Good morning, ladies and gentlemen, and welcome to the TFF Pharmaceuticals, TFF VORI, and TFF TAC program update conference call. As a reminder, this conference is being recorded. I'll now turn the call over to your host, Corey Davis of LifeSci Advisors. Thank you. You may begin. Thank you, operator. Hello, everyone, and welcome to TFF Pharmaceuticals, TFF VORI, and TFF TAC program update conference call. With me on the line this morning is Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals, Dr. Zamaneh Mikhak, Chief Medical Officer, and Kirk Coleman, Chief Financial Officer. Before we get started, I'd like to remind everyone that this call will contain forward-looking statements, including, without limitation, statements about including the advancement of TFF VORI and TFF TAC 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 this morning concerning the initial data for TFF VORI and TFF TAC. Now, it's my pleasure to turn the call over to Dr. Harlan Weisman. Go ahead, Harlan. Thank you, Corey, and good morning, everyone. Thank you for joining us for our TFF VORI and TFF TAC program update conference call. With me on today's call is our Chief Medical Officer, Dr. Zamaneh Mikhak, and our Chief Financial Officer, Kirk Coleman. Today, we are very pleased to share with you the initial clinical data from our two clinical programs with TFF VORI and TFF TAC. At the beginning of the year, when I was first appointed CEO of TFF, I explained to investors why I was so excited to lead this unique and innovative company. Through our clinical stage TFF VORI and TFF TAC programs, we had the opportunity to address two rare diseases with significant unmet need. In the months that followed, we put in place the right people and resources to make considerable progress over the last few months, and today I'm pleased to share with you the first set of data from our two clinical programs. Based on these initial data, I can say unequivocally that my enthusiasm has only continued to grow for these two programs. To briefly summarize, TFF VORI and TFF TAC are acting exactly how we had hoped, each product delivering drug in a highly targeted manner into the lung, demonstrating efficacy and favorable safety and tolerability. As both a physician and drug developer, I can tell you that there is no greater satisfaction than to see technological promise translate into clinical benefit, particularly as it relates to the treatment of rare disease, where patients have limited treatment options. This not only bodes well for the advancement of these two programs, but also serves to clinically validate our company's technology platform. In my view, we are only just starting to realize the full potential of thin film freezing to transform both new and existing drugs to effect improved treatment outcomes for patients across multiple disease areas. To provide more granularity on these exciting clinical results, I'd like to now turn the call over to our Chief Medical Officer, Dr. Mikhak, who will review the initial patient data and treatment outcomes for our two clinical programs, the ongoing phase II study and expanded access program for TFF VORI and the ongoing phase II study for TFF TAC. Zamaneh? Thank you, Harlan. It's my pleasure to review with you today the initial data from our two clinical programs, beginning with TFF VORI. By way of background, TFF VORI is being developed 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. The most common toxicities associated with voriconazole resulting in its discontinuation include liver toxicity, visual disturbances, and rashes. Other potential serious toxicities are arrhythmias, QT prolongation, and photosensitivity. Drug-drug interactions represent another significant limitation of oral and intravenous voriconazole. Voriconazole can increase or decrease the levels of other drugs needed for the treatment of a patient's underlying illness, such as chemotherapeutic or immunosuppressive agents, driving these drugs to subtherapeutic or toxic levels. Not surprisingly, the high rates of toxicities and drug-drug interactions lead to a poor prognosis. 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 ongoing phase II trial is a randomized, open-label study evaluating TFF VORI versus oral voriconazole. The duration of treatment is 13 week, and the trial endpoints include safety and tolerability, clinical, radiologic, and mycologic responses, as well as all-cause mortality. The parameters that establish the disease status at baseline, such as evidence of infection, signs and symptoms, lung function, and lung structural abnormalities, form the endpoints of this study. Treatment response is assessed by mycologic response, defined as clearance of the Aspergillus 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. Once through the screening process, patients enter the treatment period of the trial and are randomized in a three to one ratio to receive either 80 mg of TFF VORI twice daily or 200 mg oral voriconazole twice daily. Patients are followed closely for emergence of adverse events, including all-cause mortality, to assess safety and tolerability. In addition, clinical assessments are conducted throughout the 13-week treatment period for signs and symptoms, lung function, and galactomannan and Aspergillus biomarker. Chest CT is repeated at eight weeks and 13 weeks of treatment to detect improvement in lung structural abnormalities. In addition to presenting initial data from our phase II study, today we will present data from patients enrolled in our Expanded Access Program or EAP. As a reminder, we launched our EAP in July in partnership with Durbin to provide access to TFF VORI for patients in need who do not qualify for our ongoing phase II study. The EAP provides 12 week 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 last spring, and the EAP remains open in the U.S., Canada, Australia, the U.K., and select E.U. countries. As noted on our third quarter conference call, given the considerable amount of historical safety and efficacy data of voriconazole in IPA, we had anticipated that data from approximately 10 patients would be sufficient to guide a phase III Go/No-Go decision. Today, we are sharing the initial data from a subset of these patients. Based on these highly encouraging results, we have made the decision to accelerate the development of TFF VORI into registration-enabling studies. As a reminder, we define success as TFF VORI being effective as an antifungal in a majority of patients with a better overall safety and tolerability profile compared to oral or intravenous voriconazole. To evaluate efficacy, we assess three types of responses: clinical, radiologic, and mycologic. Clinical response is defined as an improvement in signs and symptoms and/or lung function measures such as forced expiratory volume one, or FEV1, via spirometry. Mycologic response is defined as no evidence of Aspergillus in the assays performed post-treatment. For example, a decreased or non-detectable galactomannan. Radiologic response is defined as an improvement in the abnormal findings on chest CT, such as the number and/or size of nodules or spots or cavities, et c. With respect to safety and tolerability, we assess all-cause mortality, treatment-emergent adverse events, including common known voriconazole toxicities and treatment discontinuations. I will start by reviewing a summary of our results. We will then delve into the data in detail in subsequent slides. To summarize our findings with respect to efficacy, of the five patients treated with TFF VORI for at least eight weeks, all five patients achieved a clinical response, again defined as improvement in signs, symptoms, and/or spirometry. All five achieved a mycologic response, defined as no evidence of Aspergillus in the assays performed post-treatment. Four patients had baseline and follow-up chest CT. Three out of four patients achieved a radiologic response. Very importantly, there was no need for continued antifungal use after treatment with TFF VORI in all five patients. To summarize our findings with respect to safety, bearing in mind the 30% 12-week mortality rate observed for patients with IPA, there was no all-cause mortality or IPA-related mortality in the seven patients treated with TFF VORI. There were no TFF VORI discontinuations due to an adverse event. The majority of TAEs were grade two or lower in severity, and the majority of TAEs were deemed unrelated to TFF VORI. Finally, there was no hepatic toxicity or visual disturbances in patients treated with TFF VORI. Again, these being the two most common adverse events associated with discontinuing oral therapy. The next slide provides an overview of patient baseline characteristics and demographics. I should mention that the data presented today is a snapshot of the data available as of 11/17/2023. Since the study is still ongoing and the database still open, the data may be subject to change. As the second column from the left indicates, in the phase II trial, two patients received the oral formulation of voriconazole, while three patients received TFF VORI. Additionally, four patients had received TFF VORI through our EAP. Today, we will be presenting safety data from all patients. We will be presenting efficacy data from those patients who received at least eight weeks of treatment. The time points when chest CT and mycologic tests were repeated, thus enabling the assessment of radiologic and mycologic response. You can see treatment durations in the second column from the right. As indicated in red, one of the two patients who received oral voriconazole died after four weeks of treatment. This patient will be discussed in the context of the safety summary. The other oral patient received 13 weeks of treatment and will be described in the efficacy summary. Five of the seven patients treated with TF40 were treated for at least eight weeks, ranging from eight to 24 weeks, and will be described in the efficacy summary. Importantly, it's worth mentioning that three of the five TF40 patients included in the efficacy summary suffered from CLAD, or chronic lung allograft dysfunction. CLAD is a lung disease caused by chronic rejection, where the patient's immune system chronically attacks the transplanted lung. CLAD is the leading cause of death in lung transplant recipients, and lung infections can exacerbate the signs and symptoms associated with CLAD. Therefore, three out of five patients treated with TF40 and included in the efficacy summary were more clinically challenging compared to the oral patient who did not have CLAD. This provides important context as we assess treatment response. The next slide summarizes the efficacy assessment for the patients who completed at least eight weeks of therapy. As the table indicates, all the patients treated with TF40 experienced across the board improvements in clinical, mycologic, and or radiologic responses. We have clinical response, defined as improvement in signs and symptoms or spirometry in five out of five TF40 patients. One patient, labeled as TFF VORI-two, experienced improvement in spirometry but has not yet had improvements in signs and symptoms. However, the patient has four more weeks of treatment remaining. We have mycologic response, defined as no evidence of Aspergillus in the assays performed post-treatment in five out of five TFF VORI patients. We have radiologic response, defined as improvement in abnormal IPA-related radiologic findings in three out of four TFF VORI patients with pre- and post-treatment chest CTs. The treating physician chose not to repeat the chest CT in TFF VORI-six patient, who was doing well and was enrolled as part of the EAP. I'd now like to walk through the individual patient response data. As shown on this next slide, patient 1, who received oral voriconazole, designated as Oral-1, was a 45-year-old female lung transplant recipient who presented with moderate respiratory insufficiency and bronchoalveolar lavage, or BAL, evidence of Aspergillus. After 13 weeks of treatment with oral voriconazole, the patient demonstrated a clinical, mycologic, and radiologic response. Although total symptom scores varied over the treatment period, we saw a decline in total symptom scores from two at screening to zero at the end of treatment at week 13. In addition, the patient's serum galactomannan and blood PCR for Aspergillus were negative at week 13. The graph at the bottom of this slide indicates that the patient's lung function, as represented by FEV1, started at approximately 65% normal and improved over the treatment period by approximately 14%. As we will discuss later, compared to the patients who presented with CLAD and received TF40, this patient started at a relatively healthier baseline lung function. The next slide shows the radiologic images for this oral patient at baseline and after 13 weeks of treatment. In the image on the left, which represents baseline, the top red arrow points to a bronchus that has a very narrow opening due to bronchial wall thickening or swelling. This bronchus is not able to provide normal amount of air to the area of the lung shown by the two lower arrows, thus the haziness in that area and the 65% normal lung function in this patient. As you can see in the image on the right, after 13 weeks of treatment, the bronchial wall thickening has resolved. The bronchus has a wider opening now, and there is good aeration in the area supported by the bronchus and designated by the red circle. By contrast to the case we just reviewed, the first patient who received TFF VORI, designated as TFF VORI-one, was a 58-year-old female lung transplant recipient with a history of CLAD, who presented with mild fever and hemoptysis, which is coughing up blood, and moderate pleuritic chest pain, pleuritic rub, and respiratory insufficiency. As you can see from her starting total symptom score of eight, this patient was more ill than the oral patient, who started with a total score of two. In fact, this patient's baseline lung function was alarmingly low, with an FEV1 of just under 20% normal, as opposed to 65% normal for the oral patient. After 13 weeks of treatment with TFR40, this patient demonstrated a clinical, mycologic, and radiologic response. The patient's total symptom score improved from eight at screening to three at the end of treatment at week 13. In addition, the patient's serum galactomannan and blood PCR for Aspergillus were negative at week 13. As shown in the graph at the bottom of this slide, patient's lung function trended up for the first four weeks of treatment with TFF VORI until the patient experienced two serious adverse events of presumed bacterial respiratory infections unrelated to TFF VORI or patient's IPA at week four and week eight. Since lung transplant patients develop infections frequently based on the need to take immunosuppressive therapy to prevent rejection, the unrelated respiratory infections were not altogether surprising. The patient's baseline CT scan to the left shows an Aspergillus nodule, as indicated by the red arrow. The CT scan on the right shows complete resolution of the Aspergillus nodule at 13 weeks of treatment with TFF VORI. On this slide, we show the treatment outcome thus far for the second patient treated with TFF VORI from our phase II trial. TFF VORI-102 is a 51-year-old white male, lung transplant recipient who presented with mild respiratory insufficiency. This patient had not completed 13 weeks of treatment. As you can see on the graph, the patient's baseline lung function was approximately 30% normal, which is very low despite relatively mild symptoms. After eight weeks of treatment with TFF VORI, the patient demonstrated a clinical, mycologic, and radiologic response. Although the patient's mild respiratory insufficiency has not improved yet, the patient's FEV1 improved from 29% to 47% after eight weeks of treatment with TFF VORI, which represents a 60% improvement. In addition, the patient's serum galactomannan blood PCR for Aspergillus were negative at week eight. As shown on the next slide, the Aspergillus nodule, designated by the red arrow in the baseline CT image on the left, is no longer present after eight weeks of treatment with TFR40 in the CT image on the right. We will now discuss a patient who was treated through our expanded access program. TFF VORI-four was a 50-year-old white male, lung transplant recipient who presented with moderate cough, shortness of breath, and respiratory insufficiency. Patient had a history of CLAD and BAL evidence of Scedosporium, which is a type of fungal infection that is voriconazole responsive and Lomentospora. As shown in the graph on the left, this patient was experiencing rapid deterioration in lung function over the past six months due to recurrent pulmonary fungal infections and worsening CLAD, and came in with a baseline FEV1 of 40% normal. After 20 weeks of treatment with TFF VORI, the patient demonstrated a clinical, mycologic, and radiologic response. His total symptom score improved from six at baseline to three, and very importantly, his lung function stabilized, which is significant given patient's history of CLAD and BAL cultures negative for Scedosporium. The next slide shows CT images of the patient's lungs at baseline on the left and after treatment with TFF VORI on the right. Areas of infection are indicated by red arrows. As you can see, the infection has cleared after approximately 12 weeks of treatment with TFF VORI. I think it's important to also mention that treatment with TFF VORI was safe and well-tolerated over this extended treatment period, as patient reported no adverse events, providing clinical evidence that TFF VORI can be administered over long periods of time. The next EAP patient, TFF VORI -five, was a 54-year-old white female, lung transplant recipient who presented with moderate cough and shortness of breath, history of CLAD, and BAL evidence of Aspergillus infection. Following 12 weeks of treatment with TFF VORI, the patient's total symptom score improved from four to two, with lung functions remaining stable. Patient demonstrated a mycologic response as BAL Aspergillus culture and PCR and galactomannan were negative following TFF VORI treatment. A single pre-existing nodule on chest CT did not improve following treatment. It is important to note that this particular patient had a history of developing new Aspergillus lung infections every two to three months. But following 12 weeks of therapy with TFF VORI, the patient has not had a new infection with Aspergillus in over 1 year, which is a remarkable result considering her prior medical history. The next EAP patient, TFF VORI six, was a 59-year-old white female lung transplant recipient who presented with mild cough and shortness of breath and BAL evidence of Aspergillus infection. After 12 weeks of treatment with TFF VORI, the patient's total symptom score improved from two to one. Her lung function remained stable, and her BAL Aspergillus culture, microscopy, and galactomannan became negative. Based on the patient's improved overall symptoms and negative Aspergillus test, the treating physician determined that a follow-up radiologic assessment was not necessary, which I believe speaks to the favorable clinical outcome in this patient. The next few slides provide a summary of treatment responses in patients who received at least eight weeks of treatment. Starting with clinical signs and symptoms, improvement in signs and symptoms were observed for the four patients treated with TFF VORI for 12 weeks or more. Treatment with TFF VORI clearly led to meaningful improvements, which is particularly impressive considering that three of the five TFF VORI patients presented with a history of CLAD. With respect to spirometry, as you can see in this chart, FEV1 scores either stabilized, remained stable, or improved for all patients treated with TFF VORI. TFF VORI-one, with a history of CLAD and severe lung dysfunction at baseline, represented with the orange line, improved in the first four weeks of therapy and then declined following two presumed bacterial respiratory infections, which likely developed due to the patient's immunocompromised state. The next slide summarizes the mycologic assessments performed. All patients presented with BAL evidence of aspergillosis. Post-treatment mycologic evaluation was negative in all five patients treated with TFF VORI for at least eight weeks. As you can see, mycologic assessment was done in the blood in some patients and in the BAL in others, reflecting differences in regional medical practices, as some physicians prefer not to put the patient through a repeat BAL, a procedure that requires anesthesia if patient is doing clinically well. Instead, blood is tested as a non-invasive mode of follow-up. The next slide summarizes the radiologic assessments. Three of the four patients treated with TFF VORI for at least eight weeks with pre and post-treatment radiologic evaluation showed resolution of their aspergillosis abnormalities, which included two patients treated with TFF VORI who had previously been diagnosed with CLAD. After 12 weeks of treatment with TFF VORI, 1 EAP patient with a pre-existing nodule did not show a radiologic response, while another EAP patient was not assessed. This slide provides a high-level summary of the efficacy assessments. As the table indicates, all the patients treated with TFF VORI experienced across-the-board improvements in clinical, mycologic, and/or radiologic responses. We are very encouraged by these results, which suggest that TFF VORI is an effective antifungal. The next slide shows the safety data for the two patients treated with oral voriconazole and the seven patients treated with TFF VORI. Bearing in mind that these are small patient numbers, we can still see a clear separation in the safety and tolerability between oral voriconazole and TFF VORI. There were 13 TAEs for two patients who received oral voriconazole, compared to 14 TAEs for seven patients who received TFF VORI. 50% of TAEs in the oral voriconazole group were deemed possibly or probably related, versus 29% in the TFF VORI group. 50% of patients experienced a grade three or above TAE in the oral voriconazole group, compared to 14% in the TFF VORI group. As mentioned previously, one patient who received oral voriconazole died, thus discontinued treatment due to AE. While there were no deaths or treatment discontinuations in the TFF VORI arm, no patient experienced bronchospasm or wheezing with TFF VORI. Finally, I think it's also very important to note the bottom two rows on this table, which speak to the safety differences between the two treatment arms. Two top reasons for discontinuing oral voriconazole are visual disturbances and hepatic toxicities. Not surprisingly, we saw both adverse events appear in the patient treated with oral voriconazole that did not die.... Remarkably, however, we saw no cases of either visual disturbances or liver toxicity in patients receiving TFF VORI, which included a much larger number of patients compared to the oral voriconazole arm. The cumulative observations to date strongly suggest that TFF VORI offers a significantly more attractive safety and tolerability profile compared to the oral formulation. I'd now like to discuss the initial data from our ongoing phase II study of TFF TAC. As a reminder, TFF TAC aims to address a significant unmet medical need in lung transplantation. Patients receiving a lung transplant have an expected 5-years mortality rate of approximately 50% due to oral tacrolimus' 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 to introduce a therapy such as TFF TAC with the potential to improve upon the current standard of care. Our ongoing phase II 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-weeks treatment period, and Part B is an optional safety expansion period. Prior to receiving treatment, patients enter a two weeks 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 tacrolimus blood levels that are approximately 2/3 to 1/2 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. Given the significant amount of historical patient safety and efficacy data from oral tacrolimus, we had anticipated that data from approximately 10 patients would be sufficient to guide a phase III go/no-go decision. Today, we will be sharing initial data from a subset of these patients. Like TFF VORI, based on highly encouraging results, we have made the decision to accelerate the development of TFF TAC into registration-enabling studies. As a reminder, we define success by the ability to transition patients from oral tacrolimus to TFF TAC, achieving tacrolimus blood levels that are approximately 2/3-1/2 of the patient's blood levels on oral tacrolimus, preventing rejection at these diminished tacrolimus blood levels, and stabilizing kidney function. To assess efficacy, the ongoing phase II study follows patients for signs and symptoms suggestive of acute rejection, the need for pulse corticosteroids, deterioration in spirometry, and deterioration in lung imaging. With respect to safety and tolerability, we assess TAE, treatment discontinuation, continuation to Part B of the trial, the long-term expansion, and kidney function. Four patients have been enrolled in the phase II study of TFF TAC to date. To summarize the results for TFF TAC, we were able to successfully transition four out of four patients from oral tacrolimus to TFF TAC and lower tacrolimus blood levels to 1/2 to 2/3 of the oral level. We saw no clinical evidence of acute rejection, including no signs and symptoms suggestive of acute rejection, no use of pulse corticosteroids, no deterioration in spirometry, and no chest X-ray findings suggestive of acute rejection. Three out of three patients who completed Part A chose to remain on TFF TAC and have proceeded to Part B of the trial. With respect to safety, there were no patient deaths, no TFF TAC discontinuations due to an AE. The majority of TAEs were grade two or lower in severity, and kidney function was maintained. You see the baseline characteristics and demographic data for the four patients enrolled in the TFF TAC study. I should mention that the data presented today on TFF TAC is a snapshot of the available data as of 11/29/2023. Since the study is still ongoing and the database still open, the data may be subject to change. As you can see, the patients are in their sixties and seventies. They are three to nine years since lung transplant and have had renal insufficiency for two and a half to six year s. There's no history of CLAD. Three of the four patients have completed 12 weeks of treatment with TFF TAC. All three have chosen to remain on TFF TAC and have proceeded to Part B of the study. This table shows the transition of patients from a stable dose of oral tacrolimus to a stable dose of TFF TAC and tacrolimus blood levels associated with each dose. As you can see, Patient 1 was on 5 mg of oral tacrolimus and was successfully transitioned to 0.75 mg of TFF TAC, about 1/7 of the oral dose, decreasing tacrolimus blood levels to approximately 1/2 of the oral level. Patient 2 was on 1 milligram of oral tacrolimus and successfully transitioned to 0.25 mg of TFF TAC, 1/4 of the oral dose, decreasing tacrolimus blood levels to approximately 2/3 of the oral level. Patient three was on 5.5 mg of oral tacrolimus and successfully transitioned to 0.5 mg of TFF TAC, one-eleventh of the oral dose, decreasing tacrolimus blood levels to approximately 1/2 of the level on the oral drug. Finally, patient four was on 2 mg of oral tacrolimus and successfully transitioned to 0.25 mg of TFF TAC, 1/8 of the oral dose, decreasing tacrolimus blood levels by approximately 1/2 of the oral level. This patient is still early in treatment, and the TFF TAC dose may require further adjustment. Despite the decrease in tacrolimus blood levels on TFF TAC to 1/2 or 2/3 of the level on oral tacrolimus, patients have shown no clinical signs and symptoms suggestive of acute rejection, no deterioration in spirometry, no chest X-ray findings suggestive of acute rejection, and no need for pulsed corticosteroids. As previously discussed, three of the three patients who completed part A chose to remain on TFF TAC and have proceeded to Part B of the trial. Biomarker assessment of rejection is pending. As shown on this next slide, lung function measurements such as FEV1 have remained stable in all four patients. This slide focuses on kidney function, which is measured using creatinine or glomerular filtration rate or GFR. The higher the level of creatinine, the lower are the levels of GFR. As you can see, although there are some fluctuations along the way, creatinine and GFR levels remain largely stable in these patients who have had renal insufficiency for many years, ranging from two and a half to six years, long enough to potentially have irreversible kidney damage. This slide summarizes the safety data on the four patients enrolled in the TFF TAC phase II study. Overall, the safety profile seen with TFF TAC was compatible with the safety profile of tacrolimus. One patient experienced a serious adverse event of viral respiratory tract infection, which is expected in patients treated with immunosuppressive agents. One patient developed a transient worsening in renal function, presumed to be related to transient dehydration. One patient experienced hand tremor, which resolved after dose reduction on day four. No patient developed bronchospasm or wheezing. This concludes my remarks on the TFF TAC program. I'll now turn the call back over to Harlan. Harlan? Thank you so much for that comprehensive data presentation, Zamaneh. Hopefully, today's data presentation has provided you with real-world clinical evidence for why we are so excited to continue advancing these two programs, each of which is addressing a significant unmet medical need in rare disease. Today's presentation provides us with a wealth of data that strongly suggests that our two product candidates are working as intended, not only efficiently delivering efficacious amounts of drug into their targeted tissues, but doing so in such a manner that that significantly improves the overall safety and tolerability compared to the oral formulations of each drug. Importantly, both TFF VORI and TFF TAC represent potentially life-saving therapies where there are so few, if any, treatment alternatives for patients suffering from these two rare diseases. As I said in my opening remarks, these initial results demonstrate how the promise of our technology platform, Thin Film Freezing, is translating into meaningful clinical benefit for patients.... We plan to present additional data from these two studies in the first quarter of 2024, and based upon the cumulative results, we intend to engage the FDA on possible next steps for launching registration-enabling trials. I'd now like to turn the call over to the operator, so we can take questions from the audience. 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. Our first question comes from the line of Jonathan Aschoff with Roth MKM. Please proceed with your question. Thank you, and good morning, everybody. Great data for sure. Lots of detail. That was helpful. You know, how many more patients do you need for each program before you can request an end-of-phase II meeting? You previously said ten. You know, today you gave some data with more coming in the first quarter. So is ten still the case, and thus, can you proceed, you know, straight to an FDA meeting after the next update? Hi, Jonathan. Good morning, Jonathan, and, yeah, I'm gonna, I'm gonna let Zamaneh jump in, but I'm gonna let Zamaneh field that question, probably, the other questions that you have. Thanks, Jonathan, for the question. We believe we have enough data to start to engage the FDA. We believe it's helpful and important to engage the FDA early and often. We'll have additional data by the end of first quarter, and that certainly will be helpful for the package that we have. And the FDA interaction that we'll have can be in the form of an end-of-phase II meeting or any other type of meeting. It's just important to get feedback. And yes, we think that we have enough data to start that conversation. Okay, so you will engage, and then subsequent to that, release more data next quarter. So the- Um- -drop in dose, because that's what you just said, correct? I'm sorry. I wanna clarify. We probably will engage after the first quarter. Thank you. We have enough data already, but it takes a while to prepare the briefing documents, to request a meeting, to actually get feedback. So most likely, logistically, feedback and interactions will be after the first quarter. But in terms of how much data we need, we feel that we already have enough data, and certainly the additional data from the first quarter would be helpful as well. Okay. Thank you. You know, the drop in dose for each of the TAC patients was, you know, a lot, but have you actually followed these patients long enough to know for sure that you would have seen graft rejection if it was going to occur in those patients? Yes. We believe the amount of time these patients are followed is sufficient to have shown clinical evidence of acute rejection, which we have not seen. Okay, thanks. You know, the dose of TAC was, you know, like, about a quarter to an eleventh of the oral TAC dose, yet the blood levels of TFF TAC was like you were saying, 2/3, and in most cases, half of that that was seen with oral TAC. So why are the decreases in blood levels, you know, not more proportional to the decreases in TFF TAC dose? That's a good question. How much absorption you get for a particular chemical entity into the bloodstream from the lung is really dictated by the physical chemical properties of the compound. What we know is that it's a good thing that we get absorption of TFF TAC into the bloodstream because you need immunosuppression not only in the lung, but also you need immunosuppression systemically. So if TFF TAC was such that you didn't get any absorption into the bloodstream, that would not be helpful for the drug. So it is a good thing that we get levels of systemic exposure so that we make sure the T cells that are circulating in the bloodstream and could eventually home to the lung and cause rejection, those are also suppressed by the systemic levels. The main question is- Yeah ... how much, tacrolimus do you have in the lung and how much do you have in the blood, and what's the r-ratio of the lung to the blood levels? With TFF TAC, we flip the ratio such that for any 1 ng per ml of tacrolimus you have in the bloodstream, you have more tacrolimus in the lung compared to the bloodstream, where you need it most, where the transplanted organ is and where most of the rejection is happening. It's that flipping of the ratio such that you have immunosuppression more where you need it more, is where we think we can, potentially see the differentiated efficacy for TFF TAC. Okay. Thank you. You know, would a pivotal TAC program be designed such that, you know, you would be indicated specifically for transplant patients with reduced kidney function only? Would that kind of be the specific label or more broad? We're still working through that. That certainly is one possible label. One could argue that if you have a product that could help patients and has a differentiated, potentially differentiated efficacy and safety and tolerability. Why wait until patients develop toxicities and then put them on the product? Why not put them on the drug earlier to benefit from the potentially better efficacy, safety, and tolerability all along, and therefore improve clinical outcomes in general, especially when you're dealing with a disease that has a 50% mortality in five years? So we're working through all of that. That's certainly one strategy to focus on patients with renal toxicity or other toxicities, or potentially really off, offer the drug earlier and look for better outcomes in general. Okay, and lastly, you know, maybe for Harlan and Kirk in particular, you know, what will be the cost of running your own pivotal programs? Sounds like that's what you wish to do. I mean, that's what I'm hearing. You know, and how does that jive with your current cash balance? Yeah, let me take the first part, and I'll let Kirk weigh in as well. We're still working through the budgetary needs for this. Zamaneh and her team have been busy working with our manufacturing team to work out the details of both timelines and budget for phase III programs for both TFF TAC and TFF VORI. Kirk, do you want to comment on where we are financially? Yes, sir. We obviously haven't reported Q4 yet, but at the end of Q3, we reported we had approximately $9.7 million in cash. Our guidance at that time was that we had enough cash to fund operations into the second quarter of 2024. Our official guidance hadn't, hasn't changed, but clearly, we'll need to evaluate all the options as we move forward to be in the best position possible to extend the runway now that we have these exciting new data in hand. Thank you very much, guys. That is it from- Thank you, Jonathan. Thank you. As a reminder, if you'd like to join the question queue, please press star one on your telephone keypad. Our next question comes from the line of Justin Walsh with Jones Trading. Please proceed with your question. Hi, thanks for taking the questions. I guess the first one is, I'm wondering if you can share some initial thoughts on potential pivotal trial designs. I know that this will certainly be informed by your engagement with the FDA, but what are you thinking in terms of patient numbers, just from what you've seen so far? And related to that, I'm curious if you have thoughts on your ability to accelerate enrollment for these pivotal trials, compared to the phase II trials that you guys are presenting on. Yeah. Good morning, Justin, and thanks for the question. And again, I'm going to turn it over to Zamaneh to answer it. Hi, Justin. So we definitely have design ideas in mind for pivotal or phase III trials for both programs. We're engaging subject matter experts, key opinion leaders. We're holding ad boards in the first quarter of 2024 to really get feedback on the potential variety of designs. We're really looking to accelerate the programs. We're developing drugs that the chemical entity for each drug is a known entity. So with the 505(b)(2) pathway, there is opportunity for potentially benefit from the available safety, tolerability, and efficacy data and expedite the program. So we're looking into all of those. Until we have had FDA interaction, obviously, we wouldn't know what the final design will be, but we think at this point that for each program will be a single phase III or pivotal study, and the number of patients shouldn't be more than just about 200 or so. So that's, those are our assumptions at this point. And what was your- Got it. The second part of your question? That was, I was asking about just for strategies on accelerating enrollment. So- Yeah ... presumably more trial sites, but just curious about that, maybe engagement with physicians or what initial thinking on that would be. Yes. Yes, and that's a very good question. So, enrolling in a phase III trial is generally faster than enrolling in a phase II trial, especially when the phase II trial is in the early stages of development, as you bring in the first wave of patients. By virtue of having generated data, that by itself really facilitates investigators feeling comfortable with approaching patients and enrolling them. That's, you know, one aspect because you have data now, where at some point you didn't have data. The other aspect is that in a phase III trial, you, your eligibility criteria in general is much broader. For example, in our current trial, for hematologic malignancy patients, we require that they do not have, they're not undergoing actively chemotherapy or radiation therapy. or for hematologic malignancy patients, they're after induction therapy, while in a phase III trial, for example, you would not have necessarily those restrictions because those are the periods, for example, that patients with malignancy are most vulnerable to Aspergillus infection. So these types of changes in the eligibility criteria will help broaden access to the trial and help enrollment. Got it. Thanks. A couple more. I'm wondering if maybe you could just sort of comment on the, just the expected trajectory of, kidney function for, for these patients, the TFF TAC patients, if they had, remained on the, the oral drug, just sort of some of that, that expectations there. That's a good question. So, kidney injury starts pretty early after patients go on tacrolimus. Now, not everybody experiences injury enough to qualify as having a renal insufficiency, but there is impact on a large number of patients once they're on tacrolimus in general. And the longer you're on tacrolimus and the higher the dose, then, and given the patient, the level of kidney injury is worse. The patients that we had so far in the clinical trial, they seem to have undergone through a good deal of their renal injury. The fourth patient seemed to have worsening renal injury as they entered the study. They were two and a half to six years into renal insufficiency, so that's a very long time. So in our phase III trial, for example, we would, if the trial is focusing on addressing renal insufficiency specifically, then we would have to try to bring these patients in soon after renal injury has started. So those would be the strategies for capturing the injury before it has become irreversible damage. Got it. And then I imagine that there could be some possibility of, I don't know, if you're randomizing patients who haven't had the renal injury on the oral versus the TFF version, but I guess that could be something for down the line. Just last question for me. I'm wondering if there's any sort of qualitative feedback that you received from patients and physicians who've made use of TFF TAC and TFF VORI on ease of use and just some of those details. Sure. So for TFF TAC, we think it really speaks volumes. The fact that three patients who completed treatment and had the option to go back on oral tacrolimus chose not to do that. They decided to stay on TFF TAC. So you know, in terms of tolerability, that really is a very important indicator. Overall, we've received feedback that people feel it's easy to use the inhaler. The inhaler is quite, you know, easy. You open up the inhaler, you put in a capsule, you close it. There are two red buttons that you press, and then you put the mouthpiece in your mouth and take a deep breath. So to administer the drug is quite easy. It's something patients can do easily at home, and overall, the feedback has been that it's not difficult to use the inhaler. Great. Thanks for taking the question. You're welcome. Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Dr. Weisman for final comments. Thank you. I'd like to thank all of you for joining us today for the TFF VORI and TFF TAC program updates. We're obviously quite excited about these results and believe that each product holds extraordinary potential to offer a meaningful improvement over the current standard of care in their respective rare disease indications. And we look forward to providing you another update sometime in the first quarter of 2024. Thank you. Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.