NASDAQ:TFFP TFF Pharmaceuticals Q2 2023 Earnings Report $0.06 0.00 (0.00%) As of 04/10/2025 Earnings History TFF Pharmaceuticals EPS ResultsActual EPS-$3.50Consensus EPS -$5.00Beat/MissBeat by +$1.50One Year Ago EPS-$8.50TFF Pharmaceuticals Revenue ResultsActual Revenue$0.33 millionExpected Revenue$0.10 millionBeat/MissBeat by +$230.00 thousandYoY Revenue GrowthN/ATFF Pharmaceuticals Announcement DetailsQuarterQ2 2023Date8/15/2023TimeBefore Market OpensConference Call DateTuesday, August 15, 2023Conference Call Time11:00AM ETConference Call ResourcesConference Call AudioConference Call TranscriptQuarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by TFF Pharmaceuticals Q2 2023 Earnings Call TranscriptProvided by QuartrAugust 15, 2023 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Morning, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Second Quarter 2023 Corporate Update and Earnings Conference Call. As a reminder, this conference is being recorded. I will now turn the call over to your host, Corey Davis of LifeSci Advisors. You may begin your conference. Speaker 100:00:17Thank you, operator. Recorded. Hello, everyone, and welcome to TFF Pharmaceuticals Second Quarter 2023 Corporate Update and Earnings Conference Call. Recorded. With me on the line this afternoon are Doctor. Speaker 100:00:28Harlan Weissman, Chief Executive Officer of TFF Pharmaceuticals Doctor. Zamanay Michak, recorded, Chief Medical Officer and Kirk Coleman, Chief Financial Officer. Before we get started, I would like to remind everyone that this call will contain forward looking statements, recorded, including without limitation, statements about the anticipated timing of achievement of clinical milestones, the potential to see positive effects in our Phase 2 studies, recorded. The number of treated patients necessary to make our decisions in regards to moving to Phase 3 studies, the market opportunity for our product candidates recorded and the expected time frame for funding operations with cash and cash equivalents. These forward looking statements are subject to known and unknown risks and uncertainties recorded that may cause actual results to differ materially from the statements made. Speaker 100:01:15Factors that could cause actual results to differ recorded and are described in all of our findings with the U. S. Securities and Exchange Commission, including the Risk Factors section of our 2022 Annual Report recorded on Form 10 ks filed with the SEC. And now it's my pleasure to turn the call over to Doctor. Harlan Weissman. Speaker 100:01:34Recorded. Harlan? Speaker 200:01:36Thank you, John, and good morning, everyone, and thank you for joining us for our Q2 2023 recorded. On today's call, I'm going to review the significant progress that we've made recorded over the first half of twenty twenty three and then provide an outlook on what we expect to achieve for the remainder of the year. Recorded. Following my remarks, our Chief Medical Officer, Doctor. Zalmanay Michak, will provide an update recorded on TFS Clinical Stage Programs. Speaker 200:02:13Our Chief Financial Officer, Kurt Coleman, will then review our financial results recorded for the Q2. We'll then open up the call for Q and A. In early February, soon after my appointment recorded. As TFF's permanent CEO, we held an investor call to review our corporate strategy recorded and outline our objectives for 2023. On that call, we expressed our commitment to grow shareholder value recorded by prioritizing the advancement of our clinical stage assets, TFF-four thousand and TFF TAC. Speaker 200:02:52Recorded. We also expressed a desire to remain opportunistic with respect to signing new partnerships recorded. It's been nearly 6 months since that call and I can say that I'm proud of the company's progress on both fronts. Under Xamena's leadership, our clinical development team has made considerable progress recorded across a number of key areas to help build physician and patient awareness of TFF-four and TFF TAC. Recorded. Speaker 200:03:34Based on the continued success of these efforts, we anticipate reaching key clinical milestones by year end, recorded, each of which could serve as a major catalyst for our company. In a moment, Zomene will provide greater details recorded on each of these rare disease programs. We will also have sufficient capital to reach these milestones. As announced earlier this morning, PFF raised additional capital through an equity financing. Importantly, No warrants were issued to investors in this transaction. Speaker 200:04:12Considering the ongoing challenges in the capital markets, recorded. Our ability to close this financing while minimizing dilution to our existing shareholders, in my view, recorded. In contrast to programs involving new chemical entities, TFF-four and TFF TAC couple significant innovation with reduced clinical development risk. The innovation is driven of course recorded by our thin film freezing technology that enables efficacious levels of boriconazole and tacrolimus recorded, but with lower toxicity and drug drug interactions compared to systemic delivery. Physicians have told us We also believe each program bears significantly less clinical risk compared to other development stage programs. Speaker 200:05:32Recorded. By improving the delivery of 2 well established first line FDA approved drugs, recorded. We expect to see positive treatment effects for most of the patients enrolling in our ongoing Phase 2 trials. Recorded. For this reason, I believe TFF represents a compelling opportunity for investors who seek an optimal balance of innovation recorded, coupled with lower overall clinical development risk. Speaker 200:06:03Developing new therapies like TFF-four recorded. As a reminder, this conference is being recorded. As a reminder, this conference is being recorded. Recorded. Given the size of the patient population, the level of unmet need, the economic burden of each disease recorded. Speaker 200:07:00We announced 3 separate government collaborations during the quarter, which provide 3rd party validation recorded on the value of our thin film freezing technology. In May, we signed a Cooperative Research and Development Agreement or CRADA with the National Institute of Environmental Health Sciences, part of the National Institutes of Health to develop dry powder formulations recorded of Ohio Euronin to prevent and treat respiratory diseases. NIEHS and PFF We'll evaluate the pharmacogenetics and therapeutic efficacy of PFS hyaluronan formulations recorded using in vitro and in vivo models of select respiratory diseases with a primary focus on chronic obstructive pulmonary disease recorded for COPD and viral respiratory diseases caused by SARS CoV-two, influenza virus recorded and or respiratory syncytial virus or RSV. Also in May, we signed a contract extension with Leidos recorded that provides additional funding to advance next generation personalized protective biosystems recorded under the personalized protective biosystems program managed by the Defense Advanced Research Projects Agency, recorded more commonly referred to as DARPA. The goal of the program is to develop lightweight materials using thin film freezing technology In June, we announced an agreement with the National Institute of Allergy and Infectious Diseases, also part of the National Institutes of Health that awarded TFF Pharmaceuticals a direct to Phase 2 recorded in the quarter. Speaker 200:09:00We are pleased to announce that the company's strong results are being recorded in the quarter. We are pleased to announce that we are recorded using the company's thin film freezing technology. The aim of this program is to develop a vaccine recorded. Importantly, these agreements are largely funded by our partners and provide an important source of external validation for our technology. Recorded. Speaker 200:09:37I'd now like to turn the call over to Doctor. Zomeneh Mitak to discuss the TFF-four recorded and TFF TAC clinical programs. Zamae? Speaker 300:09:50Thank you, Harlan. Recorded. As Harlan mentioned, I'm pleased to share with you the considerable progress we're making to advance enrollment in our 2 Phase 2 trials of TFF TAT reached and TFF-four thousand and forty. Over the last several months, our clinical development team has undertaken multiple initiatives to advance these programs. I'll start recorded by providing an update on TFF-forty. Speaker 300:10:16As a reminder, TFF-forty has been formulated using our thin film freezing technology to deliver antifungal drug, vorticonazole, directly to the lungs. Recorded starting with invasive pulmonary aspergillosis or IPA. IPA is a life threatening recorded. Even with standard of care therapies, the 12 week mortality rate recorded from IPA is approximately 30%, which represents a significant unmet medical need for this rare disease. Recorded. Speaker 300:11:00Oral voriconazole is first line therapy for treatment of IPA, but because of the drug's narrow therapeutic window, Attaining efficacious concentrations often requires dosages that cause significant toxicities. Recorded. By administering TSF-three directly into the lungs, we hope to improve efficacy by delivering high local concentrations of the drug, recorded while lowering systemic exposures and therefore systemic toxicities and drug drug interactions, problems commonly associated with oral administration. Recorded. As Harlan mentioned earlier, we have made considerable progress over the last several months. Speaker 300:11:41Recorded. We established weekly goals for our CRO and weekly meetings with CRO upper management to improve accountability and overall execution, and these reached. For example, we now have 16 of our 19 clinical sites activated recorded. The areas of the TSF-1E program is growing among hematologists, oncologists, infectious disease physicians, pulmonologists and transplant physicians at our active clinical sites recorded and their referral networks, which in turn is leading to an acceleration in patient prescreening and screening activities. Recorded. Speaker 300:12:29As a result, our rate of prescreening has increased nearly 5 fold in the past 4 months compared to the 1st 4 months from 9 to 44, recorded and we now have 2 patients enrolled in our study. Additionally, we have amended the study protocol to improve patient access to recorded. For example, based on feedback from our investigators, we have expanded eligibility to allow real world criteria recorded for the diagnosis of IPA. In a disease with high unmet need, in which first line therapy is associated with high mortality, recorded. Patients often choose to participate in a clinical trial with the hope of receiving an investigational drug with potential for improved efficacy and or toxicity. Speaker 300:13:19To improve the chances of receiving Tiafrafluri, recorded. We have also increased the ratio of patients receiving Piafra40 to those receiving oral voriconazole from 1:one to 3:one in this study. Recorded. While we're developing PFS40 for the potential treatment of IPA by conducting clinical trials, recorded. We understand that in some cases, patients who have exhausted available therapeutic options may not qualify for participation in clinical trials. Speaker 300:13:49Recorded. For such cases, we have launched an expanded access program or EAP, offering TSFAT-four eighty two patients recorded with all forms of pulmonary aspergillosis, including both invasive and chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, The patients who enter our EAP have limited or no treatment options or in some cases have had recorded. The EAP program builds on the recorded. We have Speaker 400:14:39a very strong positive efficacy, safety and tolerability results in Speaker 300:14:392 such patients with pulmonary fungal infections recorded over previously treated with TFF-forty on a compassionate use basis. Recorded. I'm also pleased to note our collaboration with Durbin will help us implement the AEP for TSR-forty in the U. S, Canada, Australia, recorded in the U. Durban has a long track record of executing expanded access programs across the globe recorded for large and small pharma companies, and we are confident that through this partnership, we will be able to provide expanded access to TSR-four thousand and forty to eligible patients. Speaker 300:15:17Recorded. In fact, I'm pleased to note that we have already enrolled our first patient in this new program. Recorded. As Harlan mentioned, we expect to see a majority of patients who receive TFRAC WORRY therapy to show a positive treatment effect recorded due to the well established activity of ruripanizole as an antifungal medication. Recorded. Speaker 300:15:40Given the availability of considerable historical data on the safety, tolerability and efficacy of voriconazole and in line with what is generally customary in rare disease indications. We believe no more than 10 patients treated with TFF-fourteen may be necessary to provide us with enough recorded. Initial data from our ongoing Phase 2 trial in EAP recorded and are expected by the end of 2023. Now let me turn to discussing the TFFTAC Phase 2 program. Recorded. Speaker 300:16:17Similar to TFF-four eighty, the TFF TAC program addresses an area of significant unmet medical need in another rare disease indication. TSF TAC is being developed for prevention of rejection in lung transplant recipients, a patient population with a 5 year mortality rate reached as high as 50%. The 50% 5 year mortality in lung transplant comes largely reached from the narrow therapeutic window of available immunosuppressants, where too little immune suppression leads to acute or chronic rejection, recorded. To overcome these efficiencies, TFF Tech has been formulated using our thin film freezing technology recorded. The direct delivery of CFF tagged to the lungs is poised to potentially address multiple contributing factors to this 50% 5 year mortality recorded. Speaker 300:17:27With local delivery to the lungs, the ratio of lung exposure to systemic exposure increases. Recorded. Therefore, lung concentration sufficient to drive efficacy locally can be achieved at lower doses compared to oral administration, leading recorded. The improved lung to systemic recorded. The disclosure achieved with TFFTAC is predicted to address the fine balance needed for immunosuppression. Speaker 300:17:55The improved concentrations in the lung, recorded. The site of information would address acute and chronic rejection, while diminished systemic exposures recorded and will address potentially fatal complications such as infections, chronic kidney disease and post transplant, lymphoma or other malignancies. Recorded. It should be noted that presence of systemic exposure, albeit at lower levels compared to oral tacrolimus, recorded. In our Phase 2 trial, we have gained considerable insights at our active site in Australia recorded in transitioning lung transplant patients from oral tacrolimus to the inhaled form TFF TAC. Speaker 300:18:45Recorded. The transition from oral to inhaled tacrolimus is a delicate process given the risk of rejection and toxicities. We have been pleasantly surprised recorded for the low doses of TFFTAC needed to date to match overall clinical outcomes from oral tacrolimus. Recorded. To date, 3 patients have enrolled in the Phase 2 study at our active site. Speaker 300:19:14Recorded. Since our selected sites have a large database recorded for lung transplant patients that could be considered for potential enrollment in our study, we expect a steady flow of patients in our TFF TAC study. Recorded. Similar to the TF-five forty program, given the availability of considerable historical data on recorded. And in line with what is general practice in rare indications, recorded. Speaker 300:19:41We believe meaningful clinical data from approximately 10 patients treated with TFF Chat will be sufficient to guide a go no go decision recorded for entering a Phase 3 study, and we expect to report initial data from the ongoing Phase 2 study by the end of 2023. Recorded. I'll now turn the call over to Kirk to review our Q2 financial results. Speaker 500:20:06Thanks very much, Amane. Our cash and cash equivalents as of June 30, 2023 were $7,700,000 recorded. Additional proceeds from the financing transaction announced earlier today will ensure that we have sufficient resources to reach anticipated upcoming clinical recorded and will extend our cash runway to the Q1 of 2024. Research and development expenses for the Q2 of 2023 recorded for $2,700,000 compared to $5,100,000 for the comparable period in 2022. Reached. Speaker 500:20:41The $2,400,000 decrease year over year is primarily a result of reduced clinical and manufacturing expenses. General and administrative expenses for the Q2 of 2023 were $2,700,000 compared to $3,700,000 Speaker 200:20:59recorded for the comparable period Speaker 500:21:00in 2022. $1,000,000 decrease year over year is primarily related to decreased professional fees recorded and patent expenses, insurance, consulting, market research and payroll and payroll related expenses. Recorded. Net loss for the Q2 of 2023 of $5,000,000 compared to a net loss of $8,700,000 for the comparable period in 2022. Recorded. Speaker 500:21:24As Harlan noted previously, we have been focused on spending responsibly as we progress our clinical trial programs. Recorded. I'm proud of the team for successfully reducing spending in areas that were not part of the primary strategic objectives. Speaker 200:21:42Recorded. Thank you, Kirk. Before opening up the call for questions, I would like to express my sincere thanks to Zomine and her team for all of their hard work and dedication, recorded, which has enabled us to make significant progress across multiple fronts in our TFF TAC and TFF VORI program. Since becoming CEO 6 months ago, my confidence in the therapeutic and commercial value of these two assets has only continued to grow. By improving drug delivery with our thin film freezing technology, recorded. Speaker 200:22:21The Vori and TAC programs have the potential to demonstrate a transformative impact in 2 rare disease indications Each addresses areas of significant unmet medical need in rare disease indications with sizable patient populations recorded and substantial market opportunity. If we succeed in this endeavor, I'm equally confident that the value of our technology platform, internal pipeline and partnerships will be increasingly recognized in the market, recorded, providing investors with the opportunity to reassess the value of our company in the months ahead. Recorded. That concludes our formal remarks. And I'd like now to open the call up for the question and answer session. Speaker 200:23:22Recorded. Operator? Operator00:23:25Thank you. Ladies and gentlemen, we will now begin the question and recorded. First question comes from Jonathan Aschoff of ROTH MKM. Please go ahead. Speaker 600:23:53Thank you very much. My first question guys is about, Bory. Given that there's only 2 patients in the trial, what gives you the confidence We can meet that 10 patient expectation by year end. And I guess this explains the 2:one ratio of sites to Speaker 200:24:15Jonathan, hi and good morning and thank you for the question. The clinical trial has been ramping up since Almonay took over as Chief Medical Officer, recorded and it is a process that takes a while to overcome the initial inertia in the clinical trial, but we're now, as Zomide went over in her remarks, Seeing that progress and I'll ask Zomide to comment further on answering your question. Speaker 300:24:50Hi, Jonathan. Speaker 200:24:51Hi. Speaker 300:24:52Thanks for the question. As I mentioned, we have made a significant level of progress. We now have 80% of our sites activated, 16 sites in Europe in 5 different countries. Our investigators are engaged. Our protocol eligibility has been expanded to allow patients that meet real life criteria for diagnosis of IPA. Speaker 300:25:22Recorded. And because we've changed the randomization schedule such that instead of 1 to 1 patients have the opportunity to receive TFF-four with a 3 to 1 chance. The trial is a lot more inviting to patients who would consider participation. Speaker 600:25:57Can you tell me, I mean, up fivefold in the past 4 months, but to only have 2 patients, what's the explanation for So few patients qualifying for this trial? Speaker 300:26:11That's a good question. Recorded. So one of the things that we're noticing is that because it's such a severe disease, considered for the clinical trial actually end up in hospice or palliative care. They're quite ill and that's why they don't qualify. Another reason that they might not qualify is that, the diagnosis ends up not being aspergillus or not being exactly IPA expanded that to include real life criteria and we believe that improves eligibility and study participation. Speaker 300:27:22As I mentioned, we have a lot of sites active now and the investigators are quite engaged. But at the end of the day, we want to make sure we get the right patients in this study. I think the other thing to really keep in mind is that what do you accomplish? What can you accomplish while you're setting things up? Recorded. Speaker 300:27:42And what can you accomplish once you have set things up? So we have brought in the number of patients that we brought in as we've been activating sites, recorded as we've been putting in an addendum, as we've been putting in an amendment. But doing that requires a lot of reached. Now we're at a point where the sites are active. The amendment is in place and approved in almost every country. Speaker 300:28:13The sites are familiar with these broadened eligibility criteria and they understand recorded and how that impacts their evaluation of patients. So that's why looking at the activities on the ground and the information we have, recorded. We're comfortable to project that we'll be able to have initial data by the year end. Speaker 600:28:33Thanks for that. What was flawed about 40 patients As an enrollment number for Vori such that 10 can allow you to come up with a go, no go decision Speaker 300:28:48That's a good question too. The 4 gs patient trial was the original design recorded. You do a 40 patient Phase 2 study, for example, in rheumatoid arthritis, If you're doing a service regular POC or you do it in psoriasis, a big common, big footprint disease. In rare diseases, generally, you look for a smaller sample size in your trials because there are just fewer patients in these trials. For example, IP8, the number of patients with new diagnosis of IP8 worldwide 80,000 patients. Speaker 300:29:39So that's quite a rare disease. So the way one does clinical development in a rare disease indication is that you look for more telling signals of efficacy and that helps you, have a smaller sample size. We also have the luxury that the drug we're developing are first line approved drugs. The chemical entities are not new. So recorded. Speaker 300:30:05We know what voriconazole can do. We know what tacrolimus can do. We understand their efficacy profile. We understand your safety and tolerability profile. So we don't think you need 40 patients to be able to make a call as to how TFF40 is doing compared to, oral voriconazole. Speaker 300:30:25I'll give you an example. With oral voriconazole, About 15% to 20% of patients have to decrease their dose or actually eventually go off therapy recorded because of liver toxicity. That's a really high rate of liver toxicity and that's very well known, very common experience. Recorded. In our clinical trials, we have not seen any patients so far between the healthy volunteers, between patients with mild asthma, between the patients we've had in compassionate use, between the patients we've had so far in our clinical trial, nobody recorded. Speaker 300:31:04So we don't think you're going to need 40 patients to be able to make this call. The difference will be large enough that you'll be able to make a call with just 10 patients. So it's really an adjustment in clinical trial design to match the indication a little bit better. Speaker 600:31:20Okay. So you will make that decision on 10 patients versus 10 doesn't quite look compelling, hey, let's enroll more. Like what do you think you're more likely to do? Just make that call? Or if that's not clearly a yes, Try for some more patients to see if it gets to a yes. Speaker 300:31:43We've always said it's approximately 10 patients. But bottom line is that we don't think you need a lot more than that. Obviously, you'll have to look at your data, make decisions accordingly, But we don't think it will be, you need the original design, which was comparing 20 patients getting TFS-four We think we'll be able to really rely and withdrawn on the experience that the knowledge that's there about oral vorconazole and also you would need fewer patients Speaker 600:32:24Okay. And not to leave Kirk out. Kirk, there were sequential decreases, which is good in R and D and SG and A for the 1st and the second quarter. Are you at a cruising altitude or do you expect that to continue dropping a little? Speaker 500:32:39That's a great question, Jonathan. Thank you. I think we are starting to settle in and the guidance we're giving obviously We're anticipating that our burn rate is about $4,000,000 a quarter and then we've got enough runway to get us through reached to 3Q1 of Speaker 600:32:572024. Yes, I've got you there easily. Okay, thank you very much. Speaker 200:33:05Recorded. Thank Operator00:33:06you. The next question comes from Justin Walsh of Jones retrading. Please go ahead. Speaker 700:33:12Hi. Thanks for taking the questions. Can you expand on the criteria you expect to use for your gono go decisions? What type of results would you need to see to give you confidence that it warrants advancing into Phase 3 for either asset? Speaker 200:33:27Yes. Good morning, Justin, and thank you for the question. That one seems Speaker 300:33:39Thank you, Justin. So we will look at signals of efficacy. For example, in TIATAV-four, we certainly want to see that patients are feeling better. The clinical signs and symptoms have improved and we like to see that there is evidence that Aspergillus has been cleared. Recorded. Speaker 300:34:00The treatment duration is about 12 weeks. That may or may not be long enough to recorded. In the TFF tax program, for example, we want to make sure that as we transition patients from the oral tacrolimus to Danehill tacrolimus, And of course, safety and tolerability is big for TFF40 as well. Speaker 700:34:37Got it. And Did you have discussions with the FDA or the EMA related to the amendment of the trial? Speaker 300:34:48Recorded. We made the amendment and we submitted it to the health authorities in the various countries we're in, in Europe. Received and they've been approved in 4 out of 5 countries and it's under review in the 5th country. Speaker 700:35:05Got it. And then last question for me. You had mentioned that Hospice and some of that angle here, but I'm just wondering if you can remind us or provide commentary on The expanded access and compassionate use of PF HVORI, what alternatives do these patients face either in terms of Speaker 300:35:36recorded. So the expanded access program really provides the opportunity for patients recorded in patients with line transplant, fungal anastomotic infections. There are many areas and also fungal infections that are not Aspergillus but are voriconazole sensitive. So every time you do a clinical trial and you have a clinical trial protocol, you have to implement and cement a particular design. And once that design is cemented, then there are patients who don't qualify based on one thing or another. Speaker 300:36:34So the expanded access program really reached. And these are patients, like you mentioned, who Have tried standard of care therapy at adequate levels and have not had a good response to it or because of Systemic toxicities are not able to tolerate these drugs. The 2 patients we had for compassionate use that were treated previously, For example, for patients who were lung transplant recipients, they had recurrent pulmonary infections, pulmonary fungal infections, And they had significant toxicities to the point that when their infection came back, they were at the end of their rope and They didn't have, they didn't know where to go and that's where TF540 was given to them with very good results. Speaker 700:37:32Got it. Thanks very much. Speaker 300:37:33Did that answer your question? Speaker 800:37:35Yes. That does. Speaker 300:37:36Thank you. Speaker 200:37:39Recorded. Thank you. Speaker 300:37:40Thank you. Operator00:37:40The next question comes from Vernon Bernardino from H. C. Wainwright. Please go ahead. Speaker 400:38:00Sorry, I was muted. Your answers As far as the Vori program has been very informative. So I think I know the answer to my question. Regarding the Phase 2 TFS TAC program though, do you think that the Small number of patients that are going to be dosed with the In the Teck clinical trial We'll be predicting enough to also make a go no go decision for Phase 3? Speaker 200:38:39Why don't you go ahead and Take that, Azamane. Good morning. Good morning, Vernon, and thank you. Speaker 400:38:48Hi, Hala. Speaker 300:38:48Thank you, Vernon. Yes. We think just about 10 patients would be sufficient for us to make a call about TFFTAC as well. Recorded. As I mentioned, we've enrolled 3 patients. Speaker 300:39:04With our first patient, it was the first time we were transitioning patients from oral tacrolimus to inhaled tacrolimus. So we approached it very conservatively watching that patient very carefully, making the transition and then very slowly weaning the dose of inhaled tacrolimus, because you have to have you have to be careful about that balance of making sure the patient doesn't go into rejection while you're improving prospects of safety and tolerability. Recorded. And we as I mentioned, we were surprised of how low we were able to go in the TFF TAC dose. Recorded with the 2nd patient. Speaker 300:39:45We implemented our learnings from the first patient and we're able to duplicate those observations. So obviously, we want to see that happening in a number of other patients, but we think approximately 10 patients will be sufficient to give us the information we need to make a call that yes, this is a goal into Phase 3. And obviously, you continue always to learn from additional patients you bring in, all throughout your development program, but approximately 10 patients should be sufficient. Speaker 400:40:20Great. I look forward to that decision. Now I know an expanded access program It's generally not one designed to provide results, for example. But the Expanded access program, especially with your drugs, DFF, Vori, Intact, but in particular, the voriconazole study. As you mentioned, the small number of patients, would there be a possibility to get any kind of data and or results from that program and would especially with the help of Durban, Ireland or Unifar rather provide Speaker 200:41:10a Speaker 400:41:18I guess put together, translate, synthesize whatever however you want to describe it into the results that you might see with TFFOI. Speaker 200:41:33Yes, why don't you go ahead, Dominique, and take that one too. Speaker 300:41:38Recorded. Sure. Yes, we believe that the information we gather recorded. We are developing TFF bori by conducting a clinical trial and the results of the clinical trial will lead us and help us guide us to understand our next steps and the design of our Phase 3, etcetera. But the information we're gathering reached through the expanded access program is very valuable and adds to that. Speaker 300:42:18It also really expands The indications that we're in, the clinical trial is in invasive pulmonary aspergillosis, the expanded access program And where are the signals of efficacy where we should be pursuing further clinical trials for TFF40? Speaker 200:42:48Recorded. Yes, Dominic, it's probably where I just wanted to I'm sorry, just mentioned that you brought up recorded. And one of the reasons for us signing on with Durbin is that we have although it's not a recorded across the various patients that come into the compassionate use program. So it's not with the same degree of rigor, but there is a systematic data collection Speaker 400:43:31Perfect. That's exactly what I was looking for. And then secondarily, I know you have cash, as Kirk said, through perhaps Q3 2024. My model makes it easy to see that that is certainly true. But if you had additional cash, What other molecules do you think you might think about advancing to clinic and make good sense in Whether they be small studies or just even proof of concept studies where You could generate results that would be would provide additional opportunities for our partnerships. Speaker 200:44:21Recorded. Yes. Thank you for the question. Just to clarify, it's enough cash to get us through the Q1 recorded next year and clearly we're going to have to raise money again based on the expected inflection point from us producing data, we think will be the catalyst to allow us to raise more money. The first order of business when we raise money is to be able to continue to fund the development of TFF Warrior and TFF tax. Speaker 200:44:52I want to ensure We don't drop the ball on those 2 programs and get too unfocused. So that's our initial focus. But recorded. As you pointed out, there are other molecules and we're under we have a process underway to evaluate recorded. We recently required fullecyon niclosamide. Speaker 200:45:18I'm not saying we would go forward with that, but it's in recorded. We have it and we are currently evaluating whether it makes sense to go forward with nacolizumab and indications Besides COVID-nineteen, which was the original idea of it, and we'll evaluate that. But we also had shown that our technology able to take, for example, a large variety of biologics like monoclonal antibodies, Vaccines and we have the agreement with the NIH to develop a universal flu vaccine and mRNAs Speaker 400:46:23Perfect. I appreciate the insights and the answers to my questions. Speaker 200:46:29Thank you. Operator00:46:34Recorded. Thank you. The last question comes from Daniel Carlson at Tailwinds. Please go ahead. Speaker 200:46:40Recorded. Thank Speaker 800:46:40you and good morning everyone. Just a couple of follow-up questions Regarding the expanded access program, is that data something you can submit to the regulatory authorities The FDA or EMA and will they consider that data when advising on potential next steps? Speaker 200:47:03Dan, first of all, good morning and thank you for We believe the answer is yes, but let me let Zamanay elaborate. Speaker 300:47:15Hi, Dan. Yes, we believe that will be part of the data package. The expanded access Speaker 800:47:39Great. Zamanay, you mentioned for the Phase II Vori, Expanding the eligibility criteria with additional real world criteria. Can you just elaborate on what that means exactly? Recorded. Speaker 300:47:56Sure. So with every clinical trial, obviously, you need to make sure that you get the right patient. Recorded because for example, if the patient doesn't have, let's say, aspergillosis, which responds to voriconazole, then obviously one recorded. We couldn't expect TFF-four E to cause improvement. So it's important to make sure you get the right patients in. Speaker 300:48:21The diagnostic criteria that's part of the protocol that is customarily part of the protocol for IPA type recorded. For example, it includes that the patients have to have certain signs and symptoms to be part of that You have that patient with AML who has now developed a fungal pulmonary fungal infection. They see that the patient has increased respiratory symptoms, including a productive cough that has worsened and, that has CT shows a cavity recorded and they grow Aspergillus from their lungs. That patient in the real world gets treated with voriconazole for the probable diagnosis of IPA. But based on that academic set of criteria, that patient wouldn't be considered recorded because worsening cough is not one of the specific signs and symptoms mentioned in that diagnostic criteria. Speaker 300:49:47Recorded. So after talking with our investigators, one of the they gave us feedback about various aspects and one of the The feedback we received was this that in the real world, we actually diagnose patients with IPA, bringing clinical judgment and putting the various parameters together to get a story, get a picture of does this fit Speaker 800:50:29Got you. And so can you just, can you comment at all about your screening failure Great. And will this change that? Speaker 300:50:42It should. It should, because again, previously, Some of the patients that didn't have, the specific, signs and symptoms mentioned in the algorithm, Speaker 800:51:06recorded. Got you. Okay. And then one Question on TAC, as they speak against Omni. You mentioned that you're surprised How little TFF TAC it takes to match the overall clinical outcome from oral TAC limits. Speaker 800:51:24Can you elaborate on that And what that means from a clinical standpoint? Speaker 300:51:31Yes. So patients come in, these are patients who are lung transplant And they've been on oral tacrolimus long enough to start to have the toxic effects of recorded. What do I do with this patient? If I continue the patient on oral tacrolimus at the dosages that I have them on, The kidneys are going to continue to worsen, so I decreased the oral tetralimus hoping they don't go into rejection and maybe I added different types of immunosuppressant as I decrease, oral tacrolimus, but that's going to have its own toxicity. So these are the types of patients right now in this study. Speaker 300:52:33Recorded. So as we take these patients, the patients are doing well from a rejection perspective. They're not rejecting their lungs. Their Oral tacrolimus is keeping rejection at bay, but their kidneys are not functioning well. So we are we have transitioned these patients. Speaker 300:52:55We've learned how to transition, how to take that dose of oral tacrolimus No clinical signs of rejections, no inhaled tacrolimus TFF tag providing them with the benefits of recorded. And then starting to see the beneficial effects of lower toxicity. So obviously, we need to dose many more patients. That's why we think we will need approximately 10 patients to make a final call, but we're just very encouraged. As they say, this is the drug we've been waiting for. Speaker 300:53:55So there's a lot of enthusiasm to hopefully get this drug in the hands of patients and hopefully This is a drug that should be used in assuming we show the type of response we are projecting This is the type of drug that should be used in patients before they develop renal toxicity. There should be no reason recorded for us to wait for patients to develop renal toxicity from oral tacrolimus and then change them to TFF TAC. So In the long run, our goal would be to really have this available for patients from the start. Speaker 800:54:46Got you. That's exciting. Thank you. And Jeanine, thank you. It's obviously done a lot of work at turning these programs around. Speaker 800:54:54So I want to Thank you for your efforts in that regard. Speaker 300:54:57Thank you. Speaker 400:54:58You brought us a long way in Speaker 800:54:59a short time, it appears. So last question for me, Harlan. You focused rightly on the 2 Phase IIs, but there were a number of other potential balls out there in the air. I'm just wondering if there's anything progressing on the 3rd party work that you've We've been working on in the past, if that's just sort of all silent now. Speaker 200:55:24Thank you, Jim, for that question. We still have ongoing collaborations going with some big pharma companies and also biotech companies. Recorded. The one thing we've done is we've changed the emphasis of what we're doing to So as many hooks out there to catch fish, to be more focused and go to the fishing hole focused to be only on those progress that we think we can make a real difference that are business interest to the collaborator And the other is that we want people to pay their way completely. Before we were doing quite a lot of work where we were taking on the burden of the cost. Speaker 200:56:26It wasn't tremendous cost, but we were taking on that burden. Now we wanted Somebody wants to collaborate with us and part of demonstrating that it's important to them is for them paying their way. So we have a more narrowed We've received that pace for our laboratory costs, our human resources devoted to those projects. And we're exploring other opportunities on the non dilutional side of working with government and other organizations. Recorded. Speaker 200:57:07Got Speaker 800:57:08you. Well, thank you. Appreciate it. Thanks for taking my questions. Speaker 200:57:12Yes. Thank you, Dan. Speaker 800:57:15Recorded. Operator00:57:16Thank you. There are no further questions. I will turn the call back over for closing comments. Speaker 200:57:22Recorded. Well, in closing, I'd just like to thank all of you for being on today's call. And I'd especially like to thank all of our investors reached. I'm convinced that TFF-four and TFF TAC programs recorded. We have the potential to significantly advance the current standard of care in their respective rare disease indication. Speaker 200:57:49Recorded and that's why I as well as our officers, directors and employees have purchased significant equity in our company. Recorded. Thank you again, and we look forward to providing another corporate update in November. Operator00:58:06Recorded. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and we ask that you pleaseRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallTFF Pharmaceuticals Q2 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsQuarterly report(10-Q) TFF Pharmaceuticals Earnings HeadlinesTFF Pharmaceuticals approves dissolution planMarch 8, 2025 | uk.investing.comTFF Pharmaceuticals Announces Delisting from Nasdaq and Potential SEC DeregistrationFebruary 6, 2025 | prnewswire.comMost traders are panicking. We’re cashing inMost traders are panicking right now. Bitcoin’s dropping. Altcoins are bleeding. The stock market’s a mess. The news is screaming fear. But while most traders watch their portfolios tank…May 4, 2025 | Crypto Swap Profits (Ad)U.S. stocks lower at close of trade; Dow Jones Industrial Average down 0.70%November 15, 2024 | msn.comTFF Pharmaceuticals Shares Fall 66%; Company to Wind DownNovember 15, 2024 | marketwatch.comTFF Pharmaceuticals terminates employees, to wind down operationsNovember 15, 2024 | markets.businessinsider.comSee More TFF Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like TFF Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on TFF Pharmaceuticals and other key companies, straight to your email. Email Address About TFF PharmaceuticalsTFF Pharmaceuticals (NASDAQ:TFFP), a clinical stage biopharmaceutical company, focuses on developing and commercializing drug products based on its patented Thin Film Freezing (TFF) technology platform in the United States and Australia. It intends to focus on the development of inhaled dry powder drugs for the treatment of pulmonary diseases and conditions. The company's drug candidates are TFF Voriconazole Inhalation Powder, which is in Phase II clinical trials for the treatment and prophylaxis of invasive pulmonary aspergillosis; and TFF Tacrolimus Inhalation Powder, which is in Phase II clinical trials used to prevent lung transplant rejection. It also develops other dry powder products, such as Augmenta human derived monoclonal antibodies for the treatment of COVID-19 disease; and other vaccines. It has a license agreement with the University of Texas at Austin for the development of inhaled dry powder drugs. TFF Pharmaceuticals, Inc. was incorporated in 2018 and is headquartered in Fort Worth, Texas.View TFF Pharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Amazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernVisa Q2 Earnings Top Forecasts, Adds $30B Buyback PlanMicrosoft Crushes Earnings, What’s Next for MSFT Stock?Qualcomm's Earnings: 2 Reasons to Buy, 1 to Stay AwayAMD Stock Signals Strong Buy Ahead of Earnings Upcoming Earnings Palantir Technologies (5/5/2025)Vertex Pharmaceuticals (5/5/2025)Realty Income (5/5/2025)Williams Companies (5/5/2025)CRH (5/5/2025)Advanced Micro Devices (5/6/2025)American Electric Power (5/6/2025)Constellation Energy (5/6/2025)Marriott International (5/6/2025)Energy Transfer (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 9 speakers on the call. Operator00:00:00Morning, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Second Quarter 2023 Corporate Update and Earnings Conference Call. As a reminder, this conference is being recorded. I will now turn the call over to your host, Corey Davis of LifeSci Advisors. You may begin your conference. Speaker 100:00:17Thank you, operator. Recorded. Hello, everyone, and welcome to TFF Pharmaceuticals Second Quarter 2023 Corporate Update and Earnings Conference Call. Recorded. With me on the line this afternoon are Doctor. Speaker 100:00:28Harlan Weissman, Chief Executive Officer of TFF Pharmaceuticals Doctor. Zamanay Michak, recorded, Chief Medical Officer and Kirk Coleman, Chief Financial Officer. Before we get started, I would like to remind everyone that this call will contain forward looking statements, recorded, including without limitation, statements about the anticipated timing of achievement of clinical milestones, the potential to see positive effects in our Phase 2 studies, recorded. The number of treated patients necessary to make our decisions in regards to moving to Phase 3 studies, the market opportunity for our product candidates recorded and the expected time frame for funding operations with cash and cash equivalents. These forward looking statements are subject to known and unknown risks and uncertainties recorded that may cause actual results to differ materially from the statements made. Speaker 100:01:15Factors that could cause actual results to differ recorded and are described in all of our findings with the U. S. Securities and Exchange Commission, including the Risk Factors section of our 2022 Annual Report recorded on Form 10 ks filed with the SEC. And now it's my pleasure to turn the call over to Doctor. Harlan Weissman. Speaker 100:01:34Recorded. Harlan? Speaker 200:01:36Thank you, John, and good morning, everyone, and thank you for joining us for our Q2 2023 recorded. On today's call, I'm going to review the significant progress that we've made recorded over the first half of twenty twenty three and then provide an outlook on what we expect to achieve for the remainder of the year. Recorded. Following my remarks, our Chief Medical Officer, Doctor. Zalmanay Michak, will provide an update recorded on TFS Clinical Stage Programs. Speaker 200:02:13Our Chief Financial Officer, Kurt Coleman, will then review our financial results recorded for the Q2. We'll then open up the call for Q and A. In early February, soon after my appointment recorded. As TFF's permanent CEO, we held an investor call to review our corporate strategy recorded and outline our objectives for 2023. On that call, we expressed our commitment to grow shareholder value recorded by prioritizing the advancement of our clinical stage assets, TFF-four thousand and TFF TAC. Speaker 200:02:52Recorded. We also expressed a desire to remain opportunistic with respect to signing new partnerships recorded. It's been nearly 6 months since that call and I can say that I'm proud of the company's progress on both fronts. Under Xamena's leadership, our clinical development team has made considerable progress recorded across a number of key areas to help build physician and patient awareness of TFF-four and TFF TAC. Recorded. Speaker 200:03:34Based on the continued success of these efforts, we anticipate reaching key clinical milestones by year end, recorded, each of which could serve as a major catalyst for our company. In a moment, Zomene will provide greater details recorded on each of these rare disease programs. We will also have sufficient capital to reach these milestones. As announced earlier this morning, PFF raised additional capital through an equity financing. Importantly, No warrants were issued to investors in this transaction. Speaker 200:04:12Considering the ongoing challenges in the capital markets, recorded. Our ability to close this financing while minimizing dilution to our existing shareholders, in my view, recorded. In contrast to programs involving new chemical entities, TFF-four and TFF TAC couple significant innovation with reduced clinical development risk. The innovation is driven of course recorded by our thin film freezing technology that enables efficacious levels of boriconazole and tacrolimus recorded, but with lower toxicity and drug drug interactions compared to systemic delivery. Physicians have told us We also believe each program bears significantly less clinical risk compared to other development stage programs. Speaker 200:05:32Recorded. By improving the delivery of 2 well established first line FDA approved drugs, recorded. We expect to see positive treatment effects for most of the patients enrolling in our ongoing Phase 2 trials. Recorded. For this reason, I believe TFF represents a compelling opportunity for investors who seek an optimal balance of innovation recorded, coupled with lower overall clinical development risk. Speaker 200:06:03Developing new therapies like TFF-four recorded. As a reminder, this conference is being recorded. As a reminder, this conference is being recorded. Recorded. Given the size of the patient population, the level of unmet need, the economic burden of each disease recorded. Speaker 200:07:00We announced 3 separate government collaborations during the quarter, which provide 3rd party validation recorded on the value of our thin film freezing technology. In May, we signed a Cooperative Research and Development Agreement or CRADA with the National Institute of Environmental Health Sciences, part of the National Institutes of Health to develop dry powder formulations recorded of Ohio Euronin to prevent and treat respiratory diseases. NIEHS and PFF We'll evaluate the pharmacogenetics and therapeutic efficacy of PFS hyaluronan formulations recorded using in vitro and in vivo models of select respiratory diseases with a primary focus on chronic obstructive pulmonary disease recorded for COPD and viral respiratory diseases caused by SARS CoV-two, influenza virus recorded and or respiratory syncytial virus or RSV. Also in May, we signed a contract extension with Leidos recorded that provides additional funding to advance next generation personalized protective biosystems recorded under the personalized protective biosystems program managed by the Defense Advanced Research Projects Agency, recorded more commonly referred to as DARPA. The goal of the program is to develop lightweight materials using thin film freezing technology In June, we announced an agreement with the National Institute of Allergy and Infectious Diseases, also part of the National Institutes of Health that awarded TFF Pharmaceuticals a direct to Phase 2 recorded in the quarter. Speaker 200:09:00We are pleased to announce that the company's strong results are being recorded in the quarter. We are pleased to announce that we are recorded using the company's thin film freezing technology. The aim of this program is to develop a vaccine recorded. Importantly, these agreements are largely funded by our partners and provide an important source of external validation for our technology. Recorded. Speaker 200:09:37I'd now like to turn the call over to Doctor. Zomeneh Mitak to discuss the TFF-four recorded and TFF TAC clinical programs. Zamae? Speaker 300:09:50Thank you, Harlan. Recorded. As Harlan mentioned, I'm pleased to share with you the considerable progress we're making to advance enrollment in our 2 Phase 2 trials of TFF TAT reached and TFF-four thousand and forty. Over the last several months, our clinical development team has undertaken multiple initiatives to advance these programs. I'll start recorded by providing an update on TFF-forty. Speaker 300:10:16As a reminder, TFF-forty has been formulated using our thin film freezing technology to deliver antifungal drug, vorticonazole, directly to the lungs. Recorded starting with invasive pulmonary aspergillosis or IPA. IPA is a life threatening recorded. Even with standard of care therapies, the 12 week mortality rate recorded from IPA is approximately 30%, which represents a significant unmet medical need for this rare disease. Recorded. Speaker 300:11:00Oral voriconazole is first line therapy for treatment of IPA, but because of the drug's narrow therapeutic window, Attaining efficacious concentrations often requires dosages that cause significant toxicities. Recorded. By administering TSF-three directly into the lungs, we hope to improve efficacy by delivering high local concentrations of the drug, recorded while lowering systemic exposures and therefore systemic toxicities and drug drug interactions, problems commonly associated with oral administration. Recorded. As Harlan mentioned earlier, we have made considerable progress over the last several months. Speaker 300:11:41Recorded. We established weekly goals for our CRO and weekly meetings with CRO upper management to improve accountability and overall execution, and these reached. For example, we now have 16 of our 19 clinical sites activated recorded. The areas of the TSF-1E program is growing among hematologists, oncologists, infectious disease physicians, pulmonologists and transplant physicians at our active clinical sites recorded and their referral networks, which in turn is leading to an acceleration in patient prescreening and screening activities. Recorded. Speaker 300:12:29As a result, our rate of prescreening has increased nearly 5 fold in the past 4 months compared to the 1st 4 months from 9 to 44, recorded and we now have 2 patients enrolled in our study. Additionally, we have amended the study protocol to improve patient access to recorded. For example, based on feedback from our investigators, we have expanded eligibility to allow real world criteria recorded for the diagnosis of IPA. In a disease with high unmet need, in which first line therapy is associated with high mortality, recorded. Patients often choose to participate in a clinical trial with the hope of receiving an investigational drug with potential for improved efficacy and or toxicity. Speaker 300:13:19To improve the chances of receiving Tiafrafluri, recorded. We have also increased the ratio of patients receiving Piafra40 to those receiving oral voriconazole from 1:one to 3:one in this study. Recorded. While we're developing PFS40 for the potential treatment of IPA by conducting clinical trials, recorded. We understand that in some cases, patients who have exhausted available therapeutic options may not qualify for participation in clinical trials. Speaker 300:13:49Recorded. For such cases, we have launched an expanded access program or EAP, offering TSFAT-four eighty two patients recorded with all forms of pulmonary aspergillosis, including both invasive and chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, The patients who enter our EAP have limited or no treatment options or in some cases have had recorded. The EAP program builds on the recorded. We have Speaker 400:14:39a very strong positive efficacy, safety and tolerability results in Speaker 300:14:392 such patients with pulmonary fungal infections recorded over previously treated with TFF-forty on a compassionate use basis. Recorded. I'm also pleased to note our collaboration with Durbin will help us implement the AEP for TSR-forty in the U. S, Canada, Australia, recorded in the U. Durban has a long track record of executing expanded access programs across the globe recorded for large and small pharma companies, and we are confident that through this partnership, we will be able to provide expanded access to TSR-four thousand and forty to eligible patients. Speaker 300:15:17Recorded. In fact, I'm pleased to note that we have already enrolled our first patient in this new program. Recorded. As Harlan mentioned, we expect to see a majority of patients who receive TFRAC WORRY therapy to show a positive treatment effect recorded due to the well established activity of ruripanizole as an antifungal medication. Recorded. Speaker 300:15:40Given the availability of considerable historical data on the safety, tolerability and efficacy of voriconazole and in line with what is generally customary in rare disease indications. We believe no more than 10 patients treated with TFF-fourteen may be necessary to provide us with enough recorded. Initial data from our ongoing Phase 2 trial in EAP recorded and are expected by the end of 2023. Now let me turn to discussing the TFFTAC Phase 2 program. Recorded. Speaker 300:16:17Similar to TFF-four eighty, the TFF TAC program addresses an area of significant unmet medical need in another rare disease indication. TSF TAC is being developed for prevention of rejection in lung transplant recipients, a patient population with a 5 year mortality rate reached as high as 50%. The 50% 5 year mortality in lung transplant comes largely reached from the narrow therapeutic window of available immunosuppressants, where too little immune suppression leads to acute or chronic rejection, recorded. To overcome these efficiencies, TFF Tech has been formulated using our thin film freezing technology recorded. The direct delivery of CFF tagged to the lungs is poised to potentially address multiple contributing factors to this 50% 5 year mortality recorded. Speaker 300:17:27With local delivery to the lungs, the ratio of lung exposure to systemic exposure increases. Recorded. Therefore, lung concentration sufficient to drive efficacy locally can be achieved at lower doses compared to oral administration, leading recorded. The improved lung to systemic recorded. The disclosure achieved with TFFTAC is predicted to address the fine balance needed for immunosuppression. Speaker 300:17:55The improved concentrations in the lung, recorded. The site of information would address acute and chronic rejection, while diminished systemic exposures recorded and will address potentially fatal complications such as infections, chronic kidney disease and post transplant, lymphoma or other malignancies. Recorded. It should be noted that presence of systemic exposure, albeit at lower levels compared to oral tacrolimus, recorded. In our Phase 2 trial, we have gained considerable insights at our active site in Australia recorded in transitioning lung transplant patients from oral tacrolimus to the inhaled form TFF TAC. Speaker 300:18:45Recorded. The transition from oral to inhaled tacrolimus is a delicate process given the risk of rejection and toxicities. We have been pleasantly surprised recorded for the low doses of TFFTAC needed to date to match overall clinical outcomes from oral tacrolimus. Recorded. To date, 3 patients have enrolled in the Phase 2 study at our active site. Speaker 300:19:14Recorded. Since our selected sites have a large database recorded for lung transplant patients that could be considered for potential enrollment in our study, we expect a steady flow of patients in our TFF TAC study. Recorded. Similar to the TF-five forty program, given the availability of considerable historical data on recorded. And in line with what is general practice in rare indications, recorded. Speaker 300:19:41We believe meaningful clinical data from approximately 10 patients treated with TFF Chat will be sufficient to guide a go no go decision recorded for entering a Phase 3 study, and we expect to report initial data from the ongoing Phase 2 study by the end of 2023. Recorded. I'll now turn the call over to Kirk to review our Q2 financial results. Speaker 500:20:06Thanks very much, Amane. Our cash and cash equivalents as of June 30, 2023 were $7,700,000 recorded. Additional proceeds from the financing transaction announced earlier today will ensure that we have sufficient resources to reach anticipated upcoming clinical recorded and will extend our cash runway to the Q1 of 2024. Research and development expenses for the Q2 of 2023 recorded for $2,700,000 compared to $5,100,000 for the comparable period in 2022. Reached. Speaker 500:20:41The $2,400,000 decrease year over year is primarily a result of reduced clinical and manufacturing expenses. General and administrative expenses for the Q2 of 2023 were $2,700,000 compared to $3,700,000 Speaker 200:20:59recorded for the comparable period Speaker 500:21:00in 2022. $1,000,000 decrease year over year is primarily related to decreased professional fees recorded and patent expenses, insurance, consulting, market research and payroll and payroll related expenses. Recorded. Net loss for the Q2 of 2023 of $5,000,000 compared to a net loss of $8,700,000 for the comparable period in 2022. Recorded. Speaker 500:21:24As Harlan noted previously, we have been focused on spending responsibly as we progress our clinical trial programs. Recorded. I'm proud of the team for successfully reducing spending in areas that were not part of the primary strategic objectives. Speaker 200:21:42Recorded. Thank you, Kirk. Before opening up the call for questions, I would like to express my sincere thanks to Zomine and her team for all of their hard work and dedication, recorded, which has enabled us to make significant progress across multiple fronts in our TFF TAC and TFF VORI program. Since becoming CEO 6 months ago, my confidence in the therapeutic and commercial value of these two assets has only continued to grow. By improving drug delivery with our thin film freezing technology, recorded. Speaker 200:22:21The Vori and TAC programs have the potential to demonstrate a transformative impact in 2 rare disease indications Each addresses areas of significant unmet medical need in rare disease indications with sizable patient populations recorded and substantial market opportunity. If we succeed in this endeavor, I'm equally confident that the value of our technology platform, internal pipeline and partnerships will be increasingly recognized in the market, recorded, providing investors with the opportunity to reassess the value of our company in the months ahead. Recorded. That concludes our formal remarks. And I'd like now to open the call up for the question and answer session. Speaker 200:23:22Recorded. Operator? Operator00:23:25Thank you. Ladies and gentlemen, we will now begin the question and recorded. First question comes from Jonathan Aschoff of ROTH MKM. Please go ahead. Speaker 600:23:53Thank you very much. My first question guys is about, Bory. Given that there's only 2 patients in the trial, what gives you the confidence We can meet that 10 patient expectation by year end. And I guess this explains the 2:one ratio of sites to Speaker 200:24:15Jonathan, hi and good morning and thank you for the question. The clinical trial has been ramping up since Almonay took over as Chief Medical Officer, recorded and it is a process that takes a while to overcome the initial inertia in the clinical trial, but we're now, as Zomide went over in her remarks, Seeing that progress and I'll ask Zomide to comment further on answering your question. Speaker 300:24:50Hi, Jonathan. Speaker 200:24:51Hi. Speaker 300:24:52Thanks for the question. As I mentioned, we have made a significant level of progress. We now have 80% of our sites activated, 16 sites in Europe in 5 different countries. Our investigators are engaged. Our protocol eligibility has been expanded to allow patients that meet real life criteria for diagnosis of IPA. Speaker 300:25:22Recorded. And because we've changed the randomization schedule such that instead of 1 to 1 patients have the opportunity to receive TFF-four with a 3 to 1 chance. The trial is a lot more inviting to patients who would consider participation. Speaker 600:25:57Can you tell me, I mean, up fivefold in the past 4 months, but to only have 2 patients, what's the explanation for So few patients qualifying for this trial? Speaker 300:26:11That's a good question. Recorded. So one of the things that we're noticing is that because it's such a severe disease, considered for the clinical trial actually end up in hospice or palliative care. They're quite ill and that's why they don't qualify. Another reason that they might not qualify is that, the diagnosis ends up not being aspergillus or not being exactly IPA expanded that to include real life criteria and we believe that improves eligibility and study participation. Speaker 300:27:22As I mentioned, we have a lot of sites active now and the investigators are quite engaged. But at the end of the day, we want to make sure we get the right patients in this study. I think the other thing to really keep in mind is that what do you accomplish? What can you accomplish while you're setting things up? Recorded. Speaker 300:27:42And what can you accomplish once you have set things up? So we have brought in the number of patients that we brought in as we've been activating sites, recorded as we've been putting in an addendum, as we've been putting in an amendment. But doing that requires a lot of reached. Now we're at a point where the sites are active. The amendment is in place and approved in almost every country. Speaker 300:28:13The sites are familiar with these broadened eligibility criteria and they understand recorded and how that impacts their evaluation of patients. So that's why looking at the activities on the ground and the information we have, recorded. We're comfortable to project that we'll be able to have initial data by the year end. Speaker 600:28:33Thanks for that. What was flawed about 40 patients As an enrollment number for Vori such that 10 can allow you to come up with a go, no go decision Speaker 300:28:48That's a good question too. The 4 gs patient trial was the original design recorded. You do a 40 patient Phase 2 study, for example, in rheumatoid arthritis, If you're doing a service regular POC or you do it in psoriasis, a big common, big footprint disease. In rare diseases, generally, you look for a smaller sample size in your trials because there are just fewer patients in these trials. For example, IP8, the number of patients with new diagnosis of IP8 worldwide 80,000 patients. Speaker 300:29:39So that's quite a rare disease. So the way one does clinical development in a rare disease indication is that you look for more telling signals of efficacy and that helps you, have a smaller sample size. We also have the luxury that the drug we're developing are first line approved drugs. The chemical entities are not new. So recorded. Speaker 300:30:05We know what voriconazole can do. We know what tacrolimus can do. We understand their efficacy profile. We understand your safety and tolerability profile. So we don't think you need 40 patients to be able to make a call as to how TFF40 is doing compared to, oral voriconazole. Speaker 300:30:25I'll give you an example. With oral voriconazole, About 15% to 20% of patients have to decrease their dose or actually eventually go off therapy recorded because of liver toxicity. That's a really high rate of liver toxicity and that's very well known, very common experience. Recorded. In our clinical trials, we have not seen any patients so far between the healthy volunteers, between patients with mild asthma, between the patients we've had in compassionate use, between the patients we've had so far in our clinical trial, nobody recorded. Speaker 300:31:04So we don't think you're going to need 40 patients to be able to make this call. The difference will be large enough that you'll be able to make a call with just 10 patients. So it's really an adjustment in clinical trial design to match the indication a little bit better. Speaker 600:31:20Okay. So you will make that decision on 10 patients versus 10 doesn't quite look compelling, hey, let's enroll more. Like what do you think you're more likely to do? Just make that call? Or if that's not clearly a yes, Try for some more patients to see if it gets to a yes. Speaker 300:31:43We've always said it's approximately 10 patients. But bottom line is that we don't think you need a lot more than that. Obviously, you'll have to look at your data, make decisions accordingly, But we don't think it will be, you need the original design, which was comparing 20 patients getting TFS-four We think we'll be able to really rely and withdrawn on the experience that the knowledge that's there about oral vorconazole and also you would need fewer patients Speaker 600:32:24Okay. And not to leave Kirk out. Kirk, there were sequential decreases, which is good in R and D and SG and A for the 1st and the second quarter. Are you at a cruising altitude or do you expect that to continue dropping a little? Speaker 500:32:39That's a great question, Jonathan. Thank you. I think we are starting to settle in and the guidance we're giving obviously We're anticipating that our burn rate is about $4,000,000 a quarter and then we've got enough runway to get us through reached to 3Q1 of Speaker 600:32:572024. Yes, I've got you there easily. Okay, thank you very much. Speaker 200:33:05Recorded. Thank Operator00:33:06you. The next question comes from Justin Walsh of Jones retrading. Please go ahead. Speaker 700:33:12Hi. Thanks for taking the questions. Can you expand on the criteria you expect to use for your gono go decisions? What type of results would you need to see to give you confidence that it warrants advancing into Phase 3 for either asset? Speaker 200:33:27Yes. Good morning, Justin, and thank you for the question. That one seems Speaker 300:33:39Thank you, Justin. So we will look at signals of efficacy. For example, in TIATAV-four, we certainly want to see that patients are feeling better. The clinical signs and symptoms have improved and we like to see that there is evidence that Aspergillus has been cleared. Recorded. Speaker 300:34:00The treatment duration is about 12 weeks. That may or may not be long enough to recorded. In the TFF tax program, for example, we want to make sure that as we transition patients from the oral tacrolimus to Danehill tacrolimus, And of course, safety and tolerability is big for TFF40 as well. Speaker 700:34:37Got it. And Did you have discussions with the FDA or the EMA related to the amendment of the trial? Speaker 300:34:48Recorded. We made the amendment and we submitted it to the health authorities in the various countries we're in, in Europe. Received and they've been approved in 4 out of 5 countries and it's under review in the 5th country. Speaker 700:35:05Got it. And then last question for me. You had mentioned that Hospice and some of that angle here, but I'm just wondering if you can remind us or provide commentary on The expanded access and compassionate use of PF HVORI, what alternatives do these patients face either in terms of Speaker 300:35:36recorded. So the expanded access program really provides the opportunity for patients recorded in patients with line transplant, fungal anastomotic infections. There are many areas and also fungal infections that are not Aspergillus but are voriconazole sensitive. So every time you do a clinical trial and you have a clinical trial protocol, you have to implement and cement a particular design. And once that design is cemented, then there are patients who don't qualify based on one thing or another. Speaker 300:36:34So the expanded access program really reached. And these are patients, like you mentioned, who Have tried standard of care therapy at adequate levels and have not had a good response to it or because of Systemic toxicities are not able to tolerate these drugs. The 2 patients we had for compassionate use that were treated previously, For example, for patients who were lung transplant recipients, they had recurrent pulmonary infections, pulmonary fungal infections, And they had significant toxicities to the point that when their infection came back, they were at the end of their rope and They didn't have, they didn't know where to go and that's where TF540 was given to them with very good results. Speaker 700:37:32Got it. Thanks very much. Speaker 300:37:33Did that answer your question? Speaker 800:37:35Yes. That does. Speaker 300:37:36Thank you. Speaker 200:37:39Recorded. Thank you. Speaker 300:37:40Thank you. Operator00:37:40The next question comes from Vernon Bernardino from H. C. Wainwright. Please go ahead. Speaker 400:38:00Sorry, I was muted. Your answers As far as the Vori program has been very informative. So I think I know the answer to my question. Regarding the Phase 2 TFS TAC program though, do you think that the Small number of patients that are going to be dosed with the In the Teck clinical trial We'll be predicting enough to also make a go no go decision for Phase 3? Speaker 200:38:39Why don't you go ahead and Take that, Azamane. Good morning. Good morning, Vernon, and thank you. Speaker 400:38:48Hi, Hala. Speaker 300:38:48Thank you, Vernon. Yes. We think just about 10 patients would be sufficient for us to make a call about TFFTAC as well. Recorded. As I mentioned, we've enrolled 3 patients. Speaker 300:39:04With our first patient, it was the first time we were transitioning patients from oral tacrolimus to inhaled tacrolimus. So we approached it very conservatively watching that patient very carefully, making the transition and then very slowly weaning the dose of inhaled tacrolimus, because you have to have you have to be careful about that balance of making sure the patient doesn't go into rejection while you're improving prospects of safety and tolerability. Recorded. And we as I mentioned, we were surprised of how low we were able to go in the TFF TAC dose. Recorded with the 2nd patient. Speaker 300:39:45We implemented our learnings from the first patient and we're able to duplicate those observations. So obviously, we want to see that happening in a number of other patients, but we think approximately 10 patients will be sufficient to give us the information we need to make a call that yes, this is a goal into Phase 3. And obviously, you continue always to learn from additional patients you bring in, all throughout your development program, but approximately 10 patients should be sufficient. Speaker 400:40:20Great. I look forward to that decision. Now I know an expanded access program It's generally not one designed to provide results, for example. But the Expanded access program, especially with your drugs, DFF, Vori, Intact, but in particular, the voriconazole study. As you mentioned, the small number of patients, would there be a possibility to get any kind of data and or results from that program and would especially with the help of Durban, Ireland or Unifar rather provide Speaker 200:41:10a Speaker 400:41:18I guess put together, translate, synthesize whatever however you want to describe it into the results that you might see with TFFOI. Speaker 200:41:33Yes, why don't you go ahead, Dominique, and take that one too. Speaker 300:41:38Recorded. Sure. Yes, we believe that the information we gather recorded. We are developing TFF bori by conducting a clinical trial and the results of the clinical trial will lead us and help us guide us to understand our next steps and the design of our Phase 3, etcetera. But the information we're gathering reached through the expanded access program is very valuable and adds to that. Speaker 300:42:18It also really expands The indications that we're in, the clinical trial is in invasive pulmonary aspergillosis, the expanded access program And where are the signals of efficacy where we should be pursuing further clinical trials for TFF40? Speaker 200:42:48Recorded. Yes, Dominic, it's probably where I just wanted to I'm sorry, just mentioned that you brought up recorded. And one of the reasons for us signing on with Durbin is that we have although it's not a recorded across the various patients that come into the compassionate use program. So it's not with the same degree of rigor, but there is a systematic data collection Speaker 400:43:31Perfect. That's exactly what I was looking for. And then secondarily, I know you have cash, as Kirk said, through perhaps Q3 2024. My model makes it easy to see that that is certainly true. But if you had additional cash, What other molecules do you think you might think about advancing to clinic and make good sense in Whether they be small studies or just even proof of concept studies where You could generate results that would be would provide additional opportunities for our partnerships. Speaker 200:44:21Recorded. Yes. Thank you for the question. Just to clarify, it's enough cash to get us through the Q1 recorded next year and clearly we're going to have to raise money again based on the expected inflection point from us producing data, we think will be the catalyst to allow us to raise more money. The first order of business when we raise money is to be able to continue to fund the development of TFF Warrior and TFF tax. Speaker 200:44:52I want to ensure We don't drop the ball on those 2 programs and get too unfocused. So that's our initial focus. But recorded. As you pointed out, there are other molecules and we're under we have a process underway to evaluate recorded. We recently required fullecyon niclosamide. Speaker 200:45:18I'm not saying we would go forward with that, but it's in recorded. We have it and we are currently evaluating whether it makes sense to go forward with nacolizumab and indications Besides COVID-nineteen, which was the original idea of it, and we'll evaluate that. But we also had shown that our technology able to take, for example, a large variety of biologics like monoclonal antibodies, Vaccines and we have the agreement with the NIH to develop a universal flu vaccine and mRNAs Speaker 400:46:23Perfect. I appreciate the insights and the answers to my questions. Speaker 200:46:29Thank you. Operator00:46:34Recorded. Thank you. The last question comes from Daniel Carlson at Tailwinds. Please go ahead. Speaker 200:46:40Recorded. Thank Speaker 800:46:40you and good morning everyone. Just a couple of follow-up questions Regarding the expanded access program, is that data something you can submit to the regulatory authorities The FDA or EMA and will they consider that data when advising on potential next steps? Speaker 200:47:03Dan, first of all, good morning and thank you for We believe the answer is yes, but let me let Zamanay elaborate. Speaker 300:47:15Hi, Dan. Yes, we believe that will be part of the data package. The expanded access Speaker 800:47:39Great. Zamanay, you mentioned for the Phase II Vori, Expanding the eligibility criteria with additional real world criteria. Can you just elaborate on what that means exactly? Recorded. Speaker 300:47:56Sure. So with every clinical trial, obviously, you need to make sure that you get the right patient. Recorded because for example, if the patient doesn't have, let's say, aspergillosis, which responds to voriconazole, then obviously one recorded. We couldn't expect TFF-four E to cause improvement. So it's important to make sure you get the right patients in. Speaker 300:48:21The diagnostic criteria that's part of the protocol that is customarily part of the protocol for IPA type recorded. For example, it includes that the patients have to have certain signs and symptoms to be part of that You have that patient with AML who has now developed a fungal pulmonary fungal infection. They see that the patient has increased respiratory symptoms, including a productive cough that has worsened and, that has CT shows a cavity recorded and they grow Aspergillus from their lungs. That patient in the real world gets treated with voriconazole for the probable diagnosis of IPA. But based on that academic set of criteria, that patient wouldn't be considered recorded because worsening cough is not one of the specific signs and symptoms mentioned in that diagnostic criteria. Speaker 300:49:47Recorded. So after talking with our investigators, one of the they gave us feedback about various aspects and one of the The feedback we received was this that in the real world, we actually diagnose patients with IPA, bringing clinical judgment and putting the various parameters together to get a story, get a picture of does this fit Speaker 800:50:29Got you. And so can you just, can you comment at all about your screening failure Great. And will this change that? Speaker 300:50:42It should. It should, because again, previously, Some of the patients that didn't have, the specific, signs and symptoms mentioned in the algorithm, Speaker 800:51:06recorded. Got you. Okay. And then one Question on TAC, as they speak against Omni. You mentioned that you're surprised How little TFF TAC it takes to match the overall clinical outcome from oral TAC limits. Speaker 800:51:24Can you elaborate on that And what that means from a clinical standpoint? Speaker 300:51:31Yes. So patients come in, these are patients who are lung transplant And they've been on oral tacrolimus long enough to start to have the toxic effects of recorded. What do I do with this patient? If I continue the patient on oral tacrolimus at the dosages that I have them on, The kidneys are going to continue to worsen, so I decreased the oral tetralimus hoping they don't go into rejection and maybe I added different types of immunosuppressant as I decrease, oral tacrolimus, but that's going to have its own toxicity. So these are the types of patients right now in this study. Speaker 300:52:33Recorded. So as we take these patients, the patients are doing well from a rejection perspective. They're not rejecting their lungs. Their Oral tacrolimus is keeping rejection at bay, but their kidneys are not functioning well. So we are we have transitioned these patients. Speaker 300:52:55We've learned how to transition, how to take that dose of oral tacrolimus No clinical signs of rejections, no inhaled tacrolimus TFF tag providing them with the benefits of recorded. And then starting to see the beneficial effects of lower toxicity. So obviously, we need to dose many more patients. That's why we think we will need approximately 10 patients to make a final call, but we're just very encouraged. As they say, this is the drug we've been waiting for. Speaker 300:53:55So there's a lot of enthusiasm to hopefully get this drug in the hands of patients and hopefully This is a drug that should be used in assuming we show the type of response we are projecting This is the type of drug that should be used in patients before they develop renal toxicity. There should be no reason recorded for us to wait for patients to develop renal toxicity from oral tacrolimus and then change them to TFF TAC. So In the long run, our goal would be to really have this available for patients from the start. Speaker 800:54:46Got you. That's exciting. Thank you. And Jeanine, thank you. It's obviously done a lot of work at turning these programs around. Speaker 800:54:54So I want to Thank you for your efforts in that regard. Speaker 300:54:57Thank you. Speaker 400:54:58You brought us a long way in Speaker 800:54:59a short time, it appears. So last question for me, Harlan. You focused rightly on the 2 Phase IIs, but there were a number of other potential balls out there in the air. I'm just wondering if there's anything progressing on the 3rd party work that you've We've been working on in the past, if that's just sort of all silent now. Speaker 200:55:24Thank you, Jim, for that question. We still have ongoing collaborations going with some big pharma companies and also biotech companies. Recorded. The one thing we've done is we've changed the emphasis of what we're doing to So as many hooks out there to catch fish, to be more focused and go to the fishing hole focused to be only on those progress that we think we can make a real difference that are business interest to the collaborator And the other is that we want people to pay their way completely. Before we were doing quite a lot of work where we were taking on the burden of the cost. Speaker 200:56:26It wasn't tremendous cost, but we were taking on that burden. Now we wanted Somebody wants to collaborate with us and part of demonstrating that it's important to them is for them paying their way. So we have a more narrowed We've received that pace for our laboratory costs, our human resources devoted to those projects. And we're exploring other opportunities on the non dilutional side of working with government and other organizations. Recorded. Speaker 200:57:07Got Speaker 800:57:08you. Well, thank you. Appreciate it. Thanks for taking my questions. Speaker 200:57:12Yes. Thank you, Dan. Speaker 800:57:15Recorded. Operator00:57:16Thank you. There are no further questions. I will turn the call back over for closing comments. Speaker 200:57:22Recorded. Well, in closing, I'd just like to thank all of you for being on today's call. And I'd especially like to thank all of our investors reached. I'm convinced that TFF-four and TFF TAC programs recorded. We have the potential to significantly advance the current standard of care in their respective rare disease indication. Speaker 200:57:49Recorded and that's why I as well as our officers, directors and employees have purchased significant equity in our company. Recorded. Thank you again, and we look forward to providing another corporate update in November. Operator00:58:06Recorded. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and we ask that you pleaseRead morePowered by