TFF Pharmaceuticals, Inc. (NASDAQ:TFFP ) Q3 2022 Earnings Conference Call November 14, 2022 5:00 PM ET
Corey Davis - LifeSci Advisors Ceftazidime Pentahydrate
Glenn Mattes - President, CEO & Director
Dale Christensen - Head, Clinical Development
Kirk Coleman - CFO, Treasurer & Secretary
Robert Williams - Technology Inventor & Special Advisor
Jonathan Aschoff - ROTH Capital Partners
Vernon Bernardino - H.C. Wainwright & Co.
Michael Okunewitch - Maxim Group
Greetings, and welcome to the TFF Pharmaceuticals, Inc. Third Quarter 2022 Earnings Conference Call. [Operator Instructions].
It is now my pleasure to introduce Corey Davis. Thank you, and you may proceed.
Thank you, operator. Hello, everyone, and welcome to TFF Pharmaceuticals' Third Quarter Financial and Business Results Conference Call. With me on the line today is Glenn Mattes, 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, TFS'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 release and 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 Factors 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 Mattes. Go ahead, Glenn.
Good afternoon. Thank you for joining us today to review TFF third quarter operations and recent highlights. During this call, I'll provide an update on our overall progress and then ask our Chief Financial Officer, Kirk Coleman, to review our third quarter financials. Kirk and I will provide the formal commentary and then open up the call for questions. 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 our internal portfolio 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 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 voriconazole Powder or TFF VORI. Dr. Dale Christensen, the Head of our Preclinical and Clinical Development Group, is with me today and will now discuss the outcome of TFF voriconazole in compassionate use patients. Dale?
Back in September, we announced the successful treatment of a lung transplant patient with TFF VORI. Dr. Brad Gartner, an infectious disease physician with the Albert Hospital in Melbourne, Australia, presented this case so 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 work on sale 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 TFF VORI and has remained on therapy at 80 milligrams twice daily for the past 6 months. After receiving TFF VORI, the patient's lung function stabilized and they 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 voriconazole without having to lower the dose of histocrolemous 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 VORI under the same compassionate use program. In this particular case, the patient who had received a lung transplant approximately 20 years ago had a history of skin cancers and multiple long infections. During the prior treatment for the functions 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 2 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 pulmonary Aspergillus infection, the experience declining lung function. Because of the accumulated toxicities from prior azole antifungal therapy and the pre-existing skin cancers, oral voriconazole or other azole antifungals were no longer tolerable for this patient. After administration of TFF VORI, 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 TFF VORI.
This is important clinically due to the well-known severe drug-drug interactions between tacrolimus and oral voriconazole and reiterates the treatment of hypothesis that we can deliver inhaled vori with efficacy and reduced drug-drug interactions.
Safety and efficacy continue to look quite promising in this case as the patient has been on TFF VORI therapy for 6 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 TFF VORI, which we expect to further demonstrate in our Phase II study.
The treatment outcomes from these 2 compassionate use patients clearly have significant positive implications for the therapeutic and commercial potential of our unique and proprietary technology. Positive outcomes from these 2 patients who have very different cases would suggest that TFF VORI may have broad utility across pulmonary fungal infections.
To further underscore the significant market potential of TFF VORI, 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 infections with high fatality rates, lack of assistive vaccines and treatments and growing resistance to antifungal drugs.
More specifically, as it relates to TFF, invasive aspergillosis and candidiasis were lifted as critical pathogens and these 2 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 TFF VORI 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.
Thank you, Dale. Now I'll discuss the timing of the TFF 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 time lines 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 time lines 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.
With regulatory processes 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 trial fully enrolled. Specifically, TFF is committed to hiring a Chief Medical Officer. I will be working closely with Dr. Harlan Weisman on this search.
Based on these efforts, we are guiding that we anticipate reporting preliminary patient data in the Phase II study of TFF VORI 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 continues to grow. Last quarter, we noted the progress being made with vaccines. Dr. Bill Williams and his colleague from the University of Texas and Austin published an 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 Lung 360 Meeting, highlighting thin film freezing applications across several commercial and development stage monoclonal antibodies, including anti-FRSV2 antibodies and anti-PD-1 antibodies, each of which represents multibillion-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 life cycle management.
With respect to the niclosamide 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. We 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 infection.
Last week, we announced the joint effort between Aptar and TFF to test drug formulations using our thin film freezing technology, with Aptar's proprietary Unidose nasal power 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 includes potentially better efficacy as the nasal passage way is the likely first point of entry for respiratory pathogen. 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 TFF Pharmaceuticals 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 parameter, we next do in vivo testing. And many of these partnerships were 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 asked us to actually produce test patches that can be used in preclinical testing. TFF measures progress by how many of our partnerships are maturing through these different steps. Ultimately, we then entered the term sheet discussions with the partner.
Another update on the TFF cannabinoid opportunity. We continue to get positive feedback about our product from an increasing number of consumers. Based on the feedback, we are working to put together a national consortium of company 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 TFF and health cannabinoid formulations are very well received in our test markets. And there's a clear market opportunity provide an alternative vaping of CBD. We are encouraged by the outcome of the collaboration with Catalent. Catalent has been referring their clients to TFF, increasing the number of our overall partnerships. The government arena, the DoD or Department of Defense program is moving ahead well, and we continue the evaluation of TFF formulated countermeasures. Thus far, the results have been positive and our work with the U.S. Army under the 2 [indiscernible] 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 Weisman's lab, has demonstrated the advantages of the thin film freezing technology with a myriad of different large and small molecules an 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. Kirk?
Thanks, Glenn. For the 3 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 3 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 a net loss for the 3 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 3 months ended September 30, 2022, were 25,451,691 compared with 25,371,781 for the same period in 2021. As of September 30, 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.
Thank you, Kirk. The compassionate use data from our TFF VORI 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 this 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 infection.
Investors should also bear in mind that data from the TFF VORI 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 team 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?
[Operator Instructions]. The first question comes from Jonathan Aschoff from ROTH Capital.
I got like three questions here. Given the compassionate use patient results, does that allow for using inhaled voriconazole in a prophylactic setting? And what long-term benefits do you think this would confer to those patients?
Jonathan, this is Glenn. Thanks for the question. Dale, could you answer that, please?
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 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 tacrolimus levels that is typically subject to severe drug-drug interaction with voriconazole. 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 death 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.
My next question is, Glenn, in your statements, you mentioned publication by Dr. Williams. My question is regarding the paper by Dow at all on the effects of air micro bubbles by ice crystals during freezing that leads to freeze induced denaturing of proteins. What's the significance of that paper to you guys?
Thanks again, Jonathan. Bill, could you answer that, please?
Yes. Thank you, Glenn, and thanks, Jonathan, 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 sheer that's imported from the thin film freezing process, protected that protein and protected it from denaturation. So this is the significance to the TFF business. Thank you for the question. .
Jonathan, if I can just add one, many of the papers that Bill has just published lately, I just want to point this out, are coming from the partners materials. Now we have to redact specifically which partner and specifically our compound, but it's significant to note that these results are coming from the partnered programs. And I think that shows progress in the work we're doing with the partners. Thank you.
Okay. Lastly, you guys commented on the new Aptar relationship in that nasal device for administering dry powder nasally. Why is that noteworthy for you?
Yes. So if you go back a couple of months, maybe 3 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 Aptar 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 the thin film freezing in inhalation through intranasal administration. .
The next question comes from Vernon Bernardino from H.C. Wainwright.
Just wanted to follow up on the compassionate use. How predictive do you think the two compassion use patients you disclose data for of the larger population for the very product that you're exploring in Phase II?
Thanks for the question, Vernon. Dale, can I ask you to answer that question, please?
Yes. 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 6 weeks of treatment, the patient has returned a negative culture from bronchoscopy. And so that is highly indicative of success. And the patient 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 it just 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. .
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?
Yes. Thanks again, Vernon. So I will 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 at 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. .
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?
Yes, Dale, let me turn that over to you, and I'll probably listen to your answer and make a comment as well. .
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. We are working on that actively. .
And what, if any, is the progress with the DARPA contracts?
Dale is one of the PIs on that program. So Dale, I guess, it's most appropriate for you to answer that as well.
Yes. Thank you. So the DARPA contract that was awarded originally back in 2021, early in that year, there was an initial Phase I period of 2 years and then a second Phase II portion that is years 3, 4 and 5. We are rapidly coming up on that. The way the program worked is that DARPA awarded 2 contracts with a planned-down selection, so that only 1 group would get the Phase II portion. Right now, I think there's a high likelihood that the year 2 will go to our program. And 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 II. But it will be in early 2023 that we'll know that. .
Okay, early 2023. And I apologize if I missed this. Glenn, you wanted to say something?
Yes. 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 that technology performs very well.
Okay. I apologize for hogging up the time. But sorry also if I missed this, can you please elaborate on the type of data that you plan on revealing for both the TAC and VORI Phase II trials in 2023 and approximately how many patients in each trial?
Yes, Vernon. So as we said, we're going to announce preliminary data. These are open-label trials. And as we have accumulated enough of these patient data, as we said in the first quarter, 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 VORI and the guidance, second quarter for tacrolimus.
And a follow-up, how large historically have these such trials been?
Dale, can you probably answer some historical question. I think Dale will know it.
Yes. So historically, a Phase III trial in IPA for approval, if you go back to the most recent drug, isavuconazole, that was approved based on a 500-patient study, and that's the Phase III aspect. And so the Phase II that we're running is designed to gain data to allow us to fully figure out exactly how much power we're going to need to get to the noninferiority margin that would be and negotiate that with the FDA. So Phase III trials for registration are approximately 500 patients.
But Dale, since in this case, this is a 505(b) Type 2 type filing. We would expect that would be lower, right?
We may have to have a similar number of patients, but we only have to have a single Phase III study, whereas new entities do not require that.
Sure. Looking forward to that start. Thanks for taking my question and congrats again on all the exciting progress.
The next question comes from Michael Okunewitch from Maxim Group.
So obviously, there have been a lot of challenges across biotech with trial delays relating to the supply chain and staffing issues within health care. 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 vori?
That's a fair question, Michael. Yes, again, 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, and 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, 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 what we're doing to fix it. And 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 in 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 drug of voriconazole to the sites, has taken a lot longer. So the fix is in, and we've been implementing the fixes all along and hope that we would not have to take the slight delays really come down to how the TFF team. Dale is working directly to over companies 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 wherever we can, we've been putting -- Dale is extremely experienced in doing these types of trials along with this talented team to help to overcome it.
So albeit, we have a delay, and it's not one that wanted. It's a slight delay. And that's why right now, we think, based upon what we're doing, where we're at with the individual sites, we feel confident in the guidance that we give.
All right. And then I'd also like to follow up and see if you can give an update on the partnering activity for tac and vori. I know you discussed this a bit 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 progressing these? And do you have any thoughts on your intent to prioritize near-term nondilutive funding versus longer-term royalties?
So we've been -- the partners are looking at the compounds because 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 know exactly how many bases at 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 specifically any one type of transaction over another. We definitely want -- it's going to be a cash-driven deal. And how we reach total value and net present values, we're actually anxious to see exactly what the structure of those offers will be.
All right. And then just one last one for me, and I'll hop back in the queue, more of a housekeeping question. I just like to see if you gave an update on your ATM and how much you have on that?
Sure. Kirk, could you answer that question?
Absolutely, yes. Based upon the 10-Q that we just filed, we have approximately $34 million still remaining on the ATM.
There are no further questions.
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 who will listen to it later on the webcast, and I wish you all 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.
Ertugliflozin Powder 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.