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spk01: And welcome to the TFF Pharmaceuticals Inc. Third Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Corey Davis. Thank you, and you may proceed.
spk09: Thank you, operator.
spk03: Hello, everyone, and welcome to TFF Pharmaceutical's third 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 head of preclinical and clinical development, Dr. Bill Williams of the University of Texas at Austin, and Chris Cano, TFF's Chief Operating Officer. A press release announcing our third quarter results is available on the recently updated TFF Pharmaceuticals website, and we hope you all have an opportunity to visit the site soon. 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 2021 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. Go ahead, Glenn.
spk07: Good afternoon, and thank you for joining us today to review TFS third quarter operations and recent highlights. During this call, I'll provide an update on our overall progress, and then I ask our Chief Financial Officer, Kirk Coleman, to review our third quarter financials. Kirk and I will provide the formal commentary, then open up the call for questions to the entire team. Please note that we are joined by Dr. Bill Williams, Dr. Dale Christensen, and Chris Cano, who are also available to help answer questions. On our last quarter's conference call, we spent a considerable amount of time highlighting the unique attributes of thin-film freezing and why we believe this technology can be broadly applied to our internal portfolio and partnership opportunities. This quarter, I would like to discuss how we're actively applying thin-film freezing to real-world clinical practice that, in my view, will create significant value for patients, our internal pipeline, CFS partner programs, and for our shareholders. First, Let's focus on the positive clinical proof of concept data recently generated from our Compassionate Use Program with inhaled boriconazole powder for TFF4E. Dr. Jeff Christensen, head of our preclinical and clinical development group, is with me today and will now discuss the outcomes of TFF4E and Compassionate Use patients. Dale?
spk04: Back in September, we announced the successful treatment of a lung transplant patient with TFF4E. Dr. Brad Gardner, an infectious disease physician with the Albert Hospital in Melbourne, Australia, presented this case study at the 15th International Congress on Lung Transplantation. This case marked the first time we demonstrated in patients the significant therapeutic value of delivering life-saving medicine using our proprietary thin-film freezing technology. In this case, the patient was unable to take oral Voriconazole to help fight the serious lung infection he developed in the years after transplant due to post-transplant immunosuppression medications that are required to prevent rejection of the transplanted lung. Due to prior toxicity when he previously received oral Voriconazole and due to prior skin cancers that can be exacerbated by oral Voriconazole, the patient had a poor prognosis with very few available treatment options. In February 2022, the patient began treatment with TFF4E and has remained on therapy at 80 milligrams twice daily for the past six months. After receiving TFF4E, the patient's lung function stabilized and he did not require any further hospitalization. Due to the limited systemic absorption compared to the oral administration route, the patient was also able to tolerate inhaled chloroconazole without having to lower the dose of histicrolimus immunosuppressant, which can have a severe drug-drug interaction with oral voriconazole. Following this news, earlier this month, we announced that a second lung transplant patient was successfully treated with TFF-4E under the same compassionate use program. In this particular case, the patient who had received the lung transplant approximately 20 years ago had a history of skin cancers and multiple fungal infections. During the prior treatment for the fungal infections with oral voriconazole and posaconazole, the patient experienced several side effects associated with this therapy, including hair loss, fatigue, and an increased QTC interval that required discontinuation of two of their cardiovascular medications. After discontinuing a recent course of posaconazole, the patient experienced increased coughing, shortness of breath, and did not respond to oral antibiotics. The patient was subsequently diagnosed with a pulmonary aspergillus infection and experienced declining lung function. Because of the accumulated toxicities from prior azole antifungal therapy and the preexisting skin cancers, oral voriconazole or other azole antifungals were no longer tolerable for this patient. After administration of TFF4E, the patient's lung function is stabilized. and there was no need to modify the patient's current dose of tacrolimus, an outcome also consistent with the results seen in the first patient receiving TFF4E. This is important clinically due to the well-known severe drug-drug interactions between tacrolimus and oral voriconazole and reiterates the treatment hypothesis that we can deliver inhaled 4E with efficacy and reduced drug-drug interactions. Safety and efficacy continue to look quite promising in this case, as the patient has been on TFF4E therapy for six weeks and has returned negative cultures for Aspergillus in recent specimens obtained from bronchoscopic evaluation. These results support the potential safety and efficacy advantages of TFF4E, which we expect to further demonstrate in our Phase 2 study. The treatment outcomes from these two compassionate use patients clearly have significant positive implications for the therapeutic and commercial potential of our unique and proprietary technology. Positive outcomes from these two patients who have very different cases would suggest that TFF4E may have broad utility across pulmonary fungal infections. To further underscore the significant market potential of TFF4E, we point to the first ever report from the World Health Organization on fungal priority pathogens, which identified 19 fungi, which they identified as significant public health threats due to their ability to cause severe invasive infection with high fatality rates, lack of effective vaccines and treatments, and growing resistance to antifungal drugs. More specifically, as relates to TFF, invasive aspergillosis and candidiasis were listed as critical pathogens. And these two invasive fungal infections account for 90% of fungal infections among immunocompromised patients. While the mortality rate for invasive candidiasis is not as high as invasive pulmonary aspergillosis, which is the target of our TFF-Vory product, both have unacceptably high mortality. The report noted the need for effective new treatments. in the management of immunocompromised patients, which would comprise patients with infectious disease such as flu, cystic fibrosis, cancer, HIV AIDS, lung disease, and transplant surgery, including solid organ transplant and stem cell transplant. These patients are highly susceptible to fungal and bacterial infections due to their immunocompromised condition. Now, I'd like to turn it back to Glenn.
spk07: Thank you, Dale. Now I'll discuss the timing of the TSF-VORI and TSF-TAC programs. Earlier in the month, we reported that several external factors impacted clinical trial operations and logistics for both Phase II studies, which led us to reassess timelines surrounding when we would be in a position to discuss preliminary data. These are challenges that many companies in drug development continue to face. I want to emphasize that we have been keenly aware of the mounting execution challenges. The team has been working diligently to overcome these issues so that we can meet the timelines described in our most recent guidance. Here are some examples. We continue to work closely with our CRO to ensure that our programs are staffed optimally. The CRO has been experiencing transition issues during a post-merger period. Our sites are also experiencing staffing issues. The TFF team is working directly with the site to provide support and help increase the focus on managing the patient recruitment process. Where the regulatory process has caused delay, we're also working locally to help expedite reviews and clear any paperwork hurdles. This is important as we are opening more sites to accelerate completion of the trial. Where needed, TFF will add people to get the trials fully enrolled. Specifically, TFF is committed to hiring a chief medical officer. I will be working closely with Dr. Harlan Weissman on this search. Based on these efforts, we are guiding that we anticipate reporting preliminary patient data in the Phase II study of TFF-BORI in the first quarter of 2023. And for TFF-TAC, we expect to announce preliminary patient data in the second quarter of 2023. As we accumulate data from our clinical programs, the applications of the thin-film freezing platform continue to grow. Last quarter, we noted the progress being made with vaccines, as Dr. Bill Williams and his colleagues from the University of Texas at Austin published important new research showing how thin-film freezing can be used to improve vaccine formulations by avoiding particle aggregation. This quarter, Dr. Williams and his colleagues presented additional new research at this year's AAPS Pharm360 meeting, highlighting thin-film freezing applications across several commercial and development-stage monoclonal antibodies, including anti-SRS-CoV-2 antibodies and anti-PD-1 antibodies, each of which represents multi-billion-dollar markets Based upon this growing body of research, we believe thin-film freezing can provide an ideal formulation solution for companies seeking to develop next-generation delivery modalities for these high-value commercial assets while also affording additional patient protection to help lifecycle management. With respect to the glycosamide inhaled powder program, we and our partner, Union Therapeutics, have not further progressed TFF niclosamide pending the party's further review of the Phase I results, animal data, and antiviral market opportunities. Remain confident in the data generated from our thin-film freezing niclosamide formulation and look forward to providing an update for this program after Union and TFF agree on how best to move forward with this program for the treatment of severe viral infections. Last week, we announced a joint effort between Aftar and TFF to test drug formulations using our thin-film freezing technology with Aftar's proprietary unit-dose nasal powder system. A growing body of scientific research suggests that developing a shelf-stable dry powder vaccine formulation delivered intranasally could dramatically change the existing vaccine landscape. Potential advantages of intranasal delivery over conventional subcutaneous or intramuscular-based delivery include potentially better efficacy as the nasal passageway is the likely first point of entry for respiratory pathogens. So direct treatment to these exposed tissues could help prevent the spread of infection, thereby improving overall prognosis. In the coming months, We expect the results from our testing will be published by Aptar Pharma, the University of Texas at Austin, and TSR Pharmaceutical released a publication describing the positive results of our internal feasibility work. Additional studies are ongoing, designed to demonstrate outcomes with specific product opportunities. On the business development front, we continue to make progress with our partners. We measure the progress of these partner programs by tracking where we stand on fulfilling the work defined in the material transfer agreement and statement of work. That progression begins with formulation development and feasibility, followed by in vitro testing. Once the partner agrees that we have met their stated parameters, we next do in vivo testing. In many of these partnerships, we're given multiple compounds to test. The partner ultimately decides which target or targets are desirable for additional work. Once successful, these formulations are put on stability. The length of stability is also determined by the partner. Finally, some partners ask us to actually produce test patches that can be used in preclinical testing. EFF measures progress by how many of our partnerships are maturing through these different steps. Ultimately, we then enter the term sheet discussions with the partner. and other updates on the TFS cannabinoid opportunity. We continue to get positive feedback about our product from an increasing number of consumers. Based on this feedback, we are working to put together a national consortium of companies who will invest in an impactful launch of the product. That work continues and we'll provide updates as those plans evolve. The key message is that the TFS inhaled cannabinoids formulations are very well received in our test markets. And there's a clear market opportunity to provide an alternative to vaping of CBD. We are encouraged by the outcome of the collaboration with Catalan. Catalan has been referring their clients to TFF, increasing the number of our overall partnerships. The government arena, the DARPA or Department of Defense program is moving ahead well, and we continue the evaluation of PFF-formulated countermeasures. Thus far, the results have been positive, and our work with the U.S. Army under the two craters have resulted in positive animal data, which will enable us to seek further government funding. Likewise, the data generated at the University of Georgia, Georgia Tech, Einstein College of Medicine, and the University of Pennsylvania, which is Dr. Drew Weissman's lab, have demonstrated the advantages of the thin-film freezing technology for the myriad of different large and small molecules at in vitro and in vivo stages of development. All of these partnerships continue to enhance the total portfolio of data for thin-film freezing. These data assist in expanding our partnership portfolio across the board. I'd like to now turn the call over to our Chief Financial Officer, Kirk Coleman, to review our third quarter financial results.
spk00: Thanks, Glenn. For the three months ended September 30, 2022, research and development expenses for the company were $4 million compared to $6.3 million for the same period in 2021. General and administrative expenses for the three months ended September 30, 2022, for the company were $3.3 million compared to $2.4 million for the same period in 2021. The company reported net loss for the three months ended September 30, 2022, of 7.3 million compared to a net loss of 8.7 million for the same period in 2021. Weighted average common shares outstanding basic and diluted for the three months ended September 30th, 2022 were 25,451,691 compared with 25,371,781 for the same period in 2021. As of September 30th, 2022, We had total assets of approximately 20.2 million and working capital of approximately 14.9 million. At the end of the third quarter, our liquidity included approximately 13.1 million of cash and cash equivalents. And with that, I'd like to turn the call back over to Glenn.
spk07: Thank you, Kirk. The compassionate use data from our TFF board program clearly highlights the opportunity that lies ahead for our technology. our company, and of course, our investors. When we think about positive data from this program, coupled with the recent WHO report on the critical need to address aspergillosis infections, a considerable market opportunity exists for developing an improved version of this life-saving antifungal treatment, a treatment that can not only address lung transplant recipients, but also the broader global population suffering from these dangerous infections. Investors should also bear in mind that data from the TFF Void Program represents only our first step along this value creation pathway as we continue to generate clinical data from our pipeline and partnered programs. We believe the value of our thin film freezing platform will only continue to grow. Through our external partnership activity, we have now reached a critical mass of internal and external programs that demonstrate the feasibility of thin-film freezing formulations across an incredibly diverse set of molecular structures and treatment modalities to support this growth. We will continue to make targeted and prudent investment decisions across our organization to maximize the opportunity of bringing this unique and potentially groundbreaking technology to as many drug development programs and partners as possible. Thanks to all the TFF teams for their hard work and positive outcomes. And thanks, as always, to all of our investors. And with that, I'll turn the call back to the operator and open it up to questions. Operator?
spk01: Thank you very much, sir. We will now be conducting a question and answer session. If you would like to ask a question, please press star and then one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary for you to pick up your handset before pressing the star keys. One moment please while we poll for questions. The first question comes from Jonathan Eshoff from Roth Capital. Please proceed with your question, Jonathan.
spk05: Thank you. Good evening, guys. I got like three questions here. Given the compassionate use patient results, does that allow for using inhaled Voriconazole in a prophylactic setting? And, you know, what long-term benefits do you think this would confer to those patients?
spk07: Hi, Jonathan. This is Glenn. Thanks for the question. Dale, could you answer that, please?
spk04: Yes, thanks, Glenn, and thanks, Jonathan, for the question. The data that we've gotten out of the compassionate use program really suggests that there is a great opportunity as prophylaxis. Voriconazole and other azoles are not favored for prophylaxis because of the severe drug-drug interactions. And so far, in both patients, we have seen absolutely no effect on Tercrolimus levels that is typically subject to a severe drug-drug interaction with Vorticonazole. And so this suggests that our route of administration will reduce drug-drug interactions and it also presents the opportunity to start these patients on prophylactic treatment right after they get their lung transplant, but also potentially in cancer patients that can also avoid getting them sick in the first place. One of the best ways to prevent deaths from infectious disease is to prevent them from getting the infection in the first place. So I think this really opens the door for prophylaxis in these patients.
spk05: Thanks, Dale. My next question is, Glenn, in your statement, you mentioned publications by Dr. Williams. My question is regarding the paper by Dow et al. on the effects of air microbubbles by ice crystals during freezing that leads to freeze-induced denaturing of proteins. What's the significance of that paper to you guys?
spk02: Thanks again, Jonathan.
spk07: Bill, could you answer that, please?
spk02: Yes, thank you, Glenn, and thanks, Johnson, for the question. So these scientific papers that come out of our group, they come out. We're addressing problems that we observe, and we are highly focused on differentiation of thin-film freezing from other technologies. And so this paper is critical to educating scientists across the pharma industry about all the applications of thin-film freezing. In this Dow paper, for the first time, we showed that conditions of the freezing process significantly affected protein integrity, particularly when that protein is surface active. And most proteins, from my experience, are surface active. And here we confirmed that the intermediate freezing rate of thin-film freezing and the lack of a significant shear that's imparted from the thin-film freezing process protected that protein and protected it from denaturation. So this is the significance to the TFF's business. Thank you for the question.
spk05: Thank you.
spk07: Charles, I'd just like to add, if I can just add one. Many of the papers that Bill has published lately, I just want to point this out, are coming from the partner's materials. Now we have to redact specifically which partner. and specifically what compound, but it's significant to note that these results are coming from the partner programs, and I think that shows progress in the work we're doing with the partners. Thank you.
spk05: Okay. Lastly, you guys commented on the new Aptar relationship and that nasal device for administering dry powder nasally. Why is that noteworthy for you?
spk07: Yeah, so if you go back a couple of months, maybe three months, there's been a lot of information and belief that ultimately the best way to deliver vaccines, and in this case it was really started by Dr. Fauci talking about the best way to deliver COVID vaccines is intranasally because of its exposure to the nasal mucosa. We believe that using thin-film freezing to create inhalable powders is really the best and really almost the only way to do that. And we think, certainly in the work that we're doing with Aptar, they recognize that as well. Aptar is the world's leading provider of such devices. And the work that we're doing together is systematically looking at the partnership of TFF and our technology along with the app to our devices to go across the board and look at different modalities and see how the device works and then to produce data. So in the coming weeks and months, you should see a succession of different releases of data that show how the device and the technology are working together. And we think that's a real springboard for a lot of opportunities of working together with Aptar and showing the real advantages of thin film freezing in inhalation through intranasal administration.
spk09: Thank you, guys. Thank you, Jonathan.
spk01: Thank you. The next question comes from Vernon Bernardino from HC Wainwright. Please proceed with your question, Vernon.
spk06: Hi, Glenn. Thanks for taking my question. Just wanted to follow up on the compassionate use. How predictive do you think the two compassionate use patients you disclosed data for are of the larger population for the very product that you're exploring in phase two?
spk07: Thanks for the question, Vernon. Diel, can I ask you to answer that question, please?
spk04: Yes, thanks, Glenn. This is a very good question. And ultimately I think it is, especially with the second patient, the first patient would not have qualified for our trial because of the organisms growing in that patient's lung not being aspergillus. But the second patient is an aspergillus patient and was seeing lung function decline, doing worse. And with six weeks of treatment, the patient has returned a negative culture from bronchoscopy. And so that is highly indicative of success. And so and the patient is also has been very easily administering the drug every day. And so the tolerability, the ease of use certainly has been proven out. So I think long term this bodes well for the inhaled voriconazole and this patient will be similar to the patients in the study. So I think the results so far lead me to believe that there will be similar results coming out of the Phase II study.
spk06: Very exciting. And then regarding the partnerships, what are potential partners looking for in terms of the outcomes and the scope of the trials before they would choose to sign a licensing deal? And how far into development would you be willing to take both programs if the deal terms that you're looking for don't materialize.
spk07: Yeah, thanks again, Vernon. So I'll comment that we have been successful in gaining a lot of interest in the programs. A number of these companies are already under CDA, and they're in the data rooms. As data is made available to the partners, that's what they're looking for, individual patient data. we're expecting them to finish their assessments and potentially make offers. And we believe that to the point that we receive those offers, we'll take a look and see if they're creating significant enough value for what we've invested and what we believe these assets are ultimately worth in the marketplace. In both cases, Vernon, the more we learn about the performance of voriconazole and tacrolimus. These are life-saving drugs, and we believe they have tremendous potential. And the company will take a look at the offers as they come in and assess our next steps, which may include taking them further into development. So it's really about value creation and meeting what we think should be significant expectations around what they're worth in a partnership or in the marketplace.
spk06: Great. That's very exciting. Glenn, you mentioned the who list. So switching on to that subject, does that open up any government grant opportunities?
spk07: Yeah, Dale, let me turn that over to you, and I'll probably listen to your answer and then make a comment as well.
spk04: Yes, so the information that we've gotten to date is that with the WHO list being released that there is likely to be an upcoming BARDA amendment to the broad agency announcement, the BAA. And we are certainly getting ready to apply for funding from that if in fact they are expanding. So we are working on that actively.
spk06: And what is, if any, is the progress with the DARPA contracts?
spk07: DL is one of the PIs on that program. So, DL, I guess it's most appropriate for you to answer that as well.
spk04: Yes. Thank you. So the DARPA contract that was awarded originally back in 2021, early in that year, there was an initial phase one period of two years and then a second phase two portion that is years three, four, and five. We are rapidly coming up on that. The way the program worked is that DARPA awarded two contracts and with a planned down selection and so that only one group would get the phase two portion. Right now, I think there's a high likelihood that the year two will go to our program and that we, you know, we've very successfully been formulating the countermeasures in the program. And so I'm very confident that our program will be the one that's selected to move forward and that we'll get phase two. But it'll be in early 2023 that we'll know that.
spk06: Okay, early 2023. Thank you. And I apologize if I missed this. Glenn, you wanted to say something?
spk07: Yeah, just to add on to what Dale was saying, this is also very exciting to see how well the technology is performing in these different types of programs. Again, this is intraocular. This is topical as well as inhaled. So Again, we continue to see wherever we use the technology, whether on our programs or partnerships, the technology performs very well.
spk06: Okay. I apologize for hogging up the time, but I'm sorry also if I missed this. Can you please elaborate on the type of data that you plan on reviewing for both the TEC and BORI Phase II trials in 2023 and approximately how many patients in each trial?
spk07: Yeah, Varda, so we, as we said, we're going to announce preliminary data. These are open-labeled trials. And as we have accumulated enough of these patient data, as we said in the first quarter, we should be able to, we will see current guidance of VORI patients and in the second quarter, TAC patients. We haven't disclosed publicly yet the number of patients in each trial. So I'll refrain from actually giving those numbers for how many patients we're targeting in each trial. But again, first quarter for Bavori and the guidance, second quarter for tacrolimus.
spk06: A follow-up on that. How large historically have such trials been?
spk07: Dale can probably answer some historical questions.
spk04: I think the other one. Yes. So historically, a phase three trial in IPA for approval If you go back to the most recent drug, that was approved based on a 500 patient study. And that's the phase three aspect. And so the phase two that we're running is designed to gain data to allow us to fully fully figure out exactly how much power we're going to need to get to the non-inferiority margin that would be and negotiate that with the FDA. So phase three trials for registration are approximately 500 patients.
spk07: But Dale, in this case, this is a 505B type two type filing. We would expect that would be lower, right?
spk04: We may have to have a similar number of patients, but we only have to have a single phase three study, whereas new age entities do not require that.
spk06: Right. Thank you. Terrific. Looking forward to that start. Thanks for taking my question, and congrats again on all the exciting progress. Thank you, Vernon. Thank you, Vernon.
spk01: Thank you. The next question comes from Michael Okunowicz from Maxim Group. Please proceed with your question, Michael.
spk08: Hey, guys. Thank you for taking my questions. So, obviously, there have been a lot of challenges across biotech with trial delays relating to the supply chain and staffing issues within healthcare. So, I'd like to see if you could give a bit more clarity on your confidence in being able to achieve the updated guidance for TAC and LORI.
spk07: That's a fair question, Michael. Notwithstanding what other companies have experienced, I can tell you what we've seen and have been seeing and working to improve. First and foremost, certainly doing work in patients who are involved with respiratory disease, we're going to a lot of the same investigators who are doing work in the COVID space. So staffing in particular, be it at the site, this has been a major issue. Sites have lost very talented people to doing more nationalized work on COVID trials. So I'll tell you what we're up against. I'll tell you what we're doing to fix it. I think I tried to address most of this in the text of the call. The regulatory authorities, specifically, Again, they're quite understaffed, and the time that it would take to get necessary approvals, be it at a country level or at a site level, has just been taking longer. People are just not there. We also uniquely experienced issues with our CRO. They had a business transition with a lot of turnover and staff that prolonged our ability to move the trials along as quickly as we would hope. And even down to global supply chain issues, for example, getting comparative drugs of Voriconazole to the sites has taken a lot longer. So the fixes, and we've been implementing the fixes all along and hoped that we would not have to take this slight delay, has really come down to how the TFF team is working directly to overcome these obstacles. Dale and his team have been on site in the countries. We've been working and trying to manage the CRO. I've been involved in talking directly to the CRO. We're going to open more sites in the countries that we're working, perhaps even more sites. We're helping the individual sites with recruitment. So where and wherever we can, we've been putting Dale, who's extremely experienced in doing these types of trials, along with his talented team, to help to overcome it. So albeit we have a delay and it's not unwanted, it's a slight delay, and that's why right now we think based upon what we're doing, where we're at at the individual sites, we feel confident and the guidance that we've given.
spk09: All right. Thank you for that.
spk08: And then I'd also like to follow up and see if you'd give an update on the partnering activity for TAC and VOR. I know you discussed this a bit earlier, but is there a certain data threshold that you think you need to meet to be confident that you'll be able to have those conversations? Or do you think you have enough data that you can actually start, you know, progressing these and Do you have any thoughts on your intent to prioritize near-term non-dilutive funding versus longer-term royalties?
spk07: So the partners that are looking at the compounds, they want to see data. It has not been quantified. I think as soon as they see directionally some positive data, they will act and hopefully we'll be able to see what types of offers they're willing to make at this point. So I don't think we have to, I don't know exactly how many patients, I think each partner has a potential different point of view and who wants to be a first mover. In terms of the deal structure, we will look at total value and we're not wedded to one, specifically any one type of of transaction over another. Um, we, uh, we definitely want it. This is going to be a cash driven deal. So, and how those, how we reach total value and net present values, uh, we're actually anxious. We anxious to see exactly what the structure of those offers will be.
spk08: All right. Thank you very much. And then just one last one for me and I'll hop back into the queue. More of a housekeeping question. I'd just like to see if, if you have an update on your ATM and how much you have on that.
spk07: Sure. Kirk, could you answer that question?
spk00: Absolutely, yes. Based upon the 10Q that we just filed, we have approximately $34 million still remaining on the ATM.
spk09: All right. Thank you for that. Okay. Thank you, Michael.
spk01: Thank you. There are no physical...
spk07: Okay, Claudia, thank you. Claudia, I'd like to thank you and all of the presenters. I also want to thank all of you that have been listening, either live or we'll listen to this later on the webcast. And I wish you all a very happy Thanksgiving and holiday season. We look forward to sharing with you our progress in the coming days, weeks, and months. Thank you very much.
spk01: Thank you very much, sir. This concludes today's teleconference. You may disconnect your lines at this time, and thank you very much for your participation.
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