THTX Q3 2021 Earnings Call
Operator: 00:05 Good morning ladies and gentlemen and thank you for standing by. Welcome to the Theratechnologies Third Quarter Fiscal Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. Following the presentation we will conduct a question-and-answer session. Instructions will be provided at that time for you to queue up for questions. [Operator Instructions] 00:43 I would now like to remind everyone that this conference call is being recorded today, Wednesday, October 13, 2021 at 8:30 A.M. Eastern Time. I will now turn the call over to Theratechnologies Head of Investor Relations, Leah Gibson. Ms. Gibson, please go ahead.
Leah Gibson: 01:03 Thank you, Katherine and welcome everyone. Mr. Paul Levesque, President and Chief Executive Officer of Theratechnologies; and Mr. Philippe Dubuc, Senior Vice President and Chief Financial Officer, will be the speakers on today's call. A Q&A session will follow their prepared remarks. 01:21 Before we begin, I would like to remind everyone that Theratechnologies remarks today contain forward-looking statements about its current and future plans, expectations, and intentions, results, levels of activity, performance, goals or achievements, or other future events and developments. 01:39 In preparing these forward-looking statements, several assumptions were made by Theratechnologies and there are risks that results actually obtained by the company will differ materially from those statements. As a result, the company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. 02:00 Theratechnologies refers current and potential investors to the Forward-Looking Information section of its Management's Discussion and Analysis, issued this morning, available at www.sedar.com and on EDGAR at sec.gov. Forward-looking statements represent Theratechnologies expectations as of October 13, 2021. Except for that which is required by Securities Laws, Theratechnologies does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. I would now like to turn the call over to Paul. Paul?
Paul Levesque: 02:44 Thank you, Leah. Good morning everyone, and thank you for being with us today. I'm very pleased to provide an update on where Theratechnologies ends in our effort to build upon the clear and strong operational results that have been achieved in fiscal twenty twenty one thus far. 03:02 At the beginning of the fiscal year, we set forth the logical strategic plan to lead the company towards inevitable growth and transformation and our commercial investigational pipeline. 03:14 As we move well into the back half of our fiscal year our efforts are beginning to yield fruit. We're continuing to further unlock the unrealized value held in our commercial business through product lifecycle management and innovation, while at the same time building on the vital body of proof-of-concept work needed to advance the promising therapeutic potential of our investigational conjugate portfolio and Phase 3 development programs in NASH. 03:44 To this end, we are extremely excited about the progress made in the Phase 1 study evaluating our novel peptide-drug conjugate TH1902 for the treatment of sortilin-positive cancers. As you recall, we received fast track designation from the FDA in January twenty twenty one, recognizing TH1902 and our SORT1+ Technology as a broadly applicable cancer agnostic treatment for patient with sortilin-expressing solid tumors. 04:17 This morning, we provided an interim safety update noting that date, we have dosed several patients in Part A of this study, with some participants receiving more docetaxel, when conjugated to TH1902, than the indicated dose of docetaxel alone. 04:34 Additionally, patients that received up to three hundred square meters of TH1902, which is equivalent to approximately one point five times therapeutic dose of docetaxel have not experienced any grade 2 adverse events. 04:51 The last patient that was dosed in the trial received 420mg/m2 of TH1902 or approximately two times the indicated dose of docetaxel and at that level the patient experienced grade 4 neutropenia. We are now awaiting all safety information to come in, so we may assess the next dosing level and pursue the study as per the approved protocol design. 05:17 As a reminder, Part A dose escalation study of the Phase 1 trial is primarily met to establish the maximize tolerated dose. While we have not yet identified what the maximum tolerated dose will be, what we have observed thus far is very encouraging. Because it seems that TH1902 is better tolerated than docetaxel alone. 05:40 Furthermore, in our preclinical work, we have demonstrated that TH1902 can potentially penetrate the cancer cell far more effectively than docetaxel alone and increase the concentration of docetaxel specifically where it counts in the cancer cells. TH1902 is targeting the SORT 1 receptor, which is a very prominent receptor in many solid tumors. 06:05 In terms of next steps, for this program, we will plan to provide another update of the Phase 1 Part A study when we have reached the maximum tolerated dose of TH1902 at which time we may have early signs of efficacy data to report. We continue to expect initiating the Part B basket trial in the U.S. and Europe in early twenty twenty two. 06:29 As one of the only biotech companies currently targeting SORT 1 receptor into treatment of cancer, we are fully committed to this journey [indiscernible] a novel and potentially transformational treatment to a broad class of hard-to-treat cancers. Therefore, we're taking the same approach to [gathering] [ph] scientific support for this program as we did for our Phase 3 program in NASH. 06:55 Aligned with this strategy, follows the appointment of Dr. Mace Rothenberg as a scientific advisory for our SORT 1+ technology oncology platform. We are very excited to have Mace as part of our team as he brings more than thirty year’s experience across government, academia and the biopharmaceutical industry, most recently serving as Chief Medical Officer at Pfizer before his retirement earlier this year, where I had the opportunity to work with him. 07:25 During his time at Pfizer as CMO, the company initiated completed and obtain emergency use of authorization for its COVID-nineteen vaccine and obtained regulatory approval for its eleven new cancer medicines. Mace will no doubt be an important advisor to Theratechnologies as we advance our oncology platform through development and toward approval. 07:50 We are also looking at additional opportunities and regulatory commercial installed for TH1902 in other geographies. Currently, we are exploring potential cooperating and alliances with China based organization to evaluate TH1902 in patients in Greater China that are suffering from sortilin-expressing cancers. 08:11 By gaining the support, and scientific expertise of the locally based organization to help us develop TH1902 we are better positioning ourselves to bring this potential treatment to patients faster and more effectively, which is at the foundation of our oncology strategy. 08:29 As we think about the future objectives of our SORT 1+ technology platform, there are number of additional value driving our opportunities that we will work towards, including evaluating different dosing schedules such as weekly or internally that may potentially increase the therapeutic window in terms of safety and efficacy, exploring the possibility of conjugating with different anti-cancer agent, including cytotoxic like SN-38 and [indiscernible] evaluating synergistic partnerships and finally exploring the rational combination with other cancer treatments, especially in immunotherapies. 09:12 But for the near term, we remain focused and committed to completing our first one or Phase 1 trial quickly as possible. 09:23 Turning to Phase 3 program in NASH, continues to evaluate our options to most effectively execute the Phase 3 trial of tesamorelin for the treatment of NASH, which includes seeking a potential partner. As we announced in our last earnings call, an external U.S. based biopharma advisory firm was retained to assist in identifying a potential partnership for this program. And we also explored other ore opportunities to initiate the trial in a timely manner. 09:54 In support of these initiatives, we recently hosted a virtual NASH webinar featuring Doctor Rohit Loomba, Stephen Harrison, and Steve Grinspoon were key opinion leaders in hepatology, endocrinology, and NASH. The event provided a deep dive into our innovative approach to treating NASH [indiscernible] and also demonstrated the distinct support this program has from these leading disease and industry experts. We look forward to updating you on the advancement of our NASH program soon. 10:30 Moving on to the commercial side, we're happy to report on the uptick in activity and demand for EGRIFTA SV for the treatment of lipodystrophy. While the pandemic was unfortunate and an unforeseeable event, which has no doubt materially impacted most of the healthcare industry. 10:48 We want to know that in many ways the pandemic times pressures have only accelerated the healthcare industry's need to move toward digital health, which has been an ongoing presence in healthcare for the past decade. 11:01 Engagement between HCPs and the patient care journey have increasingly shifted towards new behavioral patterns that are largely driven by a need for better technology and immediate access to ACPs. 11:15 When I came on board at Theratechnologies, we made a conscious decision to move the company towards this path and coincidentally at the start of the pandemic. Since then, we have challenged the fundamentals of our business, developing a mature business acumen, which includes a more focused field force. And digitalize training and product education tools and have ultimately created a solid go to market model. 11:43 As a result, sales increased nearly thirty percent in the third quarter over twenty twenty one over last year supported by sixty five increase in EGRIFTA SV sales. The improvement in EGRIFTA SV sales is a direct result of a returning to some face-to-face meetings and greater and more efficient digital campaigning and [indiscernible] patient, which also led to a forty percent increase in new prescribers during the quarter. 12:09 Based you on this momentum, we believe we have begun to revert back to a pre-COVID sales environment, but with a much better level of cross functional team execution, creating a springboard for growth for our approved medicines. 12:26 In terms of market expansion in HIV beyond on our existing markets, we have also made progress towards securing pricing and reimbursement agreements with regards in several countries outsized of the U.S., including Italy most recently, which is an integral part of our growth strategy. 12:45 Specific to our progress in the Italian market, our technologies and Italian medicines agency recently reached a reimbursement agreement with Trogarzo, and we expect that this medicine will become commercially available to all eligible patients in Italy by the end of fiscal year twenty twenty one. 13:05 Our life cycle management strategy with Trogarzo is also progressing nicely. Most recently, we announced results for the TMB-302 study evaluating an IV Push mode of administration of Trogarzo in HIV-1 patients. This internal study achieved consistent and statistically significant results demonstrating that there was no difference in pharmacokinetics between the IV Push and the current IV Infusion mode administration. 13:37 The mode of convenient IV Push mode administration [indiscernible] two good infusions from offering patients or rapid infusion time, thereby potentially increasing patient applicant, and allowing patients to benefit from long-acting protection against HIV-1 when Trogarzo is administered with other antiretrovirals. 13:59 Based on results of the IV Push study we plan to buy an sBLA with the FDA during this quarter. In addition, patient screening to muscular or IM method of administration of Trogarzo is also planned to begin this quarter. Further supporting our growth strategy for Trogarzo is our plan to initiate a post-authorization study named the Trogarzo PROMISE trial that will evaluate the real-world long-term efficacy and safety with Trogarzo and combination with other antiretrovirals. 14:34 This study is expected to enroll patients in the EU during this quarter, while similar study will be initiating in the U.S. in the first quarter of twenty twenty. Enhancing a portfolio of real-world evidence for Trogarzo will provide our deal force us with additional and important market data to support your discussions with patients and HCPs. 14:58 Based on today's business update, it is clear to see that we are proceeding as planned and executing against the goals that we have rolled out at the beginning of this year. In oncology, we are extremely pleased and encouraged by the early indication that the Phase 1 Part A study in TH1902 have demonstrated and look forward to both interim and full data results in this program over the next several quarters. 15:25 We're also encouraged by the current commercial landscape that has begun to show signs of recovery in expanding market penetration as we continue to unlock the intrinsic value of health in our EGRIFTA SV and Trogarzo medicines for HIV. And we continue to work tirelessly to evaluate opportunities to most effectively execute our ready to proceed Phase 3 program in NASH and advance this exciting program toward a potential approval. 15:56 With that, I will turn the call over to Philippe, who will provide Q3 financial summary. Philippe?
Philippe Dubuc: 16:02 Thank Paul and good morning everyone. Theratechnologies posted strong overall results for the third quarter of twenty twenty one, registering twenty seven percent growth over the same period in twenty twenty. We recorded sales of seventeen point nine million dollars for the quarter and fifty one point one million dollars the first nine months of the year. Sales of EGRIFTA performed well as the effects of the pandemic are showing signs of wearing [halves] [ph]. 16:30 We recorded sales of eleven point two million dollars for EGRIFTA in the third quarter, up sixty four percent from the same period last year, a period which had been negatively affected by the transition to EGRIFTA from the original version. 16:47 Sales of Trogarzo for the quarter were down seven point eight percent compared to last year and came in six point six million dollars. As mentioned in the past, Trogarzo with new prescriptions had been more impacted by COVID as patients have been more reluctant to visit healthcare facilities. Sales were also impacted by the entry of a new competitor in the multidrug resistant market. We are encouraged by the new prescription numbers we're seeing since the start of the fourth quarter. 17:20 Costs goods sold in the third quarter of twenty twenty one amounted to four point three million dollars down slightly from four point six million dollars for the same quarter last year. This is due in large part to a higher proportion of sales, EGRIFTA, which carries a lower cost of goods sold and a lower cost of goods sold for Trogarzo, which decreased from sixty two percent to fifty two percent during the third quarter of last year. 17:50 As we advance the development of our SORT 1+ technology in oncology, with the initiation of our Phase 1 trial for TH1902 and we continue to get ready for the launch of our Phase 3 trial for tesamorelin in NASH, R&D expenses are increasing. In Q3 twenty twenty one, they stood at eight point three million dollars compared to four point two million dollars for the same quarter last year. 18:17 R and D expenses also included expenses related to the medical [indiscernible] and medical education activities in the U.S. and in Europe, as well as the development of the F8 Formulation of EGRIFTA and a multi-dose pen injector. 18:35 Selling expenses in the third quarter of twenty twenty one were up nine percent standing at seven point seven million, compared to seven million dollars for the same period last year. This is mainly associated with increased activities in Europe as we gear up for a number of country launches in the upcoming quarters. 18:57 G and A expenses grew to three point six million dollars in the third quarter of twenty twenty one, compared to two point seven million dollars for the same quarter last year. The increase in G and A expenses was mainly associated with an overall increase in business activities, senior hires that support our sales activities in the U.S., and head office functions, as well as increased activity in Europe. 19:23 In Q3 twenty twenty one, net finance costs amounted to two point three million dollars compared to seven hundred and ninety nine thousand dollars in Q3 of twenty twenty. Finance costs mostly represented interest on the senior convertible notes issued in June twenty eighteen and a foreign currency loss as opposed to a foreign currency gain in the third quarter of twenty twenty. 19:50 For the third quarter of twenty twenty one, we’ve recorded a net loss of nine point five million dollars or zero point one zero dollars per share compared to a net loss of six point eight million or zero point zero nine per share for the same period last year. During our third quarter of twenty twenty one, our operations, including working capital variations used three point one million dollars which includes a positive impact of one point four million from changes in operating assets and liabilities. Our financial position remains strong with fifty one point six million dollars in cash and bonds at the end of the third quarter. 20:28 I will now turn the call back to Paul for some closing remarks.
Paul Levesque: 20:33 Thank you, Philippe. From a commercial perspective, we are very pleased with the improvements made since the beginning of twenty twenty one, and we are optimistic for future growth based on our third quarter results. In terms of our operational pipeline performance, we've had three quarters of solid progress that have been transformational for the organization. 20:56 Looking ahead, we remain committed to building out with our clinical and commercial assets and achieving evaluation for the company that is much better aligned with the opportunities ahead of us. 21:08 I look forward to continuing to report on the positive progress that the team at Theratechnologies has worked so hard to achieve. 21:16 With that, we will now open the call up to questions from the audience. As a reminder, questions can be submitted in written form via the webcast platform. We will also take analysts question via the conference line. Operator?
Operator: 0:21:36 Thank you. [Operator Instructions] And our first question over the phone comes from Andre Uddin with Research Capital. Your line is open.
Andre Uddin: 21:54 Good morning, Paul, Philippe, and Christian. Just had a couple of questions, in terms of Trogarzo, I was just hoping you could elaborate a little bit more on the pricing of it in the EU? And also, with the U.S. Trogarzo competitors at Rukobia, in terms of the competitor there? Thanks.
Paul Levesque: 22:17 Thank you, Andre for your questions. Well, we have achieved a very solid price in Italy in our negotiation. The price is not public at this time. I don't believe it is. However, we're very pleased with this because it's going to be an anchor point in Europe. 22:37 So this is a good start for us. We're happy and actually the negotiation in Italy was pretty stunning because despite the COVID environment over there, only God knows how much they were affected by that. We ended up ahead of schedule and in negotiating pricing and reimbursement. And as I said, at a pretty solid anchor point that will be very important for the rest of Europe in our negotiation. 23:04 When it comes down to Rukobia, Rukobia is a competitor to Trogarzo as you said. It has made some significant inroads in the U.S. based on their field force presence and also the trials that they had that was significantly large and ended up reading a bonus of patients for them at the beginning. 23:23 But I remain optimistic that these is going to help us expand and expand that segments of multi-drug resistance, and I think that we're trying to find a way to continue to be relevant and I'm very optimistic about the future. John do you want to add a few things?
John Leasure: 23:41 I’ll only [indiscernible] is that we do see a shift in the MBR market to long acting and as know, Trogarzo is the first long-acting agent and so as more long acting agents come out, I think that we're going to see more interest and more movement in that direction. But the landscape in the multi drug space is changing and there are competitors that are coming out that impact that.
Paul Levesque: 24:07 Thank you for your question.
Andre Uddin: 24:09 Okay. Thank you. And then just in terms of the Canadian market do you have any foreseeable plans there for partnerships or launches if you could elaborate a little bit on that. And then if you could just also give us a bit of a business development update as well in terms of out-licensing and in-licensing, that'd be great. Thanks.
Paul Levesque: 24:32 Thank you. Philippe I'll turn to you for the BD in a moment. When it comes to Canadian market, EGRIFTA is approved here, but it's only its previous formulation, and since you know that we have the SV, but we are committed to shifting and transitioning to the F8 more convenient mode of administration next year. That's probably where we're going to kind of revamp our plan for Canada. 25:02 We're not turning over back to Canada, but this is not our priority at the moment. And when it comes down to the clinical development, we’ll see at what stage we want to have or not some Canadian centers involve in our programs. But we're well rounded in Canada and we'll continue to look for opportunities. Philippe business development?
Philippe Dubuc: 25:23 Yes. Well as Paul mentioned on the NASH program, the outreach is continuing and we have had some discussions with potential partners, but there's no real update at this point. On the oncology, we've had some, we hired the advisors well for Greater China. We have received some inbound interest from Chinese companies and we decided to go out much broader than just dealing with one or two. And so, we've initiated a process, a formal process. There's quite a bit of interest in China for the oncology platform. 26:01 Again, very early to report any anything substantial, but we’re frankly pretty encouraged with the interest that we've seen. On the in-licensing side, it's a little less active although we have been approached with some very interesting earlier stage projects. So, we're not quite ready to discuss that. But there is, you know, one of the plans that we have is to act as a catalyst for research that is being done here in Quebec in addition to in-licensing other technologies. 26:38 And I think we're starting to have a pretty good name here. So, we're having – we’re seeing some very interesting [signs coming our way] [ph].
Andre Uddin: 26:48 Great. Thank you.
Operator: 26:52 Thank you. We have a question from Edward Nash with Canaccord Genuity. Your line is open.
Edward Nash: 26:58 Hi, good morning guys. Thanks for taking my question. Wanted to just ask, I guess my first question is just one about model housekeeping. Philippe, I know you mentioned with regards to the increase in R and D, there were several things in there obviously sortilin one and then the pen injector, I look at things like the pen injector as kind of a one-off, one in done type thing. But obviously, as you guys are now starting to ramp up with the oncology side of things, the number we saw in the third quarter is that a pretty reasonable runway we should expect over the next quarter and the rest of next year or should we expect it to be variable?
Philippe Dubuc: 27:41 Yes. I think it's a good indicator. As you said, some of these projects will go away, but we have more like Paul mentioned the PROMISE trial, which will start in EU and in North America as well. So, I guess that level is sustainable even though there are some projects that will be falling off activity and should be ramping up in the oncology program as well because as you know, we've been enrolling patients one by one. And as we move deeper in the Phase 1 we be rolling three by three and when the expansion trial comes in, it's forty patients so next year, there should be to ramp up on the oncology program.
Edward Nash: 28:27 Okay, That's helpful. Thank you. And then just with regards to the PROMISE studies, which I think make a lot of sense, I guess my question is, was this more driven internally by you guys to try to help further educate physicians or were you actually getting to feed, push from physicians to better understand how they would incorporate regards for those multi drug resistant patients?
Paul Levesque: 28:55 Thank you Edward. And I’ll ask Christian to provide additional color, but you should know that first of all, this is an obligation we have in Europe that comes with the approval we got to get going with a post the marketing struggling trial. 29:08 But in my experience from a strategic point of view, this is great stuff because you actually give a chance to a lot of KOL to develop hands on experience. And I think this is going to be a strategic activity for us in the upcoming years with Trogarzo and our commitment is big. Christian do you want to add anything?
Christian Marsolais: 29:29 Yes, this is a very, very good tool for our clinical team. And as Paul mentioned for Europe, it was requested by EMA. And in the U.S. we decided to implement this study with a slight change. We will deliver with [indiscernible] treated the patients that I've been treated so far, and this is a good tool to interact with our physicians. And hopefully in the near future, maybe in the year from now, we'll be able to start reporting good long-term safety and efficacy data. It’s a good tool to interact with the physician and potentially good publication on our products.
Edward Nash: 30:02 Got it. Thanks so much Appreciate it.
Paul Levesque: 30:06 Thank you, Edward.
Operator: 30:10 [Operator Instructions] We have a question from Endri Leno with National Bank. Your line is open.
Endri Leno: 30:22 Hey, good morning. Thanks for taking my questions. I'll start with Trogarzo, I was wondering if you guys could talk a little bit on the sales on the breakdown of that decline? I mean because, we saw there was COVID-related drops even last year like so, is it safe to assume most of the decline you sold this quarter is because of the competition?
Paul Levesque: 30:46 Well, I think – thank you for the question. I think we said in previous quarters and we haven't changed our mind that that was a multi-factor playing out. Trogarzo is an IV Infusion. Patients were asked to stay at home. They needed to go to the clinic to the hospital at a time where physicians were telling them to stay at home. 31:07 So that impacted obviously, us capturing new patients putting new patients on therapy. And at the same time, Rukobia came out in the [pill] [ph] mode and although we absolutely believe that BID, is more pills and patients are facing pill fatigue, so it's directionally incorrect. But for a short period of time, it was kind of favorable to them and unfavorable to us. 31:33 I think that now we see a situation changing. And as I said before, what is absolutely important to me is that we team up in a way to make sure that the segment the multi-drug resistant segment is opening up so that we can both us benefit from doctors being less lenient when it comes down to the viral road on untreated and that they go about treating it. John, do you want to add anything?
John Leasure: 32:02 I think that's it Paul. I mean, COVID certainly had a major effect on any IV drug. There was many in other disease days like oncology where there was a shift to world agents. And so, I think we were impacted by that certainly. But as Paul said, we have had a new competitor launch and that has also had an impact.
Endri Leno: 32:24 Okay, great. Thanks for the color. So, the other question on Trogarzo, so if you can talk a little bit about the cadence of new reimbursement plans in Europe. I mean, there are several other countries, I think that you've talked before to potentially target as the fan paying, UK, any color you can give in there in terms of timelines?
Philippe Dubuc: 32:49 He’s wondering about the reimbursement and successive launches in Europe what we're seeing.
Paul Levesque: 32:54 Okay. Well, I mean as you know, we've some cohorts in some countries now, at France in particular where we are under ATU. So, a temporary authorization. If the patients are reimbursed at full price, and meanwhile, we're doing the pricing and negotiation with the government. It's one of our major country over there. But as I said before in the midst of the pandemic, we were able to accelerate negotiation in Italy. And Italy came out as showing leadership. We have many KOLs on the ground that are coming forward and ended up big advocate for us to get reimbursement. 33:36 So that will be published in the next couple of weeks and we believe that we're going to have by the end of this year reimbursement, and therefore we'll start our activities on the ground. Now most of the other countries will unfold and early mid twenty twenty two, so we’re gearing up now to really capitalize on the situation. And again, I think that in Europe, we are ahead of Rukobia in many countries. And the market dynamics are different. 34:06 I think the KOL in Europe are playing a much bigger role as opposed to [indiscernible] providers in the U.S. So, the go to market model may be different and may not require that we deploy a huge amount of resources to actually get going with our commercial model.
Endri Leno: 34:28 Great. Thank you for the color. My next question is on TH1902. I was wondering guys comment a bit, if you saw the grade 4 SAE on the four twenty milligram dose, would that suggest that that that could be the MTD or is it more work that you need to do there? Or do you need to see another in that dose group to make that call?
Paul Levesque: 34:53 Christian?
Christian Marsolais: 34:54 Yes, absolutely, well, this is – we're not there yet with the MTD. The way it works as even like what we need, you see is what we call a dose [indiscernible] toxicity. And what we have seen so far is a neutropenia without fever, therefore it is not yet a DLT and once we reach and like a great to adverse events, we need to enroll more patient at that dose level. And once we have to treat a total of three patients treated at that dose level, we decide if we can continue to increase or if we remain at the same dose or if we have to lower the dose. 35:29 Then what I can say about this Phase 1 trial at the moment, if this really what we have what we were expecting from the animal data that we had. And we are now at those levels that are in the range of about 2x docetaxel. We have dose patients at three hundred with that rate to adverse event, which means that we can administer up to one point five times the dose of docetaxel when conjugated with on TH1902, without having any adverse events. 35:59 Then we're getting close to the MTD. That's the dose that we're expecting based on the animal model, we need two more patients to be able to define our MTD, but it doesn't mean that in terms of efficacy, that it wouldn’t show efficacy at lower doses. Then we're on track. We continue MTD. We should probably reach MTD towards, hopefully the end of this year and after that we’ll be able to initial our basket trial beginning of twenty twenty two.
Paul Levesque: 36:28 Thank you, Christian. It's got to be clear to everyone this morning that all of this is directionally correct. And quite frankly, we're very proud of where we are because it's a very least one point five times. The docetaxel that we're able to carry without significant side effects. So, we haven't reached the maximum [indiscernible]. Christian was clear on this and is very important that we carry on the dose escalation to find out what that is, which is going to inform the Part B of that Phase 1 trial. But for now, what we see is very encouraging. I'm going to that again because we can't. It seems, if you get more docetaxel better tolerated and it is directionally very exciting, and hopefully that is going to translate to the efficacy we saw in the animal model once we get further down the trial.
Endri Leno: 37:22 Okay. Great. One more question, I don't know if you have the data on it yet or even, I want to disclose at this point, but was there any difference in the sortilin-expressing between the patients that you've treated in terms of how they respond to the different doses?
Christian Marsolais: 37:40 At the moment, as I mentioned before in discussion with the FDA, we are not selecting patient based on the expression of the sortilin and this is normal. It was requested by the FDA because we need to assess eventually what will be the level of sourcing receptor like the association between the receptor and the efficacy. 38:02 On the other hand, we are collecting the information. We will do the [indiscernible] and we will have the inform then. At the end of MTD, if there are some patients that are responding or stabilizing, we'll be able to see if there's a correlation with the expression of the receptor. But those patients are not to select based on the expression of the receptor. 38:23 And that's what we'll do as well in the basket trial. It's very important to be able to determine what level of expression of the receptor is needed to show efficacy.
Paul Levesque: 38:33 Thank Christian. This is a key effect to understand the patient and the dose escalation are all comers. You are not selected based on their level of sortilin-expression. That's very important that people understand that. We take all-comers, people that are at the end of the line when it comes down to their own treatment and therefore they are the patients that we're treating with TH1902. Any additional questions?
Endri Leno: 39:02 No, that's it. That’s great color actually. Thank you very much.
Operator: 39:07 Thank you. And there are no other questions on the phone line.
Paul Levesque: 39:12 Okay. So, there are there quite a few questions on the webcast and most of them are related to the timing of the Phase 1 trial. So, I think they have been addressed, but there's one here that I will ask Christian is, was the one grade 4 SAE, the only one seen so far at the trial, any reason why the trial seems to be a little behind schedule?
Christian Marsolais: 39:36 Well, yeah, this is the first time that we're seeing what we call in this case it’s a grade 4 neutropenia, but it's a grade 2 adverse event and it’s the first time that we see a grade 2 adverse events since the initiation of the trial. And as you remember, we started with thirty million per day, square and this is what we like we're able to increase double the dose, one additional patient only one patient per dose as per the protocol, once we reached the two hundred milligram escalation dose that it's no longer doubling the dose, but it is done because we know that we're getting closer to some toxicity and we don't want to double the dose anymore. 40:17 But as I said before, we're very happy that we reached the dose of 420mg/m2, it shows that we can get more dose effects on TH1902 than docetaxel alone. And if you remember from the animal data, we always mentioned that in the presence of the sortilin receptor, it looks like there are more drive that it turned against cell and the non-cancer cell. And if we give one point five times to those of docetaxel and therefore more to entry to cancer cell, hopefully that will have an impact on the efficacy. 40:49 In terms of the timing, we're right up. The cycles are given every three weeks, but to recruit the following patient, we need to have all of the safety data. We need to [indiscernible] data carefully. It would take probably four to five weeks between each patient and I must say that at the moment, we're right on the target and probably even higher to some extent to four twenty milligram and now we will decide once we have all of the information and safety, what will be the next dose for the following patients and if we need to enroll more patients at the following doses. Paul, you can conclude.
Paul Levesque: 41:29 Okay. Well, thank you very much for your questions. And the enthusiasm this morning. I just want to wrap up in saying that first of all, we had a solid quarter from a revenue point of view. This is really, really exciting to us. Coming out of the COVID being able to deploy resources in an effective manner. We are very enthusiastic about the progress of TH1902. This is very exciting. We carry on. 41:54 We're not behind. We are where we thought we would be. And this early report tells us that it seems like our TH1902 is better tolerated than docetaxel alone. This is directionally correct, very excited. And we're still coming committed to the NASH trial. We've said many, many times that we're looking for a partner. We are in discussion. We want to see if there are some partners available where it would be a good fit from the capability and resourcing point of view and we're committed to the trial. So, if we don't find a partner, we’ll find alternate way, responsible way for our shoulders to finance this trial. 42:34 We are sitting on the Phase 3 ready to go program in NASH. It's one of the highest unmet medical need area, and I don't see one would sit on it, so we're committed to finding a way to put that in the clinic. So, again thank you very much for attending today and looking forward to the next update at the next quarterly report. Thank you again.
Operator: 42:59 This concludes today's conference call. Thank you for participating. You may now disconnect.