Good afternoon, ladies and gentlemen, and welcome to the TFF Pharmaceuticals, TFF TAC, and TFF VORI program update conference call. As a reminder, this conference is being recorded. I will now turn the call over to our host, Corey Davis of LifeSci Advisors. You may begin your conference. Thank you, operator. Hello everyone, and welcome to TFF Pharmaceuticals' TFF TAC and TFF VORI program update conference call. With me on the line today are Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals, and Dr. Zamaneh Mikhak, Chief Medical Officer. Before we get started, as shown on the second slide, I'd like to remind everyone that this call will contain forward-looking statements, including, without limitation, statements about the advancement of TFF TAC and TFF VORI into registration-enabling clinical trials and the benefits of the company's TFF platform. 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 our press release issued today and in our periodic SEC filings. Now it's my pleasure to turn the call over to Dr. Harlan Weisman. Harlan, go ahead. Thank you, Corey, and good afternoon, everyone. Earlier today we issued a press release providing an update on our two clinical programs, TFF TAC and TFF VORI. This afternoon we will be presenting additional data from each program that highlights how Thin-Film Freezing is enabling the safe and effective pulmonary delivery of tacrolimus and voriconazole. In a moment our Chief Medical Officer, Dr. Zamaneh Mikhak, will review these updated data sets. As previously announced, we recently made the decision to prioritize the advancement of TFF TAC, and I'd now like to spend a few minutes discussing the rationale for this decision and why we believe TFF TAC represents a therapy with groundbreaking potential in the field of transplant medicine. After considering a broad range of factors, including the clinical data generated to date, overwhelmingly positive feedback from key opinion leaders, KOLs, and clinical investigators, and an updated assessment of the opportunity in lung transplantation, we have determined that TFF TAC should be prioritized to help accelerate its clinical development and pathway to registration. Dr. Mikhak will provide an overview of the highly encouraging data from the TFF TAC phase 2 study, which of course forms the primary basis for our decision. I should also note that Professor Gregory Snell, who is medical head of the lung transplant service at the Alfred Hospital in Melbourne, Australia, and lead principal investigator of the phase 2 TFF TAC trial, will present the updated data from this study in detail on April 13 at the 44th annual ISHLT meeting. ISHLT stands for the International Society for Heart and Lung Transplantation, and this meeting is considered the premier global transplantation conference. He will review the updated data in an oral presentation in a late-breaking clinical science abstract session, and we are obviously quite excited about sharing these data with the medical community. As I mentioned, we are encouraged by feedback that we are receiving from many KOLs and clinical investigators who see the potential of TFF TAC to become an important new immunosuppressive therapy in lung transplant medicine, an area which unfortunately has seen few therapeutic innovations over the last several years. For decades, tacrolimus, both in its IV and oral form, has served as a cornerstone of immunosuppressive therapy for patients receiving a lung transplant. While the drug is effective, it comes at a great cost to the patient, particularly within the lung transplant setting where higher levels of immunosuppression are required versus other organ transplants. Unfortunately, the higher dosage of tacrolimus leads to significant systemic side effects, particularly kidney toxicity. Considering the fragile health for many transplant recipients, this has remained a point of frustration for many physicians. Based on the highly encouraging data we have generated thus far in our ongoing Phase 2 trial, we have seen a growing level of physician interest in the TFF TAC program, which provides us even greater confidence that TFF TAC represents a truly innovative new therapy with the potential to improve how immunosuppression is delivered to lung transplant recipients. Another factor that has led us to prioritize TFF TAC was that enrollment rates are expected to be higher in general for clinical trials of TFF TAC compared to TFF VORI, leading to earlier potential value inflection points, which are clearly a priority for us. Finally, we have performed a more complete assessment of the total market opportunity for TFF TAC, which we now estimate could be well over $2 billion in peak annual sales compared to our earlier $1 billion estimate. While predicting peak revenue estimates for any mid-stage pipeline asset can be challenging, we believe TFF TAC represents a level of innovation that has not been seen in transplant medicine for three decades. And if we were able to establish a new standard of care in the field of immunosuppression, then we believe TFF TAC could indeed have multibillion-dollar potential. To be clear, this decision to prioritize TFF TAC is not being made because of any issues with TFF VORI. In fact, the safety and efficacy data from the Phase 2 study and our expanded access program, or EAP, continue to suggest that TFF VORI is generating strong antifungal activity with a favorable safety and tolerability profile. As we progress through our clinical program, however, we have received consistent feedback from clinical investigators that antifungals are now more commonly being used in the prophylactic setting with success, which is reducing the opportunity within the treatment setting. Given the considerable expenditure that would be required to develop TFF VORI in the prophylactic setting, including the need to enroll a large number of patients in the range of 350+, we have determined that the best use of capital would be to advance TFF TAC. What we know about TFF VORI is that based on the totality of data from our Phase 2 study and the EAP, the product has maintained a solid safety and tolerability profile and has been effective in treating invasive pulmonary aspergillosis. We therefore remain open to exploring collaboration or licensing agreements for this asset, and we have already held preliminary discussions with various parties. We may also have the opportunity to further advance TFF VORI ourselves if we are able to secure significant non-dilutive funding from government-based entities. We certainly welcome these discussions and believe TFF VORI remains a highly valuable asset within our pipeline. I'd now like to turn the call over to our Chief Medical Officer, Dr. Mikhak, who will review updated patient data and treatment outcomes for the TFF TAC and TFF VORI clinical programs. Zamaneh? Thank you, Harlan. I'll first provide an update on the TFF TAC phase 2 trial. As a reminder, TFF TAC aims to address a significant unmet medical need in lung transplantation. Patients receiving a lung transplant have an expected five-year mortality rate of approximately 50% due to oral tacrolimus's narrow therapeutic index. Too little immune suppression results in acute rejection or chronic rejection, leading to chronic lung allograft dysfunction or CLAD, whereas too much immune suppression leads to infections, chronic kidney disease, and post-transplant malignancies. There are approximately 40,000 lung transplant patients globally, which represents a significant opportunity. By introducing TFF TAC, we hope to improve upon the current standard of care by delivering tacrolimus directly to the lung to optimize lung immune suppression at reduced systemic exposure levels so as to limit systemic toxicities. Our ongoing phase 2 trial of TFF TAC is an open-label single-arm study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. The study is designed in two parts. Part A is a 12-week treatment period, and Part B is an optional safety expansion period. Prior to receiving treatment, patients enter a two-week screening period to collect several baseline measurements. Baseline kidney function is documented, and bronchoscopy is performed to make sure patients do not have a lung infection. A biopsy sample taken during bronchoscopy is used for genomics analysis to look for baseline signs of acute Rejection. Spirometry is performed to assess the patient's lung function. Blood is drawn to measure Donor-Derived Cell-Free DNA, which serves as a non-invasive biomarker of stress or injury to the transplanted lung due to rejection. Finally, lung imaging is performed to look for infection, inflammation, and damage from chronic rejection. Once screening is completed, patients' oral tacrolimus is stopped, and patients enter the 12-week treatment period with TFF TAC. Clinicians then monitor tacrolimus blood levels and adjust the dose of TFF TAC as needed to achieve target tacrolimus blood levels that are approximately two-thirds to one-half of the patient's blood levels on oral tacrolimus. These blood levels are expected to be high enough to avoid rejection but low enough to reduce toxicities. Following the treatment period, the same endpoints measured during the screening phase are reassessed, including spirometry for lung function, bronchoscopy and biopsy for genomic analysis, and donor-derived cell-free DNA for signs of stress or injury to the transplanted lung. Safety and tolerability are assessed throughout the study, including assessment of kidney function through glomerular filtration rate and creatinine levels. Patients are then given the option to enter the trial's open-label expansion. As this next slide shows, we have added 4 additional patients to the trial, and here we present the demographics and baseline characteristics of all 8 patients. As you can see, patients range in age between 41-73 years, with the 4 new patients being on average younger, in their 40s and 50s, compared to the first 4 patients who are in their 60s and 70s. Patients are equally divided between male and female. The majority are white, which is not surprising given that the study is conducted in Australia. Time since transplant ranges from 9 months, or 0.75 years, to 23 years, and 2 patients enrolled to date around 1 year post-transplant. None of the patients have chronic lung allograft dysfunction or CLAD. They all suffer from chronic kidney disease, which is an enrollment criterion, with duration of renal insufficiency ranging from 2.5 years to 7 years based on the available data. Patients have been in the study for 5 weeks to 49 weeks, with median duration of approximately 16 weeks as of March 25, 2024. As you can see, 4 patients have completed 12 weeks of treatment, and all 4 patients have chosen to continue on TFF TAC by proceeding to Part B. It is important to point out that we have now accumulated a significant number of patient days on TFF TAC therapy. On a cumulative basis, as of March 25, 2024, these first 8 patients in the phase 2 trial represent nearly 174 weeks, or 1,200 days, on TFF TAC therapy, which amounts to approximately 3.3 years. Given no evidence of acute rejection, we are obviously pleased with both the quality and duration of these data, which I might add is also translating into a growing enthusiasm among our Phase 2 clinical investigators. Back in December, we reported initial safety and efficacy data for the first four patients in the Phase 2 study. We have now doubled the number of patients enrolled in the study with an additional four patients, and I'm now pleased to report that all eight patients have successfully transitioned from oral tacrolimus to TFF TAC. Consistent with the data from the first four patients, as of the safety and efficacy data cut of March 8th, we have found no evidence of acute rejection, including: no clinical signs and symptoms suggestive of acute rejection, no need for pulse steroids to treat acute rejection, no deterioration spirometry suggestive of acute rejection, and no chest x-ray findings suggestive of acute rejection. Biomarker data, namely gene expression data using MMDx, will be disclosed at the ISHLT meeting on April 13th. And as I already mentioned, all four patients who completed Part A chose to remain on TFF TAC and proceed to Part B. I should add that we are particularly excited about the gene expression data we're generating in this trial. We have not seen any clinical signs of rejection, and we're interested in doing a deeper dive and evaluating rejection at a molecular level. Endobronchial biopsies are obtained before the start of TFF TAC while patients are on oral tacrolimus and after 12 weeks of treatment with TFF TAC. Gene expression profiling on endobronchial biopsies is done to assess risk of rejection and injury in the transplanted lung. Gene expression MMDx data give one actionable results based on evidence of T-cell mediated rejection, antibody mediated rejection, acute and chronic injury, atrophy, fibrosis, and endothelial damage. Without disclosing any details, I will say that the biomarker data provides supportive evidence on a gene expression level for TFF TAC in prevention of rejection. With respect to safety, treatment with TFF TAC has resulted in no mortality, no TFF TAC discontinuations due to an adverse event. The majority of treatment emergent adverse events were Grade 2 or lower in severity, and kidney function has been maintained. As you can see in the table at the bottom of the slide, patients' stable dose of TFF TAC is approximately 1/6, or 17%, of their stable dose of oral tacrolimus, and their blood tacrolimus trough levels on TFF TAC are approximately 2/3, or 66%, of the blood trough levels on oral tacrolimus. Therefore, we do not see any evidence of rejection on TFF TAC at stable doses that are 1/6 of the oral dose and blood trough levels that are approximately 2/3 of the oral level. In other words, TFF TAC appears to provide sufficient immune suppression to prevent rejection of the transplanted lung at a fraction of the oral tacrolimus dose and at a fraction of oral systemic exposures. We predict that by reducing blood levels of tacrolimus, patients may experience fewer side effects versus the oral formulation, which would in turn lead to long-term health benefits. We continue to make significant progress in advancing the TFF TAC program. With respect to regulatory considerations, the FDA has endorsed the 505(b)(2) pathway for TFF TAC clinical development, and the agency has also granted TFF TAC orphan drug designation. We also plan to apply for FDA-expedited programs to help accelerate our pathway to registration. We are currently planning to open an IND in the U.S. and begin a U.S. phase 2 trial, which could potentially seamlessly transition into a global phase 3 study, thereby saving additional time and expenditures. We will need to get sign-off from the FDA to pursue this clinical development pathway. We would expect that a single phase 3 study for TFF TAC will be sufficient for registration, given the FDA endorsement of the 505(b)(2) pathway and the availability of considerable historical and real-world safety, tolerability, and efficacy data with the use of oral tacrolimus. The sample patient size for the Phase 3 study is estimated to be approximately 200 patients at this point with sites active in the U.S., Canada, Australia, U.K., and select EU countries. With respect to our 2024 milestones, we held an advisory board meeting in February, providing us with valuable input that we incorporated into our development plans. Looking ahead, as Harlan mentioned, we're pleased that Professor Gregory Snell will be presenting updated Phase 2 data for TFF TAC at the upcoming ISHLT meeting on April 13th in Prague with an oral presentation in a late-breaking clinical science abstract session. We are expecting additional data on TFF TAC in the third quarter of this year. And finally, we anticipate opening the IND in the U.S. in the summer of 2024 to initiate a Phase 2 study in the U.S. I'll now provide an update on the TFF VORI program. TFF VORI has been in development as a potential treatment for pulmonary fungal infections, starting with invasive pulmonary aspergillosis, or IPA. IPA is a life-threatening fungal lung infection that primarily affects immunocompromised patients such as patients with hematologic malignancies or individuals who receive solid organ or stem cell transplantation. Voriconazole is first-line therapy for patients with IPA. However, when administered orally or intravenously, voriconazole is associated with high rates of toxicity and drug-drug interactions, thereby limiting its effectiveness. Patients with IPA have a 12-week mortality rate of approximately 30%, pointing to a significant unmet medical need for this rare disease. There are approximately 250,000 patients globally with invasive aspergillosis, which we believe represents a significant opportunity for TFF VORI. Thin-Film Freezing technology enables us to address this opportunity by delivering voriconazole directly into the lungs where the fungal infection resides. Through localized delivery, we hope to drive efficacy while minimizing the patient's systemic exposure and thus systemic toxicities and drug-drug interactions. The Phase 2 trial evaluated TFF VORI versus oral voriconazole in a 3:1 randomization after 13 weeks of treatment in an open-label study. The trial endpoints included safety and tolerability, clinical, radiologic, and mycologic responses, as well as all-cause mortality. The parameters that established the disease status at baseline, such as evidence of infection, signs and symptoms, lung function, and lung structural abnormalities, formed the endpoints of this study. Treatment response was assessed by mycologic response, defined as clearance of the aspergillosis infection. By clinical response, defined as improvement in signs and symptoms or lung function via spirometry. And/or by radiologic response, defined as improvement in lung structure via chest CT. As a reminder, we launched our EAP in July to provide access to TFF VORI for patients in need who do not qualify for phase 2 study. The EAP provides 12 weeks of treatment with TFF VORI to patients who have limited or no other treatment options or who have had an unfavorable response to adequate standard of care therapy. Our EAP encompasses many forms of pulmonary aspergillosis and also includes patients who have pulmonary fungal infections other than aspergillosis that are responsive to treatment with voriconazole. Our U.S. Expanded Access Protocol was submitted to the FDA late spring of 2023, and the EAP remains open in the U.S., Canada, Australia, the U.K., and select EU countries. Back in December, we reported on the initial safety data from a total of seven patients treated with TFF VORI through our phase 2 study or the EAP. Of these seven patients, five had completed at least eight weeks of TFF VORI therapy and were, therefore, also eligible for assessment of treatment response. The initial data presented in December demonstrated the effectiveness of TFF VORI as an antifungal and pointed to a favorable safety and tolerability profile. Given the availability of considerable historical and real-world data on safety, tolerability, and efficacy for oral voriconazole, we found the data from TFF VORI to be directionally informative and sufficient to move towards phase 3 development. We subsequently stopped enrollment in the phase 2 study to focus resources on next steps for the program. The Expanded Access Program is still open and is continuing to enroll patients. As of March 8th, two additional patients have enrolled in the EAP, bringing the total number of patients who have received TFF VORI up to nine. We have follow-up safety data on one of the two new EAP patients. Therefore, we can provide updated safety data on eight patients today. With respect to efficacy, one additional patient from our phase 2 study completed TFF VORI therapy and, therefore, became evaluable for treatment response. This brings the total number of patients for assessment of efficacy to six. As this chart shows, the overall efficacy and safety profile of TFF VORI remains mostly unchanged since our prior update. Five of six patients achieved the clinical response with TFF VORI, which we define as improvement in signs, symptoms, and/or spirometry. Five of six patients achieved the mycologic response, meaning no evidence of fungal infection on follow-up assessment. Three of four patients who had an abnormal chest CT at baseline and also had a follow-up chest CT achieved the radiologic response, meaning improvement in radiologic findings attributable to their fungal infection and no need for continued antifungal use after treatment with TFF VORI in all six patients. With respect to safety, TFF VORI continues to maintain an attractive safety profile with no all-cause mortality or IPA-related mortality. There was one TFF VORI discontinuation after approximately just one week of therapy due to an unrelated adverse event of COVID infection that required intubation. Of note, following recovery from COVID and extubation, this patient's bronchoalveolar lavage test showed no further evidence of Aspergillus, and TFF VORI subsequently was not restarted. This patient was not included in the treatment response summary given the short duration of TFF VORI therapy. The majority of treatment-related adverse events, or TAEs, were deemed unrelated to TFF VORI, and the majority of TAEs were Grade 2 or lower in severity. There was no hepatic toxicity or visual disturbances. With respect to next steps for the TFF VORI program, our IND remains open in the U.S., and we have gained alignment with the FDA that TFF VORI's regulatory pathway can proceed as a 505(b)(2) drug candidate. As Harlan mentioned, we are looking to advance the TFF VORI program through potential partnerships or outlicensing or collaborations, as well as grants. We believe that a single phase 3 study will be sufficient for regulatory approval, and potential indications for TFF VORI include treatment or prevention of IPA and other voriconazole-responsive invasive pulmonary fungal infections, treatment of chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, aspergillus tracheobronchitis, aspergillus bronchoanastomotic infections, and the treatment or prevention of valley fever or coccidioidomycosis and other endemic fungal infections. In 2024, potential milestones include securing partnership for the program or additional nondilutive funding through collaborations or grants. I will now turn over the call back to Harlan for closing remarks. Harlan? Thank you, Zamaneh. After being appointed CEO of TFF Pharmaceuticals in February 2023, I made it a strategic mandate to advance our proprietary pipeline in order to build shareholder value. Furthermore, this mandate would be executed through a data-driven process to ensure that we could bring forward a truly differentiated, best-in-class therapy with the potential to significantly improve upon the existing standard of care. Our decision to prioritize TFF TAC is wholly consistent with this strategic mandate, and we hope today's update has provided you with a clear understanding and rationale for this important decision. In summary, all of us at TFF are moving forward with great energy to advance the TFF TAC program, which represents a unique opportunity to bring forward a new and highly innovative product in the field of transplant medicine. With that, we'll now be happy to take any questions. Operator? Thank you, ladies and gentlemen. We will now conduct the question-and-answer session. If you have a question, please press star one on your telephone keypad, and if you wish to cancel your request, please press star two. One moment for your first question. Your first question comes from Jonathan Aschoff from Roth MKM. Your line is now open. Thank you, and thanks for that extensive update. What is the phase 3 efficacy threshold for FDA approval for TFF TAC, and do you need to conduct a head-to-head trial? Hi, Jonathan. We believe that we will need to conduct an active comparative trial where we compare TFF TAC with oral tacrolimus. And in a general sense, in a broad sense, this threshold for FDA approval is always showing a meaningful improvement in safety and/or efficacy, and we believe there's plenty of room for improvement with oral tacrolimus in both fronts. We also believe that TFF TAC could differentiate on both safety and efficacy. As far as the specifics of the trial design, we will really need to wait until we've had the discussions with the FDA, and it will depend largely on the outcome of those discussions. Okay, but no guess as to the solid sense of the Phase 3 numerical efficacy threshold, correct? That's correct. Oral tacrolimus was approved after the FDA reviewed about 18,000 patients' worth of real-world data because people were using oral tacrolimus. So there was never a head-to-head comparison, for example, between oral tacrolimus and cyclosporine, the drug that it pretty much largely replaced. So that's why some of these discussions are discussions that we really need to have with the FDA and get alignment on the threshold that would be the right threshold. Okay, thank you. Do you need to prove reduced kidney tox in phase 3, or is just knowing that there's a 33% lower blood level with TFF TAC with the same efficacy, is that enough to imply that there would be lower kidney tox? There are a lot of ways to show improvement in kidney toxicity, potentially in a phase 3 or a phase 3 trial. You could show, for example, that fewer patients are developing chronic kidney disease, or you could show that fewer patients are developing, for example, Stage 3 chronic kidney disease, or you could show that there is a decrease in the rate of renal function deterioration, for example, as measured by GFR or creatinine. Overall, we believe that it's not enough to just show decreased systemic exposures. You have to show improvement one way or another on the kidney toxicity itself. What I can say, though, is that we have reviewed our data with many KOLs, and they agree with our prediction that if we were to lower systemic exposures by roughly 30%-50%, we are likely to see an impact on toxicities that are common with tacrolimus, including chronic kidney disease. Okay, and lastly, what is the TFF TAC commercial timing? Very, very broad strokes on commercial timing, but also the trial cost, and then thirdly, the current cash runway inclusive of the last capital raise. These are very good questions. I'm not sure if we're disclosing those in this update. Harlan, would you like to take this? Yeah, I think, as Zamaneh said, in terms of the clinical trial itself and what it's going to look like and its duration, I would say TBD now. As Zamaneh laid out, we have a general sense of what it should look like. We have clear ideas that we'll be presenting with regulatory authorities, and I think it's premature for us to add any more specificities about it until we have those interactions and our assumptions are confirmed. In terms of cash runway, we haven't in our financials, we haven't filed our 10-K yet, so we can't provide any precise number around our current cash or what our cash runway guidance is until we do our earnings release, which will happen later this month. But we're feeling good that Zamaneh will put together a program that can be executed by us and can result in approval and commercialization. Good enough. Thank you. Your next question comes from Justin Walsh from JonesTrading. Your line is now open. Hi, thanks for taking the questions. Congrats on the updated data here. Without giving anything away that's under embargo at the ISHLT meeting, can you provide some color on why you expect the biomarker data to be meaningful for TFF TAC? Sure. I guess to go back and think about what the gene expression data generally tell one, our body responds to injury, infection, changes in the environment, or various challenges by upregulating or downregulating the expression of different genes. So one can look at the patterns of gene expression and kind of work backwards from there to figure out the types of challenges the body is experiencing. Gene expression analysis and endobronchial biopsies help us really understand the challenges that the patient's lung transplant is facing, what challenges they were facing while they were on oral tacrolimus, and what challenges they're facing after having been on 12 weeks of treatment with TFF TAC. In particular, we're very interested in those genes whose expression either goes up or goes down in the setting of an acute rejection. So in the setting of an acute rejection, we would expect those particular genes and their certain patterns that are known to have abnormal levels of expression as opposed to when there is no acute rejection, when those levels normalize. Generally, you evaluate the data from gene expression in the context of all the other information you have. You put that all together. How is the patient doing in terms of signs and symptoms? How is their spirometry? Is there deterioration? How is the chest X-ray? Or if they have a chest CT, what is that showing? What medications have they needed? Have they needed any pulse steroids? What are the other biomarkers, perhaps? But also, in addition to that, having the opportunity to look at gene expression profile helps you have actionable results that you can integrate with everything else and decide what to do with the patient. So, for example, if you were to look at the gene expression profile and see that the rejection-related genes have normalized largely, then you feel comfortable to wean the immunosuppressant therapy that the patient is on, as opposed to if you see that there's more up or down regulation of those rejection-related genes, perhaps you would stop decreasing or you might increase the level of immunosuppressant therapy. So we think the data that will be presented will be very informative in really gaining a better understanding and a deeper understanding of the patient experience in the trial so far. Got it. One more question for me. You mentioned potentially seeking nondilutive funding for TFF VORI. I'm wondering if you can provide some color on where you think maybe an appropriate organization to apply for grants for that type of asset would be. I think I will turn that to Harlan as well. He's, I think, well, best suited to answer that. Yeah. Yeah, thanks for the question. The best I can do right now is tell you that we are having active discussions with funding organizations that are interested in fungal infections. I think your question was about TFF VORI. And there is a really disturbing increase in fungal infections across the globe. Some of that is due to the proliferation of immunosuppressive agents and cancers, bone marrow transplants, and so forth. So we're seeing more and more patients at risk of fungal infections and actually getting fungal infections. And that's attracted the attention of government organizations, for example, funding organizations. And the other is environmental, that there are endemic fungal infections that have been increasing, again, in a very disturbing way over the last couple of years, which many attribute to the changes in climate that we're seeing with a combination of wetter conditions and higher temperatures, which is increasing the rate of fungal infections. And again, not surprisingly, that has attracted the interest of, for example, government funding agencies. At this point, I can't be more specific of who we're talking to and what we're talking about because we're in early stages of those discussions, but I'm certainly hopeful that maybe one of these would come to fruition and would be a way of moving TFF VORI forward. Got it. Thanks. Your next question comes from Daniel Carlson from Tailwind Research. Your line is now open. Hey, guys. Thanks for taking my questions. Great data so far, so congrats on that. Quickly, just regarding slide 10 about TAC, how long until you can start the phase 2 trial, and what do you need to learn from this before you transition it to the global phase 3 that you alluded to? Hi, Dan. It's a good question. So what I can tell you is that we feel, at this point, with 8 patients having successfully transitioned from oral Tacrolimus to TFF TAC and having nearly 174 weeks of cumulative exposure duration and no signs of rejection at the reduced systemic exposures, we're ready to talk with the FDA and discuss our plans for the next phase 2 study. The current phase 2 study is a single-arm study, and it really provided us or has continued to provide us with proof of principle for TFF TAC, namely that you can take patients and transition them safely from oral tacrolimus to TFF TAC and maintain the lung transplant. But now we're ready to really examine the safety, tolerability, and efficacy of TFF TAC in a more formal way, in a comparative control phase 2 study where we put the drug against oral tacrolimus, and then from there, potentially seamlessly transition into a phase 3. We will know the final sample size after we've had our discussions with the FDA. So at this point, what we're thinking is that that phase 3 will have approximately 200 patients. If we're able to do that seamless transition from Phase 2 to Phase 3, then the sample size from the Phase 2 will contribute to the Phase 3 numbers. Okay. You just need to get more data for a number of patients in the Phase 2 to move to Phase 3. It's nothing that you're looking for in particular. That answers my last question. The 200 patients is the combined of the two, hopefully. That's right. Okay. Okay. Another question about Voriconazole. The data look great, but I understand you're prioritizing TAC. Is that because of the funding constraints of the company, or is it because that VORI is being used in more of a prophylactic setting, which you don't have any data on and is a longer, more difficult trial? I think maybe Harlan. Strategically, yeah. Yeah. Thanks. Go ahead, Harlan. Dan, thank you. Thanks for the question. Well, as we've said, our decision to prioritize TFF TAC was not because of any issues related to TFF VORI. While it's true that we don't have data in the prophylaxis setting, I don't have doubts that TFF VORI could be successfully developed in this indication. As you sort of implied, for any company, there's a constant need to prioritize and optimize allocation of capital in a way that maximizes shareholder value. The reality is that for a small company like ours, with limits on what we can afford, we made the decision that we could reasonably bring forward only one of the programs. It was a difficult decision. However, we made it based on a few factors that I mentioned earlier in the call. First, it was based on the highly encouraging data that Zamaneh presented to you on the TFF TAC phase 2 trial. That makes us confident that TFF TAC represents a truly innovative new therapy, which has the potential to make a difference in the lives of lung transplant patients. Driving innovation forward, I think, is always an important part of value proposition for a product. Second, as you've heard today, we've had a really high level of physician interest and enthusiasm expressed to us from transplant physicians, and that reinforces our belief in moving that product forward. Another important consideration for us was looking at the earlier value inflection points that we'd likely see in the TFF program compared to what we would have seen in a prophylaxis program for TFF VORI. Achieving those inflection points is important to us, and we know it's important to investors. Finally, our recent assessment of the total market opportunity for TFF TAC turns out to be very large, larger than we had initially thought. We estimate now that it could be well over $2 billion in peak annual sales. So pragmatically, it seemed like the right decision to go forward and with a really great commercial opportunity. So stated simply, we believe that TFF TAC can create significant value for patients, for the physicians who treat them, and for the investors who are supporting the product in our clinical development. Thanks, Harlan. Can I just follow up with one question about the TAC trial? Based on the excitement for the key opinion leaders in this space around what you're doing, it's taken a long time to get the eight patients. But as you move forward, do you have any sense on are we looking at a multi-year trial, or what's a realistic timeframe that we should be modeling for the completion of the phase 2 and 3? That's a really good question. Yeah. Yeah. No, that's a very good question. So we started the trial in Australia, and there are a limited number of sites, actually, centers that do a significant number of lung transplants in Australia. So by bringing this study to the U.S., that will make a huge difference. There are, I believe, close to 80+ centers. Many centers perform north of 50, close to 75, 100 lung transplants per year. So lots of centers, lots of large-volume centers, and lots of enthusiasm. Also, always, it's hard at the beginning when you don't have that safety and signal of efficacy data. The first investigator that participates in this study believes in the hypothesis, so gives it a try but does it very cautiously, and especially in lung transplant patients. Now we see that as our investigators are bringing patients in, they are feeling more comfortable. They're weaning patients' dose of TFF TAC faster. They're developing that sense of predictability that comes with working with a drug. I think it's a great question, but really, the enrollment to date, I think, has to be taken in the context of very early trials where the very first experiences in patients are evolving, emerging, and also the limitation in the number of centers in Australia. We've been very grateful to our investigators in Australia and grateful to the patients who have participated in this study so far. We're also grateful to see that they all want to stay. The 4 out of 4 patients who've completed Part A, they didn't want to go back on oral tacrolimus. They wanted to stay on TFF TAC. So we're very excited about the data, and we think that the enrollment will be different in the next phase 2 study in the U.S. Thanks, Zamaneh. That's a very helpful answer. I appreciate it. And if I could just ask one more follow-up on that. As an investor here, when you look at this trial, I mean, one is inhaled and one is oral, the standard of care. Will this be a placebo, a double-blind trial, or is it going to be open-label, and will we get updates as we go along, in your estimation, as a designer? Yes. Yes. No, that's a good question too. It's very difficult to blind a type of drug like tacrolimus in general because tacrolimus is very much an individually dosed drug. It's not like when you have, say, an ear infection and you might go on Augmentin, an antibiotic, and it's the same dose no matter who the patient is. As long as it's an adult, it's the same dose. That's not tacrolimus. Tacrolimus is very much individually dosed. Not only that, tacrolimus has drug-drug interactions with a lot of other drugs that patients could be on or may need to be on. You would have to then adjust the dose of tacrolimus up and down depending on what else the patient is on. So it would be very difficult from a safety perspective to ensure patient safety if this study was blinded and the physician didn't know, "Am I adjusting an oral dose, or am I adjusting an inhaled dose?" So from that perspective, the study will have to be an open-label study, but it will be a comparative control. And generally, in studies like these, you implement enough blinding such that only people who need to know the data are exposed to the data. So you control sort of exposure to the data that way as the trial goes on. We expect periodic data releases potentially along the way just so that we're informed and the community is informed of their progress. Excellent. Thanks for another great answer, and thank you both for your efforts turning this around. Great job. Thanks. Thank you. There are no further questions at this time. Sir Harlan Weisman, please proceed with your closing remarks. Thank you. Well, I'd like to thank all of you for joining us today. We believe the data being generated in our ongoing Phase 2 study shows that TFF TAC has a unique, differentiated profile that could improve upon how immunosuppression therapy is delivered within the lung transplant setting. We look forward to updating you on additional progress for the TFF TAC program throughout 2024. Please don't hesitate to reach out if you have any additional questions. Ladies and gentlemen, this concludes today's conference call. Thank you for joining. 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