TFF Pharmaceuticals Q3 2023 Earnings Call Transcript

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November 14, 2023

There are 8 speakers on the call.

Operator

Afternoon, ladies and gentlemen, and welcome to the TSF Pharmaceuticals Third Quarter 2023 Corporate Update and Earnings Conference Call. As a reminder, this conference is being recorded. I will now turn the call over to our host, Corey Davis of LifeSci Advisors. You may begin your conference.

Speaker 1

Thank you, operator. Hello, everyone, and welcome to TFF Pharmaceuticals' 3rd quarter 2023 corporate update and earnings conference call. With me on the line this afternoon are Doctor. Harlan Weissman, Chief Executive Officer of TFF Pharmaceuticals Doctor. Zamanay Meakak, Chief Medical Officer and Kirk Coleman, Chief Financial Officer.

Speaker 1

Before we get started, I'd like to remind everyone that this call will contain forward looking statements, including without limitation statements about the anticipated timing of achievement of clinical milestones, the potential to see positive effects in our Phase 2 studies, a number of treated patients necessary to make decisions in regards to moving to Phase 3 studies, the market opportunity for our product candidates 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 that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described and all of our filings with the U. S. Securities and Exchange Commission, including the Risk Factors section of our 2022 Annual Report on Form 10 ks filed with the SEC.

Speaker 1

Now it's my pleasure to turn the call over to Doctor. Harlan Wiseman. Go ahead, Harlan.

Speaker 2

Thank you, Corey, and good afternoon, everyone, and thank you for joining us for our Q3 2023 corporate update and earnings conference call. Last quarter, we detailed the considerable progress that we've made across a number of key areas in our ongoing Phase 2 studies of TFF-four and TFF TAC. Based on these accomplishments and subsequent progress, We continue to expect initial clinical data from the Phase 2 studies by year end. Assuming results from both trials are positive, We believe these initial data will serve as a major catalyst for our company by providing the strongest evidence to date of how thin film freezing can improve drug safety and efficacy in 2 rare disease patient populations. In anticipation of these data readouts, I'd like to spend most of our time on today's call discussing how TFF defines clinical success for both programs.

Speaker 2

We will therefore spend time reviewing what endpoints will be presented and their clinical relevance within the context of these two rare disease indications. Our Chief Medical Officer, Doctor. Zomeneh Mekak, will lead this discussion in a moment. Following her remarks, our Chief Financial Officer, Kirk Coleman, will review our 3rd quarter results. We'll then open up the call for a quick Q and A.

Speaker 2

Before turning the call over to Zomene, I would like to briefly note that we continue to closely manage our expenses while prioritizing how we allocate our capital resources. In August, we closed a $5,700,000 equity financing, providing us with sufficient funding to reach the initial data readouts for the TFF-four and TFF TAC programs and extending our runway into the Q2 of 2024. Anticipating positive data from these studies, We continue to review our longer term capital planning efforts as we think about advancing our 2 clinical programs into registration enabling studies. To that end, our 2023 proxy statement contains 2 voting items that are critical for executing our corporate strategy over the next several months, including a request to increase the company's stock authorization and a request to implement a reverse stock split should the Board determine that it's necessary. Respectively, these two initiatives could significantly facilitate future fundraising efforts and ensure that we remain in compliance with NASDAQ listing requirements.

Speaker 2

We hope to have your support for both of these two important voting items. With that, I'll now turn the call over to Zamanay, who will preview our upcoming data readouts for TFF-four and TFF TAC Phase 2 programs. Zomini?

Speaker 3

Thank you, Harlan. As Harlan mentioned, I'm pleased to review with you the type of initial data we plan to share by year end for the TFF40 and TFF TAC Phase 2 studies, focusing on the endpoints, your clinical relevance and the definition of success. I'll start with TFF-forty. Let's begin with the unmet medical need and the value proposition for TFF-four TFF-four is being developed as a potential treatment for pulmonary fungal infections, including pulmonary aspergillosis, starting with invasive pulmonary acidulosis 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.

Speaker 3

Voriconazole is first line therapy for patients with IPA. However, when administered orally or intravenously for a conozolus is associated with high rates of toxicity and drug drug interaction. 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. Good drug interactions represent another significant limitation of oral and intravenous voriconazole.

Speaker 3

Voriconazole can increase or decrease the levels of other drugs needed for the treatment of the patient's underlying illness such as chemotherapeutic or immunosuppressive agents, driving these drugs to sub therapeutic or toxic levels respectively. 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%, which clearly represents a significant unmet medical need for dysrhoeia disease. There are approximately 250,000 patients globally with invasive aspergillosis, which we believe represents a significant opportunity for TFF40. Thin film freezing technology enables us to address this opportunity by delivering voriconazole directly into the lungs where the IP infection resides.

Speaker 3

Through localized delivery, we hope to drive efficacy while minimizing the patient's systemic exposure and thus systemic toxicities and drug drug interactions. Our decision to advance TFF-fourteen into Phase 2 testing was based upon acceptable safety and tolerability results in Phase 1 studies and positive efficacy results in 2 patients with pulmonary fungal infections treated with TFFO-three on a compassionate use basis. The Phase 1a study with 65 healthy volunteers and the Phase 1b study with 16 mild asthmatics demonstrated that doses up to 80 milligrams twice a day were well tolerated and showed no signs of the toxicities commonly reported for oral and intravenous for Oconazole. Results from the 2 compassionate use patients were also favorable. Both patients had a history of recurrent pulmonary fungal infections and systemic toxicities from available antifungal standard of care therapies.

Speaker 3

As a result of treatment with TFAP-four Lung function stabilized, as shown in the middle chart. Lung lesions improved, as shown on the chart to the far right, and fungal infection cleared as per Julis in 1 patient, CytoSpora in the other patient. In both cases, There was no need for hospitalization. Treatment with TFF-four resulted in no drug drug interactions and no adverse events were reported. Based on the favorable results from the Phase 1 studies and the 2 compassionate use patients' Phase 2 study was initiated in Europe.

Speaker 3

The ongoing Phase 2 trial is a randomized open label study evaluating TFF-four reverseus oral voriconazole. The duration of treatment is 13 weeks and the trial endpoints include safety and tolerability, clinical, radiologic and mycologic responses as well as all cause mortality. Before entering the 13 week treatment period, patients are screened to establish the diagnosis of proven or probable IPA. During the screening process, we gain an understanding of the patient's underlying condition that renders them immunocompromised and makes them vulnerable to fungal infections like IPA. We confirm that the patient's infection is indeed caused by Aspergillus.

Speaker 3

By visualizing Aspergillus under the microscope or growing it in culture or by detecting its DNA by detecting galactomannan, which is a piece of the cell wall of aspergillus that can break off and enter the bloodstream. We document the signs and symptoms caused by the infection with Aspergillus such as fever, chest pain, coughing up blood and shortness of breath and record their severity. We examined the impact of the infection on lung function through spirometry, which is a test of how much air the patient can inhale or exhale and how fast. For example, FED-one or forced expiratory volume 1, which measures the maximum amount of air a patient can forcefully exhale in one second can be decreased in the setting of IPA. Finally, we assessed the impact of infection on lung structures through chest CT imaging and look for abnormalities such as nodules or spots in the lungs or cavities.

Speaker 3

The parameters that establish the disease status at baseline, such as evidence of infection, signs and symptoms, lung function and lung structure abnormalities form the endpoints of the study. Overall treatment response is assessed by mycologic response, defined as clearance of daspergillus infection, by clinical response, defined as improvement in signs and symptoms or lung function via spirometry 3 and or by radiologic response defined as improvement in lung structure, VHSCT. Once through the screening process, patients enter the treatment period of the trial and are randomized in its 3:one ratio to receive either 80 milligrams of TFF-forty twice a day or 200 milligrams oralvorecarnizole 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 through the 13 week treatment period for signs and symptoms, lung function and galactomannan.

Speaker 3

Test CTs repeated after 8 weeks 13 weeks of treatment to detect improvements in lung structural abnormalities. Now I'd like to briefly discuss our Expanded Access Program or EAP. We launched our EAP in July in partnership with Durbin to provide access to TFF-fourteen for patients in need who do not qualify for our ongoing Phase 2 study. The EAP provides 12 weeks of treatment with TFF-forty to patients who have limited or no other treatment options who have had an unfavorable response to adequate standard of care therapy. As you can see, our EAP encompasses many forms of pulmonary aspergillosis and also includes patients who have pulmonary fungal infections other than aspergillosis data responsive to treatment with vorticonazole.

Speaker 3

Our U. S. Expanded access protocol was submitted to the FDA late last spring and the EAP is now open in the U. S, Canada, Australia, the U. K.

Speaker 3

And select EU countries. Together, we expect our Phase 2 trial in EAP will provide meaningful evidence for the potential of TFF40 for a treatment of pulmonary fungal infection. Given the considerable amount of historical safety and efficacy data with voriconazole in this rare disease indication, we anticipate data from approximately 10 patients will be sufficient to guide a Phase 3 go no go decision. We plan to share initial data from a subset of these patients by year end and a more complete data set by the end of Q1 2024. The year end data will include assessment of safety, tolerability and treatment response.

Speaker 3

The mycologic response will be defined by no evidence of aspergillus in the assays performed post treatment, for example, decreased or non detectable galactomannan. The clinical response will be defined as improvement in signs and symptoms and or lung function measures such as FEV1. A radiologic response will be defined by improvement in the abnormal findings and chassis such as the number and or size of nodules or spots or cavities, etcetera. So how do we define success for TFFOI? We define success as an overall decrease in toxicities commonly seen with oral or intravenous vorasol, a decrease in drug drug interactions compared with historical data and evidence of mycologic, clinical and or radiologic response after 12 or 13 weeks of treatment with TFF-fourteen in the majority of patients.

Speaker 3

Now I'd like to discuss our TFF TAC Phase 2 program. TFF TAC is being developed to address a significant unmet need in lung transplant rejection. By way of background, tacrolimus is a first line calcineurin inhibitor indicated for the prevention of rejection in line transplant. However, there are well known significant toxicities associated with the oral and intravenous formulation. TFF Tech has been designed using thin film freezing to deliver an inhaled form of tacronus directly into the lung, which is the site of inflammation against the transplanted organ to drive efficacy through immunosuppression locally, while limiting systemic exposures and systemic toxicities.

Speaker 3

Similar to TSR-four TESAR- TAC addresses a high unmet medical need. Patients receiving a lung transplant have an expected 5 year mortality rate of approximately 50% due to oral tacomus' narrow therapeutic index. Too little immune suppression leads to acute rejection or chronic rejection leading to chronic lung allograft dysfunction or clog, 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 TFFTAC with the potential to improve upon the current standard of care. Similar to TFF-four eighty, the decision to advance TFF TAC into Phase 2 testing was supported by strong preclinical and Phase 1 data, which demonstrated acceptable safety and tolerability and an attractive differentiated pharmacokinetic profile compared to the oral tacrolimus.

Speaker 3

Our preclinical data demonstrated a favorable distribution of trial showing high concentrations of the drug in the lung relative to systemic blood levels. In our Phase 1 study in healthy subjects, daily dosing of up to 5 milligrams in a single dose and 1.5 milligram in repeated doses were generally well tolerated. Our ongoing Phase 2 trial of TFF TAC is an open label single arm study in lung transplant patients to require reduced tacrolimus blood levels due to kidney toxicity. The study is designed in 2 parts. Part A is a 12 week treatment period and Part B is an optional safety expansion period.

Speaker 3

Prior to receiving treatment, patients go through a 2 week screening period to collect several baseline measurements. Baseline kidney function is documented and bronchoscopy is performed to make sure patients do not have a lung infection. 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 served as a non invasive biomarker of stress or injury to the transplanted lung due to rejection.

Speaker 3

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 Tech. Clinicians then monitor tacrolimus blood levels and adjust the dose of TFFTAC as needed to achieve tacrolimus blood levels that are approximately 2 thirds to 1 half of the patient's blood levels on oral tacrolimus. These blood levels are expected to be high enough to avoid rejection, but low enough to reduce toxicities. Following the treatment period, the same endpoints measured during the screening phase are reassessed, including spirometry for lung function, bronchoscopy biopsy for genomics analysis and donor drive cell free DNA for signs of stress or injury to get transplanted lung.

Speaker 3

Safety and tolerability, RSF has selected study including assessment of kidney function through glomerular infiltration rate and creatinine levels. Patients are then given the option to enter the trial's open label expansion. Similar to oral voriconazole, there exists a significant amount of historical patient safety and efficacy data for oral tacrolimus. We therefore believe that clinical data from approximately 10 patients will be sufficient to help us determine a Phase 3 go no go decision. We plan to share initial data from a subset of these patients by year end and a more complete data set by the end of the Q1 2024.

Speaker 3

So again, how do we define success for TFF TAC at this stage? Because TFF TAC delivers tacrolimus directly into the lungs, we expect to achieve a higher concentration of tacrolimus in the lung relative to the systemic circulation. As a result, we expect to provide immune suppression sufficient to prevent rejection at lower systemic exposures, that is at lower cost of systemic toxicities. We define success as the ability to transition patients from oral tacrolimus to TFF Tech, achieve tacrolimus blood levels that are approximately 2 thirds to 1 half of the patients' blood levels on oral tacrolimus prevent rejection at these diminished tacrolimus blood levels while stabilizing kidney function. As mentioned, bronchoscopy and biopsy will be repeated at the end of the treatment period.

Speaker 3

Genomic analysis of the biopsy sample will inform presence or absence of rejection. Blood will be obtained and assessed for donor derived cell free DNA to look for injury and stress to the transplanted lung and other potential sign of impact rejection. Lung function will be assessed as well as glomerular filtration rate and creatinine to understand kidney function. That concludes my presentation under upcoming data readouts for our TFF-forty TFF Tech programs. I'll now turn the call over to Kirk to review our Q3 financial results.

Speaker 3

Kirk?

Speaker 4

Thank you very much, Aminai. Our cash and cash equivalents as of September 30, 2023 were $9,700,000 based on gross proceeds of $5,700,000 received from the financing transaction that closed on August 17. Our current cash runway is expected to fund operations into the Q2 of 2024. We remain mindful of our capital resources and continue to monitor our expenses to ensure we are only spending on our core activities. Research and development expenses Q3 of 2023 were $2,400,000 compared to $4,000,000 for the comparable period in 2022.

Speaker 4

The $1,600,000 decrease year over year is primarily a result of reduced clinical and manufacturing expenses. General and administrative expenses for the Q3 of 2023 were $2,300,000 compared to $3,300,000 for the comparable period in 2022. The $1,000,000 decrease year over year is primarily related to decreased professional fees, patent expenses, insurance, consulting, market research, payroll and related expenses. And net loss for the Q3 of 2023 of $4,400,000 compared to a net loss of $7,300,000 comparable period in 2022. And now, I'll turn the call back over to Harlan.

Speaker 2

Thank you, Kurt. I hope today's call has provided you with a clear understanding of our TFF Lori and TFF TAC Phase 2 trial designs, clinical endpoints and most importantly with the value we hope to bring to patients who are suffering from these 2 rare diseases. I think it's also worth mentioning once again that relative to clinical programs involving new chemical entities, We believe the development risk associated with the TFF-four and TFF TAC programs is significantly reduced given the well established historical data available for these molecules. Generating positive results in our Phase 2 studies will further validate our technology and demonstrate how our lead pipeline assets, TFF-four and TFF TAC, represent significant improvements over the current standard of care. I would like to thank our shareholders for your continued support and confidence in TFF Pharmaceuticals.

Speaker 2

And we look forward to updating you on our progress throughout the rest of the year. That concludes our formal remarks.

Operator

Questions will be taken in the order received. Your first question is from Jonathan Ashok from Roth. Please ask your question.

Speaker 5

Thank you. Good afternoon, guys. I know that you're not giving precise enrollment or And yes, enrollment update, but what can you qualitatively say about how enrollment has improved between now and second quarter call, Specifically for Vori.

Speaker 2

Jonathan, hi. Thanks for your question. I'll turn that over to Zomene.

Speaker 3

Hi, Jonathan. Thanks for the question. We have 95% of our sites active at this point and 90% of them are actively prescreening. Because of that our enrollment rate has increased very significantly and now we match what is generally the enrollment rate in IPA Phase 2 clinical trial. To enroll a clinical trial, you need to have active sites And if you need to have hospitals with investigators, sub investigators, study coordinators, nurses, pharmacists that are fully trained in the conduct of the study and you have to have the right equipment there for measuring safety and efficacy parameters and then you have to have drug on-site for dosing the patients.

Speaker 3

We spent pretty much the first half of twenty twenty three activating our clinical trial sites and then amending our protocol to broaden eligibility and also to change the randomization ratio from 1 to 1 to 3 to 1 to increase access to TFFOI through the clinical trial. And through all of these efforts now, We see the active sites participating in prescreening very effectively. And as a result of that, we're on track to communicate initial data that's available to us by year end and then a more complete data set by the end of Q1, 2024.

Speaker 5

Thank you. What is the size of your Phase 2 program say about what we might expect for Phase 3 enrollment numbers?

Speaker 3

In terms of enrollment rate?

Speaker 6

What was that?

Speaker 3

Sure. In terms of enrollment rate? Enrollment numbers, size of the trial. I see. The size of the trial is something that we are still working on and ultimately we will need to have FDA feedback before we can finalize any particular type of plan.

Speaker 3

No matter what the size of the trial, what we expect is that the enrollment rate for the Phase 3 would be in general faster than enrollment for Phase 2. That's generally the case in Phase 3 trials because especially if all cause mortality or any type of mortality is part of the endpoints of this study, you will allow patients that are generally sicker into this study. And by the time you are doing a Phase 3, you have more clinical data when that helps in general with enrollment with investigators and patients participating. So generally speaking, we expect enrollment rates to be higher for our Phase 3. But in terms of the total sample size and what the number would be, we really have to finalize that after we've had FDA interactions.

Speaker 5

Okay. So you said 10 patients is enough for your go or no go Phase 2 decision. But does 10 patients meet is 10 patients Something that's also sufficient to be able to have an end of Phase 2 meeting with the FDA and get their sign off for a Phase 3 program design?

Speaker 3

Sure. Harlan, I take that one.

Speaker 2

Yes, please.

Speaker 3

So we anticipate that data from approximately with 10 patients will be sufficient for us to hold a meeting with the FDA to present our thoughts and questions and to get feedback on the Phase 3 trial design. We really go back to the concept that voriconazole is not a new chemical entity. There is a great deal of safety, tolerability and efficacy data about voriconazole, TRACONIS for that matter. We know these are active drugs, active ingredients with desired pharmacodynamic effect. And also we know that we're in rare, 2 rare indications.

Speaker 3

So because of that, we believe the data from 10 patients will be quite informative and it will allow us to, interact with the FDA, get feedback. We plan to do that as early as possible and as often as possible such that we come to a Phase 3 design that's is efficient and optimized for the indication?

Speaker 5

Okay. So this is the first time that you're saying year end 'twenty three for some amount of data in 1 quarter 2024 for more data. This is for Vori in particular. I don't think you said that about TAC. What's going to be the difference in those two data releases?

Speaker 5

Is 1Q 2024 going to be more patients but the same parameters? Or are you going to have Different parameters on the same number of patients.

Speaker 6

How will this data release going to differ?

Speaker 3

Sure, sure. It's a combination. We expect to have data on a subset of patients by year end and present all the data we have. So some patients will have finished the 12 weeks of treatment and some patients will have finished 8 weeks and some will have finished 4 weeks and some will have finished 2 weeks of treatment. So we will present all the data that we have on the subset of patients and then we will have a more complete data set with approximately 10 patients and the parameters that we discussed by the end of Q1 2024.

Speaker 5

Okay. So it's highly likely, more likely than not that you won't have 10 patients by the end of this year, but you'll have them by the end of 21st quarter. Is that accurate?

Speaker 3

That is accurate.

Speaker 5

All right. Thank you very much.

Operator

Thank you. Your next question is from Justin Walsh from Jones Training. Please ask your question.

Speaker 7

Hi, thanks for taking the questions. I guess a couple related to the data release and your potential end of Phase 2 meeting with the FDA. I'm just trying to get a sense of what expectations people should be thinking about with respect to the level of efficacy that they would be looking for? And maybe what other forms of either adverse events or safety concerns that the FDA might Be looking out for like you mentioned both oraconazole and tacrolimus are very well known. So they know the overall profile, but I don't know if there's something maybe more specific with an inhalable formulation that Bill want to have information on.

Speaker 7

So any more details on that would be helpful.

Speaker 2

Yes. Justin, thank you for the question. And again, Dominic, that seems that you're best positioned to answer that.

Speaker 3

Sure. With respect to safety and tolerability, there are certainly certain adverse events that are very common when you use oral or intravenous voriconazole. Then three top reasons for discontinuing boroclonal is, hepatic toxicity. Liver function tests go up 3, 4, 5 times the upper limit of normal. And at some point, physicians decide whether their patient has signs and symptoms of hepatic toxicity, this is getting too uncomfortable and they stop oral or intravenous or oconazole.

Speaker 3

Visual disturbances are quite uncomfortable for patients. It's a very common reason for discontinuing treatment. Rashes are very common. So we will certainly we are certainly looking for all of these types of adverse events and following those and we expect to certainly report on adverse events in a comparative way compared with the historical data. With respect to what types of signs and symptoms might be common to or might happen with inhaled therapy, certainly with any type of inhaled therapy, you look for evidence of bronchospasm or uncontrollable cough or things of the sort and certainly we follow those and we also plan to report on those in the upcoming data release.

Speaker 3

We will report What we have, we will report the data and that's available to us by the end of this year and share that both in terms of safety, tolerability and efficacy. It will be in a subset of patients. And as I mentioned, patients will have been treated for varying amounts of times, what we believe what we present will be directionally informative in the same way that the 2 compassionate use patients that we originally presented was very informative. So we expect that that

Speaker 1

will

Speaker 3

form the base of then the data or the more complete data set that we'll share by the end of Q1 2024.

Speaker 7

Great. Thanks. And just one more for me. Obviously, the big focus has been on rightly so on TFF Ori and TFF TAC. But maybe just provide a quick commentary on some of the other work that you guys have been doing and maybe some other things that you might be excited about That possible applications of thin film freezing that you'd like to highlight.

Speaker 2

Yes. So I'll take that one. Well, we're continuing our collaborations with pharma and biotech companies, and we've been able to demonstrate that the technology has utility in creating dry powder formulations for a variety of molecules like monoclonal antibodies, vaccines, RNAs, other biologics, as well as small molecules. As an example, last week, we announced the publication results of our collaboration with Aptar Pharma, where we use the TFF process to nasal cavity using the Aptar unit dose nasal spray system. But Justin, it's important to emphasize that it's too early to say whether any of these collaborations will result in a meaningful business opportunity for company and review all of them as the potential upside to the tremendous potential of TFF-four and TFF

Operator

Thank you. Your next question is from Daniel Carlson from Tailwinds. Please ask your question.

Speaker 6

Hi, guys. Thanks for taking my questions. Just on VorianTAC, I know cash is At some point, if you had to make a choice between the programs, how would you decide which one to move forward on?

Speaker 2

Yes. Hi, Dan. And thanks for participating and asking your question. Well, of course, we'd like to go forward with both programs, but we're going to let the data drive our decisions. We will have to consider the potential for each commercially, things like acute versus chronic treatment, the competitive environment.

Speaker 2

It also is going to depend on interactions with the FDA and our ability to raise appropriate funds for both programs.

Speaker 6

Got you. Okay. And then you had an SBIR grant for I think $3,000,000 for universal flu vaccine program. Can you talk about the status of that? Sure.

Speaker 2

This is a collaborative research program with the Cleveland Clinic. It's well underway. Although the goal of the program is develop an IND ready vaccine, that's probably 3 years away. The initial work is focused on developing formulations. And once we've completed this formulation work, we'll begin animal testing.

Speaker 2

It's important to say that the program underscores the recognition of our technology with entities such as the NIH

Speaker 3

and

Speaker 2

our ability to create dry thin film freezing formulations, which can be applied broadly, including and this program for universal off the shelf vaccine. And it's also a perfect example of the potential for additional non dilutive financing.

Speaker 6

Got you. Okay. Thanks guys. Appreciate the update. That's all for me.

Speaker 2

Thank you. Thanks, Dan.

Operator

Thank you. There are no further questions at this time. I will now hand the call back to Harlan for closing remarks.

Speaker 2

Well, once again, I appreciate All the participants in today's call and hearing our update, particularly Appreciate the support of our investors who have had faith in us and we're looking forward to presenting

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Key Takeaways

  • Management expects initial Phase 2 data for both TFF-101 and TFF-TAC by year-end 2023, with a complete dataset by Q1 2024 to inform and accelerate Phase 3 trial design.
  • TFF-101 (inhaled voriconazole) is being developed to treat invasive pulmonary aspergillosis by delivering drug directly to the lungs to minimize systemic toxicities and drug–drug interactions, with success measured by improved safety and mycologic, clinical or radiologic responses.
  • An Expanded Access Program (EAP) launched in July 2023 provides up to 12 weeks of TFF-101 treatment for patients ineligible for the Phase 2 trial across the U.S., Canada, Australia, the U.K. and select EU countries.
  • TFF-TAC (inhaled tacrolimus) aims to prevent lung transplant rejection and preserve kidney function by achieving adequate lung immunosuppression at lower systemic exposures, with success defined by stabilized graft biomarkers and maintained renal metrics.
  • The company closed a $5.7 million equity financing in August 2023, extending its cash runway into Q2 2024, and reported a Q3 net loss of $4.4 million versus $7.3 million a year earlier due to disciplined R&D and G&A expense management.
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Earnings Conference Call
TFF Pharmaceuticals Q3 2023
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