This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: Good day and welcome to the TFF Pharmaceuticals, Inc. first quarter 2022 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Corey Davis. Please go ahead.
spk14: Thank you, Operator. Hello, everyone, and welcome to TFF Pharmaceutical's first quarter financial and business results conference call. With me on the line today is Glenn Mattis, President and CEO of TFF, Kirk Coleman, Chief Financial Officer, 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. Press release announcing our first quarter results is available on the TFF Pharmaceuticals website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings released in this teleconference both include forward-looking statements, and 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 the disclaimer and in our filings with the U.S. Securities and Exchange Commission, including the risk factor section of our 2022 quarterly report on Form 10-Q filed with the SEC. And now it's my pleasure to turn the call over to Mr. Glenn Mattis. Go ahead, Glenn.
spk09: Thank you, Corey. Good afternoon, and thank you for joining us today to review the company's first quarter operations and recent highlights. During this call, I will provide an update on our overall progress, then ask our Chief Financial Officer, Kirk Coleman, to review our first quarter financials. Having announced our fourth quarter and year-end 2021 results just a few weeks ago, we decided to provide a more focused formal commentary of our meaningful progress for this call. This will leave more time for Q&A, and please note that Chris Cano, Dale Christensen, and Dr. Bill Williams are present on today's call and will participate in that session. PFF continued to build strong momentum in our pipeline and partnership activity in the first quarter of 2022, and this momentum carries over from our very successful fourth quarter, which saw numerous accomplishments, including the final data from the Phase Ib study of inhaled voriconazole powder in asthma patients and the initiation of our Phase II studies for both inhaled tacrolimus and voriconazole powders. In addition, we began the Phase I inhaled niclosamide powder study in Canada to treat COVID-19. Advancement of our pipeline programs continued in the first quarter. CFF continues to progress with the inhaled voriconazole and tacrolimus inhaled powder Phase II programs. Both Phase II studies will produce interim analyses late in the third quarter of this year. This is a key milestone event as these data will be shared with potential pharmaceutical company partners in a licensing process. That process has been initiated working with Torea Partners to introduce the opportunity and invite interested companies to begin diligence. We have established a comprehensive data room and already have potential partners performing diligence as a result of inbound interest. EFF has also made voriconazole inhaled powder available on a limited compassionate use basis when requested by investigators. We have received very positive feedback on the first of these patients on Monday. The treating physician shared results with us that supports the efficacy and safety target product profile for voriconazole inhaled powder. In general, this patient was considering only palliative care for his disease and now has reported outstanding efficacy and safety. Dr. Dale Christensen will be happy to share more details should you have questions during the Q&A. CFS also advanced the inhaled niclosamide powder development program. After completing enrollment in the 40 patient phase one study earlier in the quarter, in April we announced positive safety and pharmacokinetic data showing that niclosamide inhalation powder was well tolerated with no serious adverse events across all subject cohorts. Importantly, the study also helped us identify what will be the optimal dosing level for the product in the Phase II program. At the 6 milligram dose level, niclosamide inhalation powder is estimated to produce a concentration of 10 micromolar in the epithelial lining fluid in the lung, following delivery as a dry powder. which would be considered highly potent with respect to inhibiting viral replication. A single administration of 6 mg of niclosamide inhalation powder to the lungs provided equal mean maximum drug concentration, or CMAX, in the blood as 100 mg, delivered as a nebulized spray to the lungs and nasal cavity, as demonstrated in a recent publication. Furthermore, the study's safety management committee also expressed no questions or concerns about the safety and recommended the 6-milligram BID dosing as safe for progression into Phase II testing. Further highlighting the product's potency, in February we announced the results from recently completed in vitro and viral replication assays, which showed the niclosamide inhalation powder completely inhibited viral replication of both the Delta and Omicron variants of SARS-CoV-2. The results also showed that our inhaled niclosamide demonstrated complete inhibition of Omicron replication in only one micromolar compared to the Pfizer and Merck antivirals that each showed complete inhibition of Omicron at 2.5 micromolar. In our view, the high potency of inhaled niclosamide powder suggests that the product may have major advantages over oral delivery, including improved safety and tolerability. The program reflects the exact type of value we hope to create in every one of our collaborations, which dramatically improve drug delivery so that an optimal amount of active molecule can be delivered while minimizing potential side effects to the patient. We continue to develop niclosamide inhalation powder in partnership with Union Therapeutics as a potential antiviral to treat COVID-19 and other respiratory viral diseases. Union Therapeutics is now evaluating the data DFF has generated for a niclosamide inhalation powder, which will inform the decision on the option to assume responsibility to further develop the compound. New and disruptive technologies are often supported by a steady stream of basic research and development, which over time leads to a significant body of scientific literature, and this is clearly the case with thin-film freezing. At this year's RDD meeting, Dr. Bill Williams and his colleagues at the University of Texas at Austin presented five separate papers highlighting the versatility of thin-film freezing technology. These data also support the differentiation of thin-film freezing from other methods to create dry powder, particularly in biologic. In fact, one of the papers, which explored the use of machine learning algorithms, to analyze how thin-film freezing impacts aerosol delivery of dry powder therapies. It received a poster on the podium recognition. The research being conducted by Dr. Williams and his colleagues to demonstrate the versatility of this unique innovation in pharmaceutical formulation development, and we look forward to highlighting additional research from our laboratories as they become available. Turning our attention to our collaboration activity, DFF announced a strategic partnership with the global CDMO Catalan during the first quarter. The client base of over 1,000 companies, we are confident in the short, mid, and long-term productivity from this relationship. In particular, Catalan will introduce thin-film freezing to a targeted list of potential licensing candidates. And with Catalan's focus on biologics manufacturing, provide a clear path forward in providing a source for product in this key arena. This matches very well the balance of TFS partnership portfolio. I'm happy to report that TFS and Catalan have been working very well together to successfully launch the partnering effort, and I look forward to reporting multiple successes as we work together. During the quarter, we were also pleased to announce a second cooperative research and development agreement with the United States Army Medical Research Institute of Infectious Diseases and the Geneva Foundation. We consider our partnering activity in the government, defense, and other public-related sectors as a core area of focus for our business. And, as applications of thin film freezing continue to expand, we anticipate that our public sector collaborations should provide a significant source of non-dilutive funding over time. Speaking of non-dilutive funding, TFF continues to work to capitalize on the language in the omnibus budget legislation, which highlighted the opportunities created by thin-film freezing. We are working through supportive groups to fully explore funding opportunities. Now, looking at progress on other existing collaborations, TFF is continuing to work with Plus Products, who recently announced a transaction with Glasshouse. this transaction will build a highly competitive company in the cannabinoid space. As this partnership is freshly minted, we are in discussions on a path forward on the TFF inhalation cannabinoid products that have been successfully tested with consumers. And finally, we are working with our development partners at Augmenta to identify next steps for Augmenta 3387, which has been identified as a highly potent monoclonal antibody to treat COVID-19 in preclinical animal models. In general, based on the robust pace of our ongoing partnership work and discussion, we remain highly confident that 2022 will see TFF Pharmaceuticals enter into meaningful, monetized new collaborations while expanding many of our existing partnerships. The number of companies in our portfolio continues to grow, and the work we are doing under open MTAs and statements of work continued to progress with successful scientific results and extreme purpose. The first quarter also saw TFF Pharmaceuticals bring in a wealth of new and diverse talent in the form of senior level and board of director appointments. As the number of collaborations grow and our internal clinical programs advance, an appropriate level of investment is required to optimize such growth. The new colleagues added to TFF Pharmaceuticals reflects a company fast becoming stronger across all facets of our business. We believe these additions will lead to the expansion of existing collaborations, the forging of new and more strategic partnerships, and the advancement of multiple programs into late-stage testing, all of which will generate significant value for our shareholders. And with that update, I will turn the call over to our Chief Financial Officer, Kirk Coleman, for review of the financials.
spk00: Kirk? Thank you, Glenn. For the three months ended March 31st, 2022, research and development expenses for the company were $5.3 million compared to $5.3 million for the same period in 2021. General administrative expenses for the three months ended March 31st, 2022 for the company were $3.2 million compared to $2.6 million for the same period in 2021. The company reported a net loss for the three months ended March 31st, 2022 of 8.4 million compared to a net loss of 7.7 million for the same period in 2021. Weighted average common shares outstanding, basic and diluted for the three months ended March 31st, 2022 were 25,371,781 compared with 23,140,607 for the same period in 2021. As of March 31st, 2022, we had total assets of approximately 33.8 million and working capital of approximately 29.3 million. At the end of the first quarter, our liquidity included approximately 26.4 million of cash and cash equivalents. And with that, I'd like to turn the call back over to Glenn.
spk09: Thank you, Kirk. Since our last call only a few weeks ago, market conditions have clearly not improved. What hasn't changed is the pressing need for pharmaceutical companies to develop significantly improved drug formulations that can be more safely and efficiently delivered to patients. The work we are doing at TFF Pharmaceuticals to address this significant demand places our company in a unique and, in my view, quite enviable position. From the research being conducted at the university benchtop all the way through to the progress we are demonstrating in the clinic, And through our partnerships, the value being created by our thin-filling freezing technology continues to set new high watermarks quarter after quarter. Without question, we believe our technology represents a true breakthrough in formulation technology and one that the industry has been seeking for decades. As investors attempt to reconcile the latest short-term market conditions against TFS' demonstrable progress, we can only provide our shareholders with the assurances that our company will continue to work diligently to maximize value across every facet of our business. This quarter, we did exactly that by signing a strategic collaboration agreement with Catalan, entering our second crater agreement with Samrid, and announcing positive data from yet another clinical stage pipeline asset with inhaled niclosamide powder. And we expect this steady cadence of pipeline progress and collaborative activity will continue throughout the year and beyond. I would like to thank all of the TFF employees and key consultants for their contributions to the company. I'd also like to thank the board and our shareholders for their support. And with that, I will turn the call back to the operator and open it up to questions. Operator?
spk01: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. And the first question today will come from Jonathan Ashoff with Roth Capital Partners. Please go ahead.
spk06: Thank you, and congrats on the progress, guys. For one of your internal programs, can you provide any details about that TFF for a compassionate use patient, you know how they did, and will you be treating any additional compassionate use patients?
spk09: Yeah, hi, Jonathan, this is Glenn, and to all of you that are asking questions, I will either answer the question or ask one of the members of the TFF team to respond to this question, and I actually... really appropriate because Dale's been the one that's been really working these programs personally with all of them in vigor. I'll let Dale to answer the question.
spk12: Thanks, Glenn, and thanks, Jonathan. So we received an update on this patient. The patient has now been treated for 11 weeks. This was a patient who had spent six months out of the last year prior to starting the compassionate use study. in the hospital as an inpatient getting IV antibiotics and antifungals when tolerated. The patient had experienced every side effect that could be imagined from antifungal therapies. and was essentially ready to give up treatment and go home. And they were discussing palliative care when the idea of treating him with the inhaled Voriconazole came along. In the immediate aftermath, the patient has now been outpatient, taking the inhaled Voriconazole for 11 weeks. He has seen stabilization. He had lost approximately 40% of his FEV1 lung function. And in the 11 weeks, he's lost less than 3%. So it's stabilized on lung function. His forced vital capacity has increased over that time. And the patient is considered clinically stable for the first time in well over a year. In addition to that, you know, One of the things that we speak about as the positive benefits of the inhaled boriconazole is minimization of drug-drug interactions. And this patient who was on tacrolimus to maintain his immunosuppression, this patient has not had to have a dose adjustment to his which would have had, you know, if he had taken the oral Voriconazole, there would have been major dose adjustments required to achieve levels because of those drug interactions. So all in all, the results from this one patient are exactly why I went into this business, to improve people's lives, because this person has truly benefited from this therapy.
spk06: Thank you, Dale. So as you guys look at all the preclinical and the phase one results with BORI and TAC, you know, what are your key takeaways and what do those takeaways signal about the probability of success in these ongoing pivotal phase twos?
spk09: Yeah, so thanks. So I think let me just ask from a business perspective, and, Gail, I'll probably give you a minute or two to think about your response. So as you know, Jonathan, and I think most of you who know the company, with our data that we've gleaned from the phase two trials leading up to probably the latter part of the third quarter, we think that will certainly be, you know, based upon the phase ones and based upon what we're seeing from the phase 1B, and now I'll be at one compassionate use patient and hopefully more. You know, we think that that'll be the final piece of the puzzle to attract patients interesting companies to bid on licensing the product. And we've engaged Torea Partners. I work with Torea. They're a really outstanding firm. They do this kind of work, place one or two assets in company with meaningful economics. So certainly from the business and revenue standpoint, this is a big piece of how we look at our capitalization. Now, from a clinical perspective, you know, I believe, I've always believed that The probability of technical and regulatory success here was extremely high. Dale, maybe the perspective you can supply is, in actuality, how is Warrington TAC performed against the clinical expectations you had? And whatever other comments you have, please feel free to add.
spk12: Thanks, Glenn. So, Just to take one step back, we selected the voriconazole, the TAC, and the niclosamide for the internal development programs because each of them is a validated drug, you know, best in class. You know, in the case of tacrolimus, it's already used for 90% of lung transplant patients. But the problem is significant toxicity when delivered by oral because you have to push up the levels to get enough into the lung to be effective. Similar message with Voriconazole. In order to get enough into the lung where it can be effective, that comes along with systemic toxicities. And so in each of these cases, the premise has been we can deliver the drug effectively to the lung, reduce the toxicity, and avoid drug-drug interactions by direct topical delivery to the lung. And so all of the non-clinical and clinical data that we've generated to date fully support that premise. As I just mentioned, the patient that is on tacrolimus and went on inhaled voriconazole saw no need for dose adjustment, which, you know, that is one of the key premises of this, that it will be easier for the patients and the physicians to use because there will be limited drug-drug interactions. And, you know, we fully expect, and I think we're seeing, you know, that the drugs can reach efficacious concentrations. And so in all cases, the programs, as we've advanced, they're performing exactly as expected. And some of the results are, you know, It's hard to say better than we expected because we have high hopes, but they're performing very well, and we look forward to generation of the final data and seeing this truly benefit patients in the future.
spk06: Thanks, Dale. Does a union actually have a right to opt in that they have not yet made a decision on, or is that included?
spk09: So, as you know, Jonathan, we finished the phase one trial. We delivered all of the available information to them from those trials. There's still some data, final tables, case reports that were sent in, but in essence, they do have, we believe, enough information to begin their diligence. In fact, we did get a list of diligence questions from them this morning. I went directly to Chris. We speak to them all the time, Yeah, I would say certainly their option deliberation period has commenced. And you are correct, they have an option. And if they exercise that option, they will take over the development of niclosamide.
spk06: And when you said has commenced, it sounded a bit formal. So they have a formal time by which they have to say yes.
spk09: I mean, if you go by the letter of the agreement, yes. I think practically it's commenced. By the letter of the agreement, we have to have a complete case report for them. I believe they've had enough information to begin actually the option period. I don't think people should be doing a countdown here for a rocket launch, but in my feeling and the company's feeling, the option period has begun.
spk06: Thank you very much, and good luck with partnerships that result in some upfront non-dilutive cash. Hopefully sooner than later.
spk09: Very optimistic.
spk01: Thank you. Thank you. And the next question is from Daniel Carlson with TW Research. Please go ahead.
spk16: Hey, Glenn. Thanks for taking my questions. First one is kind of a two-part one here. just about the general market conditions. I'm wondering if you've noticed that progressing your deals has been impacted at all by this. And then that leads to the second part is maybe you can update the status of the VORI and TAC out licensing process and the timing around that.
spk09: Sure. Daniel, we have not noticed and, you know, obviously you can't help but notice what's happening in the marketplace. But, you know, and I'll ask Chris to confirm this or not, but I don't think that the market conditions have really slowed down any of the work that we're doing. So many of the partnerships, and by that I mean the open MTAs and statements of work, have been going on for some time with those companies that we believe are close to transacting. If anything, I would say some of the smaller companies, and there aren't many in this list for us, where they're obviously now more acutely concerned about cash, I think it does come up, but it also hasn't slowed down the pace of any of the work we're doing. It hasn't slowed down any of the pace of the negotiations. It hasn't changed any of the numbers that have been exchanged or what the asks are. Chris, do you feel any color to add to that?
spk05: Yeah, no, thanks, Glenn, and thanks, Dan, for the question. I have not seen a slowdown due to market conditions for engagement with collaboration partners. There hasn't been an impact to us.
spk09: Yeah, if anything, if you want... I was going to say, do you want to talk?
spk05: Go ahead, go on.
spk09: Go ahead, Chris.
spk05: You know, I was going to say with the timing on the BORI and TAC, Dan, so right now, we're in the preparation process. So as Glenn mentioned earlier in his comments, you know, the phase two interim data is really a key milestone, right? So right now we're doing, we've, you know, from a process standpoint, we've done all of our work. We've engaged with TREA. They're representing us in this process. We've compiled all of the diligence materials in a data room. That data room is, you know, Currently, we do have potential partners in the data room performing diligence right now. We've also assembled a comprehensive list of potential partners that we'll be reaching out, and it's really all focused around delivery of the Phase II interim data.
spk10: Gotcha.
spk09: Yeah, we'll take that in practical. I think, I don't know how many, we're trying to get away from the numbers, but in the last couple of weeks, you know, we've opened up. a handful of new, just in the last couple weeks, new MTAs. And as I think about it, they're like mid-tier. So the pursuit of the technology as an opportunity to reformulate or do formulation doesn't seem to be diminishing at all. And just in other words, most of our work is on NCEs. It's not on reformulation. That also, I think, makes us a little bit more bulletproof. And look, I'm sorry to do this to you, Dan, but I can't help but also say, look, you have to think of TFF as a platform technology company. We're not a biotech company. Biotech companies have 100% chance of spending money on studies. Our platform technology has value and will bring in revenue. And I think that speaks a little bit to how we're being treated perhaps a little bit unfairly in the marketplace. And I get it, but I just couldn't help with saying it. So sorry, Dan.
spk16: No problem. That kind of segues nicely. So a question for Dr. Williams. I'm just trying to, if he could help me understand the significance of the data that he presented at that conference last week, that'd be great.
spk07: Yeah, thanks, Dan. And hello to everyone. So the data at the RDD meeting, we had five presentations, and we were able to present on different applications of jacrolimus, boriconazole, some of our new work on biologics, the plasma DNA work. It was very well received, and in fact, I was in several other presentations during the time, and now the Thin Film Freezing Platform is regularly referenced by other speakers in the same breath that they're talking about some of the competing technologies. So, that's really good. So, that was the context of the presentations throughout that meeting.
spk16: Great. Thank you. And then, Glenn, one last question for me, just kind of related to the union and the clozomide. Maybe you can talk about the potential for the clozomide beyond COVID-19.
spk09: Sure. So I just have also, to the conference bill reference, I mean, Catalan made a presentation on their work and included a big chunk about TFS. That was really nice to see. So, you know, we think there's a tremendous amount of potential for niclosamide if it's a potent antiviral. I'll have Dale speak about scientifically and clinically why. But to validate that, we are doing an extensive deep dive strategically into what those viral infections are that would pose the most opportunity. We went into the exercise thinking perhaps RSV and VSV, but we're also broadening that horizon. We've engaged a group to work with there that's helping us with the analysis. We're looking at pricing, we're looking at the IP, if there are any around what we would have. We're talking to payers. So to sort of validate the scientific and clinical hypotheses, we're also doing a deep strategic dive to understand what's our best path forward. We'll have those data in the next two to four weeks to go along with Dale's working up what clinical trials might look like, costs for that. So we have a good... understanding of not only important clinical significance might be, but what the business opportunity might be. Now, do we go out after this on our own? Well, right now, Union would have the options first for that. And, you know, we also think that these data will be helpful to Union to see to help them deliberate their path forward in the outcome.
spk16: Great. Thanks, guys. I'll jump back in the queue.
spk09: Okay. Oh, wait, Dale, you want to add some... critical commentary on those as well?
spk12: Yeah, so there is published information out there that has existed for a while showing that Nicosamide is a broadly active agent against all coronaviruses with activity against the MERS coronavirus that came out in the Middle East area, as well as the original SARS coronavirus that emerged in the 2004 to 2006 timeframe. And in addition to that, it has been published as a 22-nanomolar EC50 against RSV, and it was clinical isolates of both RSV-A and B-type strains. It's a broad-acting antiviral against these respiratory viral pathogens that cause viral pneumonias. And so we think that there's a high degree of, you know, ultimately, you know, the vision would be that a patient experiences a severe upper respiratory infection that could be viral. They call their doctor and they get this. And it would be the amoxicillin of antivirals for respiratory infections.
spk16: Gotcha. That's helpful and maybe available for the next COVID-22 or whatever. So, perfect. All right. Thanks, guys. Appreciate it. Thanks, guys.
spk01: And our next question is from Mayank Memtani with B. Reilly Securities. Please go ahead.
spk03: Hi. Good afternoon, Tim. This is Sahil on for Mayank. Congrats on the quarter and all the new additions to the team. Quick question on the two internal programs first and then a quick follow-up. Could you remind us of the enrollment targets for each of the trials and then what the interim analysis looks like in terms of the endpoints on safety and efficacy that you plan to report?
spk09: Dale, if we decide to disclose those, you would know. If we have, you can disclose.
spk12: Yeah, so we haven't disclosed the enrollment targets. So I'll speak more to the interim analysis. Essentially, both of the studies are open-label studies. As you can imagine, when you're doing a comparator between an oral and an inhaled therapy, and especially when the oral therapy can require dose adjustment to hit a target blood level, it is really difficult to think about how you blind that. So we are using completely objective endpoints. things like overall survival, those requirements for dose adjustment, discontinuation due to, you know, going on to salvage therapies, as well as things like, you know, in the case of voriconazole chest CT scans and, you know, looking at the cultures to see if we're clearing the lungs of the fungus. all very clear objective endpoints and therefore, you know, we can do open label because the more objective your endpoints are, the more accepted an open label type trial is because you don't have that, you know, kind of judgment involved in determining an endpoint. And so the, you know, the interim analysis there will generate Things like the differences between the oral and inhaled and treatment failures that required salvage therapy. We'll also be looking at, as mentioned before, drug-drug interactions because many of the patients in this study are going to be on tacrolimus or other chemotherapy drugs that are interacting with CYP3A and therefore would require drug-drug interaction monitoring. And so it'll be the proportion of patients that had to have their other concomitant medications adjusted due to the introduction of the voriconazole. And overall safety and then overall, you know, kind of stabilization from a clinical perspective, how many patients. How many achieve essentially clearance of the fungus from the lung? How many achieved reduction in chest CT scan infiltrates? So those are the things that will come out of the VORI trial. In the TAC trial, again, it's open label and it's all one-armed. because the patients that are going into this study are all receiving oral tacrolimus but are experiencing significant kidney toxicity to the point that their physicians are contemplating either drug holidays or significantly reduced doses of Voriconazole to try and spare the kidneys. So we will be looking at the stabilization of kidney function. Can we see that we either stabilize, stop the increases in creatinine or reduction in GFR? and does it stabilize or can it even improve? And then from the efficacy standpoint, we are looking at several different markers using different biomarker techniques from endobronchial biopsies that can tell us if there's signs of acute rejection going on in the lung. So we'll be able to compare the continuation of effective immunosuppression and prevention of rejection in the lung along with stabilization of the kidney function.
spk02: Excellent. Thanks a lot for that extra color. That's really helpful, and looking forward to the analysis at the end of the third quarter.
spk01: Thank you. And the next question will be from Anthony Plogesma, a private investor. Please go ahead.
spk15: Hey, Glenn. Thanks for taking my call.
spk09: Yeah, thank you.
spk15: I was wondering if you could give us the status on the Augmenta program and then follow it up with any updates you could give on the UGA, ACOM, and UPenn.
spk09: Okay. I'll give you an over-the-top on the Augmenta program. And as you know, we have been really enjoying our work with Augmenta. They're a very unique and innovative company. We've taken the 3387 molecule from the development. We've looked at potency in animal models against SARS-CoV-2 and its variants. And it's all been very successful. We've seen positive binding. We've seen positive neutralization. The neutralization that we've seen in the Omicron variant has certainly not been at the same level that has been seen with the other variants. This is a common theme, as you know, in what monoclonal antibodies have become in the overall armamentarium to treat COVID. We have a number of, I think, very creative ideas in terms of how to continue to develop augmented 3387. It is a bit of a right turn from where we're headed. I don't want to share those ideas because I think they're very unique and we don't want to tip. what we've come up with to the rest of the marketplace. We are working with one of our scientific advisory board members to help us craft that strategy. Diel, I don't know if you want to add anything to that, but we still believe in augmented. We still believe in a compound. We think we have something that has clinical value, and we also believe that there's a need for monoclonals in treating COVID-19 today and tomorrow. Dale, I don't know if you want to add to that or not.
spk12: Yes, thanks, Glenn. As Glenn pointed out, part of our commitment is to monitor ongoing and emerging variants as they occur and looking at the activity. As we proceed, we are testing against various emerging variants and ensuring that it works. And as you've seen with the Omicron variant, there's been, and especially with BA.2 now, Every commercial antibody that's already been given EUA has either had the EUA removed or revoked. And so, you know, it's a difficult place right now for antibodies in the Omicron world. And so we're still assessing all of that activity.
spk10: Okay. Thank you. Okay.
spk09: Can you repeat your second question?
spk15: It was on if you could give any updates on the work you're doing with UGA, UPenn, along those lines. Sure. Chris?
spk05: Yeah, sure. Thanks, Glenn. So on our academic collaborations, you had mentioned UGA, Albert Einstein, and UPenn. So I'll take them one at a time. So we're working with Dr. Kartik Chandra at Albert Einstein. We've successfully completed our in vitro testing of our dry powder. And we're in the process of conducting a large in vivo study with their VSV for COVID. We're performing an efficacy study in hamsters. And this study is being done and performed in collaboration with the researchers at USAMR and the Geneva Foundation. So very excited about the work we're doing with Dr. Chandram. in collaboration with Dr. Ted Ross at UGA. So we've prepared dry powder versions of their universal influenza vaccine. That's the one that has Ativax as an adjuvant. And so we've completed in vitro testing and in vivo testing in both mice and ferrets on our dry powder vaccines, right? And that allowed us to confirm that our dry powder preparation maintained the immunogenicity and efficacy. Our dry powder performed very well. We're in discussions with UGA and NIAID on clearly defining next steps on advancing our TFF dry powdered version of their universal influenza vaccine and how into the clinic. For UPenn, our collaboration with Dr. Drew Weissman, we've completed our initial mRNA formulation work. We've identified our lead optimal formulations. We finalized our protocols for animal testing. And we're preparing to deliver our TFF dry powder samples to Dr. Weissman so that they can commence these animal studies in the very near future. So we continue to push very hard on all of our academic collaborations.
spk10: Excellent. Thank you.
spk01: Thank you. And the next question will be from Richard Deutsch with National Securities. Please go ahead.
spk11: Yes, thank you for taking my call. There's almost too broad a landscape to have to get into one call. I sympathize with people trying to get specific, so I'm going to just ask one question and come back and see if you have enough time to get to a couple of them. But you did just announce another major commercial partner, which is Aptar. which if people don't know them, they're on the New York Stock Exchange and even on this market conditions, they're a $6.8 billion major corporation. They've been in business commercially successful. Can you tell us a little bit about what this partnership means and you know, uh, how they, uh, decided to move forward and, uh, what their, what, what their milestones and what they're looking to do, uh, over the next, uh, you know, uh, six to 12 months.
spk09: Well, first of all, thank you, Richard, for, for noticing that we did, uh, put out a new corporate presentation and I guess Richard and doing his diligence noticed that I went out or all commensurate with the press release, but I love, uh, Chris gets all the credit for this one. So, uh, as he does, frankly, for all the transactions. So I'll have him give you the details there.
spk05: Great. Thanks, Richard. So really excited about our partnership with ADTAR. This is a new initiative. So the concept is formulating our TFF dry powder for use in an intranasal device. So TFF working with ADTAR and using their proprietary intranasal device. So we're running some initial experiments, and if these initial experiments prove successful, we believe that, you know, our TFF dry powder brings unique attributes, right, for nasal administration. And this is not only for vaccines, but also for therapeutics. So depending on the compound and the disease state, this could be very advantageous for both patients and prescribers. So the way that it's structured is many of the Aptar customers are looking for a dry powder intranasal delivery, right? And at TFF, we're fielding very similar inquiries from our partners. Can you deliver intranasally? So the concept is marrying our respective technologies, the TFF dry powder technology with the Aptar proprietary device, and then we can drive our collaboration to address each of our respective customers' needs. So again, as I mentioned, it really depends on the compound and the disease state, but a dry powder intranasal spray could be very advantageous for delivery of vaccines and therapeutics. So it's really proof of concept. We're doing some experimental work right now. So I look forward to sharing the progress as we continue down this road with that talk. So thanks for the question.
spk09: It also really is synergistic with the Catalan partnership. We, as a team, had the opportunity to visit just a couple weeks ago their site in Boston, which is an inhalation site, and they're doing nasal work as well. So we anticipate that we're going to get a lot more opportunities to work in the intranasal space. And the Aftar relationship could not come at a better time. So this is all coming together quite nicely. Operator, next question, please.
spk01: Sure, and that question is from Ted Ketterer with TK Associates. Please go ahead.
spk13: Hi, guys.
spk01: Hi, Ted.
spk13: Glenn, to be very candid, the elephant in the room is your balance sheet and what, three-quarters of cash? And so far, no progress in terms of any incoming revenue. My question is, are we going to get diluted at $2 a share? Or are you guys, is something going to happen that's going to put your balance sheet in a position where the people who scout the markets for companies that are going to run out of cash short it and depress the stock? The rest of what you're doing is fabulous, but the fact of the matter is, okay, you're a company that's got, what, $8 million a quarter in expenses, and you're adding, it sounds like you're adding expenses with three new people and five new partners.
spk09: Okay. Well, Ted, just to correct you, we capitalized through the mid part of next year, almost through August. So we have more than nine months We believe we're very well capitalized. You know our business model. And I'll leave it at that. We're well capitalized. We manage our budgets extremely well. And I have nothing else to say than that. We've talked about our business model repeatedly. I've said on this call that we are extremely optimistic about our ability to close transactions with meaningful revenue.
spk01: Thank you, sir. And the next question will be from Leo Saraceno with Washington Capital. Please go ahead.
spk04: Hi, Glenn. I got a question regarding your open MTAs. Would you be able to break down what percentage of the The MTAs are biologics versus vaccines, mRNA, MABS, et cetera, along those lines.
spk09: Okay. I'm going to put my friend Chris Cano on the spot here. I bet he knows, but he may not know offhand. So, Chris, if you could try out, please do.
spk05: Sure. Thanks, Leo. Thanks for the question. So if I take a look at all of our ongoing collaborations in our different MTAs, we have a tremendous focus on biologics. So of all of our different MTAs, over 87% of them are really focused on biologics. And as Glenn had mentioned earlier, all of these biologics are NCEs to our partner or to the originator of the technology. So if I had to What I can share with you, Leo, is more of these collaboration projects, right, we're focused on biologics over 87%. Well, of that, 65% of these projects are oral inhalation, right, as the primary route of administration of our dry powder versus 30% of our projects, which are more of a stable dry powder for reconstitution and injection. as the route of administration. We have a couple of other projects which have alternate routes of administration. But by and large, there are a large number of projects that overlap. So we're working with partners on a dry powder vaccine. And the second project with that partner is an oral inhalation. And now with our new APTAR engagement and arrangement, based on demand, we're now looking at intranasal delivery of our dry powder. So hopefully that addresses your question, Leo, and gives you a little context of where our focus is and where our MTAs are. Great. Great, Chris. That's very helpful. Thanks.
spk09: We probably have time for one more question. Is there any?
spk01: Yes. Then our final question will be a follow-up from Richard Deutsch with National Securities. Please go ahead. Yes.
spk11: Thank you again for You did mention in your presentation that you had interacted with Glasshouse, which has finally purchased Plus Products. Can you give us a little bit more of an update on how soon we might see a decision on commercialization? I just want to make one comment about Ted's question about running out of money. Obviously, your business plan has monetization of TAC, VORI, niclosamide, the cannabis products. The government programs themselves evolve into higher and higher levels of product development and thus inventory purchase. Those alone would be enough to start a separate company. So I just wanted to throw that in there as Ted's comments seem to be you know, out of line with the reality of what you've done putting all of these products into final stage, you know, over the last year or two.
spk09: Yeah, thanks for the comment, Richard, and other opportunities, clearly. Specifically, you know, look, we have what we believe, first and foremost, Richard, our go-to-market assets, our formulations, and I have to really, again, I said this call after call, you know, Plus has been a remarkable partner to us in helping us develop these go-to-market assets. They've helped us test them in the marketplace. Congratulations to Plus for culminating their restructuring with Glasshouse. The feedback I have from the Plus management is that Glasshouse is interested, certainly, but we have, in all this time, we have contingencies in place to get our compounds to the marketplace as quickly as possible. Everyone we've talked to is very impressed with our compounds. As I said, we will hopefully do this through Glasshouse. If not, we have contingencies. We are excited about the opportunities here. Our goal is to get the first commercial sale as quickly as possible. Realizing, look, that the plus situation didn't help with timing, but we used that time productively, and we've got a really terrific array of formulations to take into the marketplace. I just want to, before concluding, I personally want to revisit the answer I gave on the union. You know, the option... period is clearly engaged. And the reason we're doing the work to look at how big the opportunity is for niclosamide, that's in the spirit of a partnership. I mean, unions doing all the work that they're doing to understand and be sure that we make the most out of niclosamide. We saw an opportunity in the work that we're, the partnership in bringing our intellectual views and then opportunities with refined numbers so that the partnership makes the right decisions. That's all I'm indicating there. So there's nothing other than what is in the agreement. We have great data out of the Phase I program, and if anything, the glycosamide opportunity has gotten much larger than we first engaged with Union or first started doing the work with Union. So I'll end there. And my summary comments are that, you know, it is... TFF is moving forward splendidly. The opportunities are greater than ever. Everything that you have seen and believe in TFF is there, but I think even bigger than perhaps you may realize. We'll come out of this period of market darkness, and we're doing everything we can to be sure that the company will return great value to you in the shortest term possible. I want to thank my team, thank all the investors and your support. As you know, I make myself quite available to you, so if you have any questions at any time, you can contact me or Corey, and we'll answer your questions. Hope you all stay well, and thank you. Enjoy your evening.
spk01: And thank you, sir. The conference has now concluded. Thank you for attending today's presentation. You may now
Disclaimer