that can be used in the field. This formulation work is ongoing. The goal of each of those programs, even the Department of Defense work, is to get them to an IND and get them into use. Of course, for the flu vaccine or for the anti-inflammatory for the lung, that means commercialization. For the government, for the Department of Defense, an IND means you get into government Department of Defense stockpiles for those countermeasures. But those are moving along. I would say each of those, in terms of setting expectations, are a ways off, probably three years off before you're really talking about an IND for any of them. And we have other programs with other collaborations that are still ongoing, and we'll see. But I think the value proposition for the company over the near term is our two pipeline products, TFF TAC and TFF VORI. Yeah, I would definitely agree with you, Harlan. Thank you very much for coming on. Thank you. Thanks for having me. Enjoyed the conversation.