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spk08: Good afternoon, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Second Quarter 2021 Financial Results 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.
spk09: Thank you, Operator. Hello, everyone, and welcome to the TFF Pharmaceuticals Second Quarter 2021 2021 Financial and Business Results Conference Call. With me on the line today is Glenn Mattis, President and CEO of TFF, Kirk Coleman, CFO, Dr. Dale Christensen, TFF's Director of Clinical Development, Dr. Bill Williams of the University of Texas at Austin, and Chris Cano, TFF's Chief Operating Officer. Announcing our second quarter results is available on the TFF Pharmaceuticals website. Please take a moment to read the disclaimer about full-looking statements in the release. The earnings release and this teleconference both include forward-looking statements, and these 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 the disclaimer and in our filings with the U.S. Securities and Exchange Commission, including the risk factors section of our 2020 annual report on Form 10-K filed with the SEC. And now it's my pleasure to turn the call over to Mr. Glenn Mattis.
spk02: Thank you, Corey. Good afternoon, and thank you for joining us today to review TFF's second quarter operations and recent highlights. During the call, I will provide an update on our clinical and corporate progress, and then I will ask our head of clinical development, Dr. Dale Christensen, to update us on the important progress we're making in our internal clinical programs. Following Dale's remarks, Kurt Coleman, our chief financial officer, will then review the company's financials for the quarter. Following Kurt's comments, Dr. Bill Williams of the University of Texas at Austin will provide an update on the latest R&D advancements using our thin-film freezing platform technology, as well as an update on the expansion of our intellectual property estate. Finally, Chris Cano, our Chief Operating Officer and Head of Business Development, will update us on business development and operational initiatives for the company with the value of our thin-film freezing technology is enabling us to expand the number of meaningful partnerships with pharmaceutical companies, academic institutions, and the government health agencies. We'll then open up the call for your questions. As we enter the second half of 2021, TFF is now poised to reach several value-creating inflection points in the voriconazole and tacrolimus development programs. Each of the therapeutic markets represent a substantial commercial opportunity For our company, we estimate the yearly market potential for both compounds to be meaningful. Boriconazole is forecasted to take a significant share of the invasive pulmonary aspergillosis market, focusing on the patient segment requiring treatment beyond 30 days. For tacrolimus, we have forecasted sales potential to exceed $1 billion once approved for lung, kidney, heart, and liver transplant patients. Given the optimal pharmacokinetics of our inhaled formulations, we are confident that both Vori and TAC will demonstrate efficacy and better adverse events profiles over the oral formulations currently on the market. Let me briefly review our progress made to date and then what investors can expect in terms of our catalysts in the second half of 2021. In July, we announced the successful completion of single ascending and multiple ascending dose studies for tacrolimus. Later in the call, Dale Christensen will describe the significance of these data in greater detail on why TFF tacrolimus represents an exciting opportunity in the setting of lung treatment. With respect to voriconazole, earlier in the year, we announced the successful completion of the Phase I clinical trial, and based on these results, TFF plans to study the 80 milligram dose of TFF borine in the planned pivotal trial. So for you, the investors, I want the message to be clear. TFF Pharmaceuticals is now poised to enter 2022 with pivotal trials being conducted for our two lead internal programs, each of which represents a substantial commercial opportunity. At our present valuation, I believe that many investors are simply not paying close enough attention to the progress we have made to date. But with expected advancement of TFF Tacrolimus and Voraconazole, into pivotal testing, we anticipate a positive shift in how investors perceive the value of our internal pipeline. TFF has two later stage differentiated proprietary drug candidates, each targeting highly attractive markets with the potential to generate significant future revenues. To help investors better understand the TFF story, we held a virtual Science Day event back in June. highlighting our thin-film freezing technology and its applications in transplants and vaccines. The event featured three key opinion leaders' perspectives. Dr. Deborah Levine from UT Health San Antonio provided background on lung transplantation, the current toxicity limitation of oral tacrolimus for immunosuppression, and the potential improvements with an inhaled formulation of tacrolimus, referencing, of course, our TFF tacrolimus program. Dr. Kartik Chandran from the Albert Einstein College of Medicine then discussed the benefits of using the TFF technology to create a dry powder pulmonary formulation for RVSV vaccine against COVID-19. And Dr. Ted Ross from the University of Georgia discussed his experience utilizing the TFF process for creating a universal influenza vaccine for pulmonary delivery and its potential benefit over their existing annual vaccination. For those investors who could not attend our science day, the webcast and presentation materials for this event can be accessed on the TFF corporate website. As the TFF development programs advance for voriconazole, tacrolimus, niclosamide, and our antibody collaborations with augmented biosciences, we also understand the importance of building the company's capabilities to further support maturing clinical programs. As part of that effort, today I'm very pleased to announce the formation of TFF Pharmaceuticals Scientific Advisory Board. We have assembled an extraordinary group of accomplished individuals who are globally recognized as thought leaders in their respective fields. The members of the TFF Scientific Advisory Board are Dr. David Kornfield. Dr. Kornfield is Professor of Pulmonary Medicine and the Director of the Center for Excellence in Pulmonary Biology. at Stanford University. Dr. David Denning, who is a Professor of Infectious Diseases and Global Health, University of Manchester. Dr. Anthony Hickey, Director of the University of North Carolina UNC at Chapel Hill, Catalyst for Rare Diseases. Dr. Jay Peters, Chief of Pulmonary and Critical Care Medicine at the University of Texas Health Science Center in San Antonio. Dr. Ted Ross, Professor at the University of Georgia in the Animal Health Research Center, Center for Vaccines and Immunology, and the Department of Infectious Diseases. Dr. Michael Sag, Professor of Medicine and Associate Dean for Global Health at the UAB School of Medicine in Alabama. And last but not least, Dr. Drew Weissman, Professor of Medicine for the Perelman School of Medicine at the University of Pennsylvania. I'm sure you will agree that this is an outstanding scientific advisory board. These renowned experts share the interest in the potential of the thin-film freezing technology and are excited to help contribute their expertise and guidance to help the company optimize its potential. At this point in our company's growth, we believe that this was the right time to add significant depth and expertise in medicine, medicinal chemistry, virology, and the formulation sciences as we continue to advance multiple programs, both internally and for our numerous and growing portfolio of partnerships. The full biographies of our SAB will be posted on our company website. Before moving on to a review of our existing partnership and business development programs, I also want to share with you some important additions to the TFF team. In the area of manufacturing and product development, Dr. John Kohling will be transitioning from his current role as consultant to a full-time position as Vice President of Product Development and Manufacturing. John has been a key contributor to TFF since its inception. Now, as the internal programs progress and the number of partnership programs increase, I've asked John to join the team in this role. We've also added another key person to this group reporting to John. That person is Don Owens, who will join the company as Director of Product Development. Don has an extensive background in the field of inhaled drug delivery and formulation. Now, having reviewed the progress on our internal programs and company growth initiatives, let me review the recent development in our external partnerships. As you all know, the TFF business strategy has two elements, applying the thin-film freezing technology to developing products internally and then licensing those assets to partners for commercialization, and then licensing access to the technology to pharmaceutical company partners to formulate their assets. Last quarter, we highlighted our worldwide licensing agreement with Union Therapeutics for thin-film freezing to produce both an oral and inhaled version. Importantly, recent data from Union suggests that niclosamide is effective against the new prevalent COVID-19 variants. TFF is progressing the development of niclosamide and will begin the Phase I programs later this year. Just recently, TFF announced additional progress in our second COVID-19-directed program with our partner, Augmenta Bioworks. TFF and Augmenta announced the selection of a lead monoclonal antibody, AUG-3387, which is being developed for the prevention and treatment of COVID-19. Similar with our union collaboration, we considered our partnership with Augmented to be an important example of how our thin-film freezing technology can be applied to develop proprietary therapeutics addressing a large unmet medical need in the area of public health, and also demonstrates the application of the thin-film freezing technology in biologics. We're also pleased that Catalan Biologics has been selected to conduct cell line development utilizing their proprietary GPEX platform, and to lead drug substance manufacturing and scale-up efforts for AUG 3387 as the program advances through our clinical development. Our work with PLUS products on the syn-film freezing versions of cannabinoids has entered into the market testing phase. PLUS has successfully produced formulations that they determined to be ready for consumer input. We expect feedback from those efforts shortly. And finally, our work with NeuroRx and Greenlight is also moving forward well. Currently, we were working with the majority of the top 20 pharmaceutical companies as measured by sales, in some cases on multiple open MTAs at various stages. Our number of material transfer agreements and statements of work also steadily increases. I remain highly confident in our ability to close two meaningful transactions by the end of 2021. This has been our stated annual goal for licensing transactions. Later in our call, our Chief Operating Officer and Head of Business Development, Chris Cano, will provide a more detailed review of our partnership and business development activities. Before reviewing our quarterly financial results, I want to turn the call over to Dr. Dale Christensen, our Head of Clinical Development, who will give you more detail on the outstanding progress we continue to make with our programs. Dale?
spk12: Thank you, Glenn, and good afternoon to everyone who has joined our update call today. In the last quarter, we made tremendous progress in our internal clinical development programs. On our first quarter conference call, I provided details about the safety and pharmacokinetic results from our phase one trial of inhaled boriconazole powder, or TFF-40. in Healthy Normal Volunteers. These data were used to initiate a Phase 1B study in asthma patients to understand if the TFF4E is likely to trigger bronchospasm in patients with hyperreactive airway diseases when dosed up to the 80 milligram dose that we intend to pursue for our pivotal clinical studies. Despite the effects of the pandemic on clinical trials globally, We continue to enroll asthma patients and have demonstrated that the 40 milligram dose was well tolerated and upon completion of a safety review of pulmonary function testing and complete clinical data, dose escalation to the 80 milligram twice daily dose was approved. We're currently completing the enrollment of that 80 milligram dosing cohort. Importantly, this reactive airway study sets the stage for our pivotal studies by providing guidance on whether patients with asthma or other diseases with hyper-responsive airways should be premedicated with a bronchodilator or whether this pretreatment will not be required. To be clear, pretreatment would not stop development because other anti-infectives that are inhaled do require pretreatment, but if we don't require pretreatment, our label claims would be cleaner than those compounds. The data generated to date suggests that we have a clear path to initiate our Phase II studies and to get this moving. We have begun to interact with regulatory agencies to define endpoints for the pivotal studies and will file for regulatory approvals to start treating patients with invasive pulmonary aspergillosis by the end of the year. In addition to the voriconazole results, I am also pleased to report that dosing of all subjects in our Phase I study of tacrolimus inhalation powder was completed successfully. We've also completed the chronic toxicology study that is required by the FDA for registration, and we are preparing for a phase two study in lung transplant patients. During our science day, Dr. Levine provided guidance that lung transplant patients undergo therapeutic drug monitoring of maintenance 12-hour trough tricholomus levels so that they achieve blood levels of 5 to 15 nanograms per mil after transplant. Dosing to these blood levels for oral tacrolimus is required to get a high enough concentration of tacrolimus in the lung tissues to prevent acute allograft rejection. In our phase one study in healthy normal subjects, we dosed for a total of seven days and found that the TFF formulation of inhaled tacrolimus has greater bioavailability than oral prograph. And with a one milligram twice daily dose of inhaled tacrolimus, the mean blood levels of the subjects in the cohort reached almost 15 nanograms per mil. That's the upper limit of what's needed for successful immunosuppression in lung transplant patients. We believe this ability to efficiently reach therapeutic drug levels with our tacrolimus inhalation powder dramatically reduces the risk for the program. Furthermore, this data, when coupled with the demonstrated deposition in the lung during toxicology study, supports our working hypothesis that we can reduce systemic exposure to levels that are safer for the kidney and other organs while maintaining sufficient levels in the lung to prevent rejection. We are currently preparing for dialogue with regulatory agencies and expect to initiate phase two study activities by the end of the year. Turning to our partner programs. I also want to report that TFF Pharmaceuticals has completed dosing and toxicology studies with our niclosamide product designed to treat COVID-19 and other respiratory viral infections. These data are supportive of continued development, and we expect enrollment in our phase one study of inhaled niclosamide to begin in early Q4. Finally, we also announced that we had selected a lead monoclonal antibody as part of our collaboration agreement with Augmenta Bioworks. Together with Augmenta, we selected Catalan Biopharma to manufacture the antibody for toxicology and clinical supplies, and this work is ongoing with promising early results. We've also been screening for binding and neutralization of the lead antibody known as AUG3387, to measure potential efficacy against newly emerging variants as an ongoing part of the development program. We were excited to find that our lead compound neutralizes the Delta variant that is currently sweeping through the US and locations around the world. This exciting data underscores the critical need to accelerate development of AUG3387, which could provide a critical therapy not only for newly infected patients, but for preventing infection in patients who are at high risk of COVID-19 complications once infected with the SARS-CoV-2 virus. This becomes possible because the stable dry powder created using the TFF process can easily be administered at home, and the dose reduction that can be achieved by direct pulmonary delivery means that more people can receive the drug for every manufacturing run. The stability at room temperature also means that it can be more easily distributed to places where the cold chain requirements of most biological drugs limit their availability. And with that update, I'd like to turn the call over to our Chief Financial Officer, Kirk Coleman, for a review of the financials. Kirk?
spk00: Thank you very much, Dale. For the three months ended June 30th, 2021, research and development expenses for the company were $2.8 million. compared to 2.6 million for the same period in 2020. The increase in research and development expenses during 2021 was due to increased preclinical activity related to niclosamide and increased clinical activity related to Vorientac. The ramp up also includes our preliminary analysis and testing of dry powder formulations of several drugs and vaccines we believe have the potential to become product candidates. General administrative expenses for the three months ended June 30th, 2021 were 2.4 million compared to 1.3 million in 2020. The company reported net loss for the quarter of 4.7 million compared to a net loss of 3.8 million in 2020. Weighted average common shares outstanding, basic and diluted, for the three months into June 30th, 2021, were 25,369,144 compared with 19,071,658 for the same period in 2020. As of June 30th, 2021, we had a total assets of approximately 57.2 million and working capital of approximately 53.9 million. At the end of the quarter, our liquidity included approximately 52.1 million of cash and cash equivalents. And with that, I'd like to turn the call over to Dr. Bill Williams, who will talk about some of the groundbreaking work we're doing using our thin film freezing platform. particularly with large molecule biologics and how our technology is unique in its ability to successfully transform these complex molecules into an inhalable dry powder. Bill? Thank you, Kirk.
spk06: Good afternoon, everyone. I am pleased to report that we have continued to advance the science and partner applications supporting thin-film freeze-drying. This includes strengthening our robust intellectual property portfolio. We have filed an international patent application based on our work on biologics and completed supporting work for three additional provisional patent applications based on our work on vaccines, adjuvants, and monoclonal antibodies. Our most recent research for providing stabilized powder forms of liposomes liposome-based compositions, adjuvants, adjuvanted vaccines, and monoclonal antibodies is key to further applications of thin film freeze drying to the stabilization and pulmonary delivery of vaccine antigens and monoclonal antibodies. We have continued to publish and file intellectual property around our innovative work in applying thin film freeze drying to the delivery of low molecular weight, hard to deliver drugs, as well as biologics. These activities are key to our continued work to differentiate, improve the advantages of our process and powder characteristics to therapy as enabled by the thin film freeze drying process. We were invited by the American Editorial Board of the journal Kona Powder and Particle Journal a high-impact, internationally recognized journal that publishes papers in powder science and technology. And we just published our paper titled, The Development of Thin-Film Freeze Drying and Its Application to Improve Delivery of Biologics as Dry Powder Aerosols. This is important recognition of our technology and its impact. Also, Our paper titled, Niclosamide Inhalation Powder Made by Thin Film Freezing, Multidose Tolerability and Exposure in Rats and Pharmacokinetics in Hamsters, was recently published in the High Impact Journal, International Journal of Pharmaceutics. And the paper's findings directly support the company's efforts developing inhaled dry powder niclosamide to treat viral infections including COVID-19. Lastly, our paper based on a research collaboration with Takeda Vaccines that began during a poster presentation at an AAPS PharmSci 360 meeting a couple of years ago was recently published in BioRxiv and recently peer reviewed by the International Journal of Pharmaceutics. This paper confirmed that thin-film freeze drying successfully transformed a liquid suspension form of a bivalent norovirus vaccine candidate adsorbed onto aluminum oxyhydroxide into powders by thin-film freeze drying without causing antigen loss or particle aggregation, all while maintaining the potency of the antigens within a specified acceptable range. Notably, we showed that the potency of the antigens in our dry powders was maintained in the specified acceptable range for eight weeks at 40 degrees C, 75% relative humidity in a completed stability study, thus confirming the potential to eliminate the cold chain requirement for transport and or storage of this adjuvanted vaccine. These findings have broad applicability to other adjuvanted vaccines that we are currently working on. Our technology validation efforts for applying thin film freeze drying to partner compounds has been robust, as highlighted by Glenn and Dale. At a high level, I'd like to describe some of those efforts. First, our work with Augmenta monoclonal antibody AUG3387 has confirmed that thin film freeze drying resulted in stable, inhalable dry powders suitable for dry powder inhalation. As recently confirmed, the antigen binding and virus neutralization activities of this monoclonal antibody in the powders were indistinguishable from the monoclonal antibody before being subjected to thin film freeze drying. These efforts will allow us to demonstrate that a sufficient dose of AUG 3387 to achieve a neutralizing concentration in the lungs can be delivered using an already approved commercially available dry powder inhaler device. I note that we are similarly validating other partner monoclonal antibodies with the goal of stabilizing and delivering them as dry powders. Next, we continue to validate applications of thin-film freeze drying to stabilization and delivery of partner mRNA lipid nanoparticles, including those for improving cold chain requirements and creation of dry powders for inhalation. These studies demonstrate the benefit of the intermediate freezing rate and very small interfacial area as used in thin film freeze drying, such as maintaining particle size of the mRNA lipid nanoparticles and the encapsulation efficiency, integrity, and function of the mRNA in the lipid nanoparticle as compared to those of spray freeze drying. which has high interfacial area and shear stress created during the atomization step. Next, we have applied thin-film freeze drying to various other partner peptides and proteins and confirmed their potency, stability, and deliverability as a dry powder, including those to improve storage stability and delivery by dry powder inhalation. I would like to acknowledge my colleague, Professor Jinrong Cui, for his continued commitment to our efforts to leverage thin-film freeze drying to solve drug delivery problems. I would also like to acknowledge the significant contributions of postdoctoral fellows Chehu Moon, Willie Sahakij Pijarn, and Haiyu Xu for their dedication and commitment during these most trying of times during COVID. I want to also thank the graduate students supported by the sponsored research agreement and technology validation agreements with TFF Pharmaceuticals for their scientific contributions upon which our platform is possible. Thank you all for your continued efforts in supporting TFF Pharmaceuticals. And now I'd like to turn the call over to Chris Cano, Chief Operating Officer, who can update you on more of the progress the company is making in its business development and partnership efforts. Chris?
spk11: Thanks, Bill, and good afternoon, everyone. Thank you for joining us today. As previously shared, the TFF business development team is focused on three key areas of growth for the company. These three key areas are, one, growing the TFF pipeline of internal development programs, two, our pharma partnering efforts, and three, our government and academic contracting efforts. We continue to make great strides in each of these key areas. For today's call, I will be focusing on the wide breadth of different modalities where the TFF technology has differentiated itself from other dry powder technologies. TFF continues to be very active in the mRNA space. We currently have 10 ongoing projects, and we are in discussions with other potential companies to discuss additional mRNA projects. This number continues to grow. We are working with pharma partners to formulate their proprietary mRNA into a dry powder. For some partners, we are formulating a dry powder for inhalation, delivering the dry powder mRNA deep into the lung to treat respiratory ailments. For other partners, we are formulating their proprietary mRNA vaccines into a dry powder to form a more stable vaccine that is not subject to cold chain storage and transportation. This dry powder is then quickly reconstituted for injection on site. Cold chain storage and transportation continues to be a tremendous challenge for many regions of the world. TFF also has many other nucleic acid projects underway, including formulating siRNA, oligonucleotides, plasma DNA, and other RNA compounds into our TFF dry powder. These programs predominantly focus on delivery of the nucleic acid formulated as a dry powder for delivery directly to the lung to treat different respiratory diseases. TFF continues to be very active in the monoclonal antibody space, formulating either MABs or FABs. We currently have eight ongoing projects and are in discussions with other potential companies to discuss additional antibody projects. The number of antibody projects is on the rise. As mentioned previously, we have made very good progress with our partner, Augmenta Bioworks, and we continue to build our expertise in formulating antibodies utilizing our innovative dry powder technology for delivery of these therapeutics directly to the lung. The TFF dry powder technology is differentiated when it comes to formulating both peptides and proteins. We are currently partnered with eight different companies formulating their proprietary peptides and proteins. The number of our vaccine projects continues to grow. We are currently formulating numerous vaccines, seven projects as of last month. We are currently in the process of negotiating with USAMRID in order to put a new CRADA, a Cooperative Research and Development Agreement, in place. We expect the CRADA to be signed over the next few weeks. This CRADA will progress one of our vaccine projects, into an animal efficacy study. TFF is also working with four different partners on their proprietary phage products. Again, by formulating a dry powder, which after testing reflects minimal titer loss and high viability, we can deliver active phage directly to the lung. On the government contracting front, we continue to work very closely with Leidos, the prime on the DARPA contract. This is the first government contract for TFF, and we are actively pursuing additional government contracting opportunities. With our academic partnerships, we continue to make very good progress. With Ted Ross at the University of Georgia, we are moving our universal influenza program into a second species of animal testing. We previously reported our results in a mouse immunogenicity study, and we are now moving into ferrets. With Kartik Chandran at the Albert Einstein College of Medicine, we are now moving our BSV program into animal studies. With Drew Weissman at UPenn, we are beginning our initial mRNA formulation work and have finalized our protocols for animal testing, which we expect to start in the next month. In summary, the TFFBD team has been making tremendous progress in our partnering efforts. We continue to grow the number of collaborations we have with pharma partners, and we continue to expand the application of our thin film freezing technology. The TFF pharma team is currently working with a majority of the top 20 pharma companies, and we have ongoing discussions with many others as we continue to expand our collaborative projects across the wide range of modalities. From an IP perspective, Building our patent portfolio is a key value driver and foundational component of the TFF corporate strategy. As of August 1st, 2021, TFF has 58 issued and or filed patents. Patent protection and exclusivity is interwoven into the fabric of everything we do at TFF as we grow our company and expand our technology. In closing, I would like to thank our partners at the University of Texas at Austin. With the continuing support and efforts of Dr. Bill Williams and his research team, we continue to expand the applications of the thin film freezing technology into new and innovative areas of drug delivery. The TFFBD team is focused on closing at least two signature licensing transactions in 2021. We are very well positioned to meet this objective and we continue to foster future growth opportunities for both our technology and our company. Thank you for your time today. Enjoy your evening. I will now hand it back over to Glenn.
spk02: Thank you, Dale, Kirk, Bill, and Chris. Let me conclude this call by saying that TFF Pharmaceuticals remains steadfast and confident in the progress we are making to build short, mid, and long-term value for you, our shareholders. We are making steady progress on our internal portfolio of clinical assets and producing strong data positioning these assets for meaningful value creation. Remember, we are a platform technology company applying thin-film freezing to both internal and external opportunities. Our business model has already created significant opportunities that are moving ahead with purpose with numerous and diverse partners. The team is intensely focused on execution of our existing programs, as well as delivering transactions on the business development front. My confidence level continues to grow on a daily basis. As always, we appreciate the support of our investors and partners, and we look forward to speaking with you next quarter. And with that, I'll turn the call back to the operator and open it up to questions.
spk08: Thank you. If you would like to signal with questions, please press star 1 on your touchtone telephone. If you're joining us today using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that is star 1 if you would like to signal with questions. And our first question will come from Jonathan Ashcroft with Roth Capital Partners.
spk10: Thanks a lot. Glenn, I was wondering if you can tell me about how your Greenlight agreement is going and how it might be energized by the recently announced act for Greenlight.
spk02: Hi, Jonathan. Hope you're well. We generally don't make a lot of comments about the partnerships. In this case, I can. We've had really good interactions with Greenlight. We've worked on their materials. We've produced some some really stellar results in formulation. And I'm actually quite excited about the fact that they've been able to gain financing so that this gives us an opportunity when we do get to the level of a transaction, we can do a meaningful transaction. We will not do deals where there's not meaningful economics. So having Greenlight funded is really a very, very positive step in the relationship with them so that's that's moving along and even looks better now that they're funded right so thanks for the question um also are you still confident in cannabis revenue uh third quarter this year yes jonathan so um you know you get one chance and one chance only to launch a consumer brand right so we have really done a lot of formulation work with plus And right now, I think we're at the point where we are in position to test these formulations and different put-ups with consumers. And once we have a good handle on what that reaction is, assuming there's no tweaks we need to make, we'll be ready to move forward.
spk10: Okay. Do I time for the third question, or should I get back in the queue?
spk03: Yeah, sure, Jonathan. Yes, you do.
spk10: By activities by year end 21 for VORI and TAC, do you mean patient dosing or some earlier activity?
spk03: Yeah, so, Dale, do you want to take that?
spk02: I don't want to, these are your trials, so I'll let you speak to those. Okay, Dale is the one that's, first of all, I want to compliment Dale. He's just doing, as is the whole team, Jonathan, an incredible job. If you look at, you know, the trials, the outcomes, the amount that we've been on time and on budget, I think it's time to give Dale and the team a real big shout out here. But Dale, you go ahead, please.
spk12: Thanks, Glenn. And thanks, Jonathan, for the question. So we are doing everything we can to push into scientific advice meetings and so that we can negotiate some of the endpoints and then get our regulatory filings in place. And unfortunately, you know, we're going to be doing our best to actually dose patients by the end of the year. But some of that is dependent upon regulatory approvals and how various countries handle those regulatory approvals is, you know, could be pushed back based on, you know, but But we will file for approval, and hopefully we'll have everything in place and be dosing. The other thing with all of these trials, as you know, is that even if you have sites activated, regulatory approval, drug on site, you may not end up with a patient ready to enroll. So we'll be doing everything we can to make sure that everything is in place, and we hope that those patients come this year.
spk02: Yes. So, Jonathan, it's in our headline, right? So, you know, we have some more, you know, we'll get the RAD data back from Bonvori. We'll publish the Phase 1 data report on TAC, and, you know, we intend to do everything we can, and we intend to be, you know, moving forward with the Phase 2's physical trials by the end of the year.
spk10: Thank you, Glenn and Dale.
spk03: Thanks, Jonathan.
spk08: And our next question will come from Jason McCarthy with Maxim Group.
spk01: Hey, there. This is Michael Akunowich on the line for Jason. Thanks for taking the question, and congrats on the progress this quarter.
spk03: Thanks, Mike.
spk01: So I'd like to ask just regarding the timelines and TAC and VORI, it looks like we're on track to enter those pivotal studies in the second half. If I recall, those are supposed to be relatively short, positioning potentially for filings in the first half of 22. Are we still looking at that timeframe? And then based on the enrollment you see in the phase one, how should we look at the timelines for data in those?
spk02: Yeah, so we believe that we'll have the interim analyses done in the first half, and the trials will probably now conclude in the second half.
spk03: of next year, Michael.
spk01: All right. Thank you very much. Thank you. And then, you know, going forward, it looks like, you know, we're pretty quickly approaching TAC and VORI crossing that finish line. So I'd like to ask, in your view, what comes next? It seems like much of the pipeline is in the form of your platform collaboration. So is this more so how we should think about the future of TFF, Or do we expect to get some additional internal pipeline compounds to come on board?
spk02: Yeah, great question. And it speaks, I think, to our strategy. So you're right. First, you think about the fact that Kirk mentioned that we do have significant capital that will cover the trials that we have planned. And Kirk's assumption here is also that that includes no, which is a really extreme assumption. no generation from our transaction. We plan on identifying other internal portfolio opportunities. If you look at our last transaction, it was a co-development with Augmenta. In that transaction, we agreed to share the costs of the preclinical and clinical work through phase one, and then look for a partner going forward. I'm not saying definitively that we do more transactions like that, but it could be some of those. It could be something we would take on by ourselves. But, you know, we are, as I said in the script, you know, we are a drug development company, and we'll develop those, you know, apply the technology to either internal assets or partners' assets, and we'll keep churning. So, you know, this is, I think, the quintessential short, mid, and long-term value creation opportunity here. And If you listen to Chris, you know, the partner programs are growing dramatically. We've increased the patent portfolio now to 58. I think the last time we reported it was 45. So, you know, this is just, you know, it's just really, it's just a creative every day in terms of how many more opportunities. But, yes, to answer your question in a short way, we will look to add to the internal portfolio either with partner programs or or programs that we would do by ourselves.
spk01: All right. Thank you very much. And then just one more for me, and I'll hop back in the queue. Okay. So sometime last summer, you were discussing a TFF formulation of remdesivir, and we haven't heard much on that recently. But the reason I'm bringing it up is because Gilead recently stopped developing their own inhalable remdesivir due to deposition challenges. So what I'd like to ask is, were you able to get lung deposition with your remdesivir formulation? And can this be thought of as a prime example of just how difficult dry powder inhalable formulation can be and the value of the TFF platform?
spk02: You know, I'm going to give this off to the man who did the work, and that's Dr. Williams. So, Bill, could you comment here? Yeah. Yeah, thank you, Glenn.
spk06: Yeah, so we have shown in multiple rodents, models, one of which was hamsters, and that's the preferred infection model for COVID. We showed very good deposition in the lungs, and we modeled it in the two papers that I, or the one paper I referenced in the script. So we believe we can do it. Gilead, to the best of our knowledge, was testing a liquid form, and it does, it goes to show you that These inhaled drugs, you know, they are difficult. The formulations are difficult. We spend, you know, every waking hour trying to figure these out. And we believe, you know, with the remdesivir, we nailed it. And, you know, up through animals at least. So great question and thank you.
spk02: All right. Thank you very much. That is a great example of just how broad the application is here. And You know, we actually think we've, you know, it has to be tested, right? But we solved their problem, at least in terms of getting deposition. Is it an effective therapeutic? You know, that only would remain to be seen here.
spk03: But, you know, Bill, I think, solved the formulation problem. Yeah, thank you very much. Thank you.
spk08: Thank you. And our next question will come from Mayek Mantani with B. Riley Securities.
spk04: Hi, good afternoon, team. This is Sahil Kazmian from Mayek. Thanks for taking our questions. Maybe just a brief one for Glenn. Kind of going off the last question, you know, nice to see the progress across the Takenbori programs and looking forward to see those trials start. But as you kind of think beyond that, it would be great if you could opine on any thoughts you had on the Philip Morris Vectura transaction that closed today, and how do you think about kind of expanding the platform, you know, into that consumer space, including your discussion with Plus Products, et cetera?
spk02: Yeah, so, Mayank, I mean, obviously, we've watched, you know, the Philip Morris interest in, you know, delivery companies. As I sit here today, you know, we're certainly – focusing on execution and moving our business forward. And, you know, we certainly would always be opportunistic, but more importantly, I think, you know, we're just going to, our focus is on creating value for the shareholder. If that moves on to some other opportunistic activity, so be it. I think some of the parts here right now are perhaps worth more than the whole, but that remains, you know, but I think that's getting closer. It's kind of catching up to it because, The whole is starting to look pretty good. So, you know, we just, you know, we come to work every day thinking about moving the needle forward and closing more partnerships, et cetera. So I think that's the best way I can answer that question. Did I answer the whole question or is there a second part to that?
spk04: No, no, that's very helpful. And then maybe just a quick follow-up is do you have any deal sheets that you're reviewing right now that you can talk about?
spk02: The answer is yes, and I can't talk about them. I don't think you'd want me to because, you know, we're looking to create meaningful economics, and hopefully these discussions will result in that. And, you know, when we have the deal signed, we'll report it. But we're at all levels with these partnerships that Chris described, you know, in vitro and vivo and term sheets.
spk04: Great. Thanks a lot. Thanks for taking our questions, and congratulations on the progress.
spk02: Thanks so much. I appreciate that. Say hello to my aunt for me, okay?
spk08: And our next question will come from Daniel Carlson with TW Research Group.
spk07: Hey, guys. Thanks for taking my questions, and congrats on the progress. First off, Glenn, on tacrolimus, the clinical PK data release so far shows that the drug can reach blood levels needed for systemic immunosuppression. And I'm wondering if you have reason to believe that you can lower the dose for lung transplant patients to a level closer to what is used in the other transplants like heart, liver, and kidney.
spk02: Okay.
spk03: I guess we ought to give that one to Dale. Dale, could you take that one, please?
spk12: Yes. Thanks, Glenn. And thanks, Dan, for the question. So, To date, you know, as you mentioned, we have the clinical PK data that shows that we can reach that upper limit, you know, the 14, 15 range with a low dose. We're getting about 80% bioavailability. In our 26-week toxicology study, what we've demonstrated is that we can achieve about three to four-fold higher levels of the drug, of Ticrolimus, in the lung tissue. compared to the blood. And so what that gives us is the ability to, you know, when you dose from an oral perspective or from an oral route, you have to push the blood levels high enough to get enough into the lung to prevent the rejection in the lung tissue itself. But because we have a higher blood level or a higher tissue level from the inhalation, we can reduce the blood level and still have that same or, you know, more in the lung tissue. And so we think that, you know, essentially this is like topically delivering it to the right, you know, right to the site where it needs for the immunosuppression. And then we can reduce the systemic level down to levels that would be protective of the kidney.
spk07: Got you. Okay. That's helpful. Thank you. Switching gears. Your augmented TFF lead has shown activity against the Delta variant, and I'm wondering if you've tested against the new Delta Plus variant that Fauci has mentioned recently.
spk03: Okay. Dio, I think that's going to be for you also.
spk12: Okay. Thank you. Again, a very good question. The Delta Plus that has been mentioned, it has the full complement of mutations that are in the Delta variant, but it's also picked up this K417N mutation. And that K417N mutation was also in the beta variant that was first identified in South Africa last year. And we already have data showing that OGG 3387 works against the beta variant. We have strong reason to believe that 3387 will work on the Delta Plus. And we're, you know, again, as each of these new variants emerge, it takes, there's a lag time in being able to get all the reagents to perform that testing. But that is something that will be coming up.
spk07: Okay, great. And then, Glenn, can you talk a little bit more about your relationship with Catalan?
spk03: Yeah, actually, I'm glad you picked up on that, Daniel.
spk02: So, you know, we're very pleased that Catalan is obviously one of the leading, if not the leading CDMO, especially in the area of biologics. So the fact that we have Catalan on board to help produce the Augmentumab is a great signal because they now become you know, a provider of manufacturing GMP materials and beyond that can help us satisfy the needs of our maturing, you know, discussions with partners, right? So, you know, there's an evolution here. We've never talked about manufacturing before, right? So we weren't kind of, except for our internal pipeline, which was satisfied with the relationships we have with CoreX and IRISIS and Xperia, but now you're into this, you know, whole sort of biologic sterile product environment, right, which is really being, you know, the genesis of that is all of the partnerships that Chris described, you know, in those categories. So getting Catalan on board is really critical because we need to develop, you know, capacity and expertise to, you know, start producing products as these products get into animal testing and beyond, especially even in the sterile environment. So, you know, to me, you know, in running this business holistically, you And looking at the life cycle and the evolution of the business, they're a great partner. And I think, frankly, to the investor, that should be signaling something. And it is. So I think that congratulations for picking up on that. I generally don't like to use a lot of hyperbole. But mentioning Catalyst, I think, is a signal to just where we are in the life cycle, especially on the biological.
spk07: Yeah, no, they're great. So congrats on that. And then one last question for me, if I could, is I know, you know, your vaccine work would help relieve cold chain issues. And a company that has been working over in Africa on some vaccines is Dyadic. And I'm wondering if you've done anything in conjunction with them at all. Okay.
spk02: Well, I... had permission from their CEO to say this. So Mark Amelfar is the CEO. I want to really congratulate Mark on his transaction with Sorrento, which again is good, I think, because it now gives Mark some capital to do some things. But we have successfully formulated his vaccine candidate. And I think it's just, you know, now we have the opportunity, I think, to really, hopefully, again, big hopefully, hypothetically, look at how and if we can move that project forward. Great. Okay. Well, congrats on the progress. We don't comment on who all these MTAs are with. Number one, a lot of companies don't want us to. In the case with Mark, because we are close with Mark, he said he would feel comfortable disclosing that we have a relationship with him.
spk07: Yeah. Okay. Well, thanks, guys. Appreciate it. I'll jump back. Thank you.
spk02: Okay, maybe we have time, operator, for one or two more questions, if there are any others.
spk08: And that question will come from Richard Deutsch with National Securities.
spk13: Yes, thanks for taking my call. And if you don't mind a little pun here, your presentation is just breathtaking. I've rarely heard such a detailed, broad, and incredible presentation before. especially for what you've done in the last quarter. It's phenomenal. I've got a couple of questions. First of all, I thought I heard you say out of the business deals that have been percolating for a while, did you say you actually put out finished term sheets that are under review right now?
spk02: We do have term sheets in place with some partners, and Richard, I just want to be really clear, it doesn't mean that we're going to get transactions done with these partners, but we are at the term sheet stage. Okay. And look, I wanted to say, Glenn, why wouldn't you do a deal? Well, maybe the economics won't be right, okay, or something happens in diligence, but yes, I want to put a big qualifier on that so people don't say, Glenn, you said you're going to get a deal done in two weeks. We do have some term sheets, and we are And that's good.
spk13: All right. Well, I mean, if you've got a term sheet out there that you're happy with, money is, it's all a matter of it going through there.
spk02: I'm not saying I'm happy with them either. We do have term sheets. Okay. Okay.
spk13: And the other thing is.
spk02: You can count on me and my team to, you know, get, if there's a deal to be done, to get it done in a value creating way.
spk13: Yeah. Well, if you give them the ring and all they got to do is accept, that's pretty much progress. One other thing, I've got a whole list of all your projects, which are, as everybody can hear, more numerous than anybody can deal with, but there's some very, very short-term things that are coming up. When do you expect or have you heard about orphan drug status for tacrolimus?
spk02: We actually have orphan drug status already for tacrolimus. That was, I guess, about a year ago or so that we We actually received, yeah.
spk13: Oh, then I misspoke. I'm looking for Vori then. Aren't you?
spk02: Ah, Vori. Yeah, we are in the process of applying for the orphan designation for Vora Council.
spk13: And what's the timeframe on that?
spk02: Yeah, I don't want to say specifically. Again, I don't want to give everybody a date because we're at the mercy of the regulatory authorities, right?
spk03: but it is something we're pursuing.
spk13: Okay. And you also had the GLP results coming. Are those going to be showing up soon?
spk03: GLP results.
spk13: Good laboratory practice.
spk03: Help me, Dale, or Bill, do we know it, Richard?
spk12: So we... Sorry, we do have GLP talk studies that have been completed and ongoing, and we also have good manufacturing. You know, we've been manufacturing to GMP for all of our clinical work to date. So, we are fully GCP, GLP, and GMP compliant for all of our work.
spk05: Wow.
spk13: That's just outstanding progress for a A company your size is incredible. Well, thank you very much. I appreciate your presentation.
spk03: Thank you, Richard, for your support.
spk02: Operator, maybe one more if there's someone else in the queue.
spk08: At this time, there are no further questions, sir.
spk02: Okay. Well, thank you, Operator. Thanks to my team. To all of those that are still on the line, thank you for your support. I urge you all to stay healthy. I want to tell you, be careful out there. My 11-year-old granddaughter is recovering from COVID, healthy young little girl. Thank God. But it's coming back, so be careful. I want you all to be healthy and well and happy. So thanks again for your time and your attention. Good afternoon.
spk08: Thank you. And that does conclude today's conference. We do thank you for your participation. Have an excellent day.
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