TFF Pharmaceuticals Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 15, 2023

There are 9 speakers on the call.

Operator

Morning, 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 1

Thank 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 1

Harlan 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 1

Factors 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 1

Recorded. Harlan?

Speaker 2

Thank 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 2

Our 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 2

Recorded. 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 2

Based 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 2

Considering 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 2

Recorded. 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 2

Developing 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 2

We 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 2

We 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 2

I'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 3

Thank 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 3

As 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 3

Oral 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 3

Recorded. 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 3

As 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 3

To 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 3

Recorded. 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 4

a very strong positive efficacy, safety and tolerability results in

Speaker 3

2 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 3

Recorded. 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 3

Given 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 3

Similar 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 3

With 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 3

The 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 3

Recorded. 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 3

Recorded. 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 3

We 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 5

Thanks 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 5

The $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 2

recorded for the comparable period

Speaker 5

in 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 5

As 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 2

Recorded. 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 2

The 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 2

Recorded. Operator?

Operator

Thank 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 6

Thank 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 2

Jonathan, 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 3

Hi, Jonathan.

Speaker 2

Hi.

Speaker 3

Thanks 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 3

Recorded. 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 6

Can 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 3

That'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 3

As 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 3

And 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 3

The 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 6

Thanks 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 3

That'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 3

So 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 3

We 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 3

I'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 3

So 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 6

Okay. 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 3

We'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 6

Okay. 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 5

That'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 6

2024. Yes, I've got you there easily. Okay, thank you very much.

Speaker 2

Recorded. Thank

Operator

you. The next question comes from Justin Walsh of Jones retrading. Please go ahead.

Speaker 7

Hi. 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 2

Yes. Good morning, Justin, and thank you for the question. That one seems

Speaker 3

Thank 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 3

The 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 7

Got it. And Did you have discussions with the FDA or the EMA related to the amendment of the trial?

Speaker 3

Recorded. 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 7

Got 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 3

recorded. 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 3

So 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 7

Got it. Thanks very much.

Speaker 3

Did that answer your question?

Speaker 8

Yes. That does.

Speaker 3

Thank you.

Speaker 2

Recorded. Thank you.

Speaker 3

Thank you.

Operator

The next question comes from Vernon Bernardino from H. C. Wainwright. Please go ahead.

Speaker 4

Sorry, 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 2

Why don't you go ahead and Take that, Azamane. Good morning. Good morning, Vernon, and thank you.

Speaker 4

Hi, Hala.

Speaker 3

Thank 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 3

With 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 3

We 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 4

Great. 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 2

a

Speaker 4

I guess put together, translate, synthesize whatever however you want to describe it into the results that you might see with TFFOI.

Speaker 2

Yes, why don't you go ahead, Dominique, and take that one too.

Speaker 3

Recorded. 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 3

It 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 2

Recorded. 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 4

Perfect. 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 2

Recorded. 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 2

I 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 2

I'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 4

Perfect. I appreciate the insights and the answers to my questions.

Speaker 2

Thank you.

Operator

Recorded. Thank you. The last question comes from Daniel Carlson at Tailwinds. Please go ahead.

Speaker 2

Recorded. Thank

Speaker 8

you 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 2

Dan, first of all, good morning and thank you for We believe the answer is yes, but let me let Zamanay elaborate.

Speaker 3

Hi, Dan. Yes, we believe that will be part of the data package. The expanded access

Speaker 8

Great. 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 3

Sure. 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 3

The 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 3

Recorded. 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 8

Got you. And so can you just, can you comment at all about your screening failure Great. And will this change that?

Speaker 3

It should. It should, because again, previously, Some of the patients that didn't have, the specific, signs and symptoms mentioned in the algorithm,

Speaker 8

recorded. 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 8

Can you elaborate on that And what that means from a clinical standpoint?

Speaker 3

Yes. 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 3

Recorded. 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 3

We'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 3

So 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 8

Got you. That's exciting. Thank you. And Jeanine, thank you. It's obviously done a lot of work at turning these programs around.

Speaker 8

So I want to Thank you for your efforts in that regard.

Speaker 3

Thank you.

Speaker 4

You brought us a long way in

Speaker 8

a 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 2

Thank 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 2

It 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 2

Got

Speaker 8

you. Well, thank you. Appreciate it. Thanks for taking my questions.

Speaker 2

Yes. Thank you, Dan.

Speaker 8

Recorded.

Operator

Thank you. There are no further questions. I will turn the call back over for closing comments.

Speaker 2

Recorded. 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 2

Recorded 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.

Operator

Recorded. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and we ask that you please

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Key Takeaways

  • Under new leadership, TFF advanced two rare-disease programs into Phase 2—TFF-40 (inhaled voriconazole) and TFF-TAC (inhaled tacrolimus)—and expects initial data from approximately 10 patients in each trial by the end of 2023 to guide Phase 3 decisions.
  • TFF-40 program has activated 16 of 19 sites, increased prescreening fivefold, expanded eligibility criteria to real-world IPA diagnoses, and launched a partner-funded expanded access program (Durbin) with the first patient enrolled.
  • TFF-TAC study has dosed three lung transplant patients in Australia, achieving target clinical outcomes at unexpectedly low inhaled doses and anticipates a steady enrollment trajectory toward its ten-patient go/no-go cohort.
  • A recent equity financing (no warrants) plus Q2 cash of $7.7 million and disciplined expense cuts cut net loss to $5 million, extending the cash runway into Q1 2024 with an expected ~\$4 M quarterly burn rate.
  • Three partner-funded collaborations (NIH/NIEHS CRADA, DARPA/Leidos extension, NIAID direct-to-Phase 2 award) validate TFF’s thin film freezing platform for inhaled formulations and vaccines without burdening its balance sheet.
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Earnings Conference Call
TFF Pharmaceuticals Q2 2023
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