Q2 2023 TFF Pharmaceuticals Inc Earnings Call

Speaker 1: is growing among hematologists, oncologists, infectious disease physicians, pulmonologists, and transplant physicians as our active clinical sites and their referral networks, which in turn is leading to an acceleration in patient prescreening and screening activities. As a result, our rate of prescreening has increased nearly fivefold in the past four months compared to the first four months from 9 to 44.

Speaker 2: Good morning ladies and gentlemen and welcome to the TFF Pharmaceutical 2nd 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 3: Thank you, operator. Hello, everyone, and welcome to TFF Pharmaceuticals second quarter 2023 corporate update and earnings conference call.

Speaker 3: With me on the line this afternoon are Dr. Harlem Weisman, Chief Executive Officer of TFF Pharmaceuticals, Dr. Zamane Miekac, Chief Medical Officer, and Kurt Coleman, Chief Financial Officer.

Speaker 3: Before we get started, I would 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.

Speaker 3: the potential to see positive effects in our phase two studies, the number of treated patients necessary to make our decisions in regards to moving to phase three 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 in all of our findings with the US Securities and Exchange Commission, including the risk factor section of our 2022 annual report on Form 10K filed with the SEC. Now it's my pleasure to turn the call over to Dr. Harlan Weissman. Harlan. Thank you, John , and good morning, everyone. Thank you for joining us for our second quarter, 2023 corporate update and earnings conference call. On today's call, I'm going to review the significant progress that we've made over the first half of 2023, and then provide an outlook on what we expect to achieve for the remainder of the year. Following my remarks, our Chief Medical Officer, Dr. Zamanay Meekak, will provide an update on TFS clinical stage programs. Our Chief Financial Officer, Kurt Coleman,

Speaker 3: In contrast to programs involving new chemical entities, TFFVori and TFFTAC, couple significant innovation with reduced clinical development risk. The innovation is driven, of course, by our thin film-freezing technology that enables efficacious levels of war, connoissell, antichrolemus to be delivered directly into the lungs. Through this improved delivery, we expect to see strong efficacy, but with lower toxicity and drug-drug interactions compared to systemic delivery. Physicians have told us that they would welcome these types of solutions to improve overall care in these highly vulnerable patient populations. We also believe each program bears significantly less clinical risk compared to other development stage programs by improving the delivery of two well-established.

Speaker 3: first-line FDA-approved drugs, we expect to see positive treatment effects for most of the patients enrolling in our ongoing phase two trials. For this reason, I believe TFF represents a compelling opportunity for investors who seek an optimal balance of innovation coupled with lower overall clinical development risk. Developing new therapies like TFF Worry and TFF TAC that can efficiently deliver an effective drug while lowering systemic toxicities is likely to have a significant positive impact on overall patient health, clinical outcomes, and health economics. Given the size of the patient population, the level of unmet need, the economic burden of each disease, and the anticipated impact of TFF Worry and TFF TAC on clinical outcomes, we believe each product represents a $1 billion-plus market opportunity.

You know, you focused rightly on the two phase twos, 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 third-party work that you've been working on in the past, if that's just sort of all silent now.

Thank you, Dan, for that question. We still have ongoing collaborations going with some big pharma companies and also biotech companies. It is going on in the background. The one thing we've done is we've changed the emphasis of what we're doing to throw is Washington cards as the

as many hooks out there to catch fish, to be more focused and go to the fishing hole where the fish actually are. And so we're saying, one, we've narrowed our...

the focus to be only on those programs that we think we can make a real difference, that are business interests to the collaborator that might lead to, where we can add value that might lead to a business deal in the future. And the other is that we want people to pay their way completely. Before we were doing quite a lot of research, we were doing a lot of research on the business side.

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

Thanks for sharing my questions. Yeah, thank you, Dan.

Thank you. Thank you.

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 who've demonstrated their belief in and support of our company.

I'm convinced the TFF40 and TFF-TAP programs

have the potential to significantly advance

the current standard of care and their respective rear disease indication.

And that's why I, as well as our officers, directors, and employees, have purchased significant equity in our company.

Thank you again and we look forward to providing another corporate update in November .