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Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Theratechnologies Third Quarter Fiscal Year 2021 Earnings Call. [Operator Instructions]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.
Thank you, Catherine, and welcome, everyone. Mr. Paul Lévesque, 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.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. In preparing these forward-looking statements, several assumptions were made by Theratechnologies, and there are risks that actual results 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. Theratechnologies refers current and potential investors to the forward-looking information section of its management's discussion and analysis issued this morning, available at sedar.com and on EDGAR at sec.gov. Forward-looking statements represent their technologies 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 statements, whether as a result of new information, future events or otherwise.I would now like to turn the call over to Paul. Paul?
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 stands in our effort to build upon the clear and strong operational results that have been achieved in fiscal 2021 thus far. At the beginning of the fiscal year, we set forth the logical strategic plan to lead the company toward inevitable growth and transformation and our commercial and investigational pipelines. As we move well into the back half of our fiscal year, our efforts are beginning to show fruit.We are continuing to further unlock the unrealized value, held in our commercial business through product life cycle management and innovation, while at the same time, building on the vital quality of proof-of-concept work needed to advance the promising therapeutic potential of our investigational oncology portfolio and Phase III development programs in NASH. Through this end, we are extremely excited about the progress made in the Phase I 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 2021, recognizing TH1902 and our SORT1+ Technology as a broadly applicable cancer agnostic treatment for patients with sortilin-expressing solid tumors. This morning, we provided an interim safety update noting that to date, we have dosed several patients in Part A of the study, with some participants receiving more docetaxel when conjugated to TH1902 than the indicated dose of docetaxel alone. Additionally, patients that have received up to 300-milligram per square meter of TH1902, which is equivalent to approximately 1.5x the indicated therapeutic dose of docetaxel, have not experienced any Grade 2 adverse events. The last patient that was dosed in the trial received 420 milligrams per square meter of TH1902 or approximately 2x the indicated dose of docetaxel.And at that level, the patient experience 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. As a reminder, Part A dose escalation study of the Phase I trial is primarily met to establish a maximum 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.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 helps ] in the cancer cells. TH1902 is targeting the SORT1 receptor, which is a very prominent receptor in many solid tumors.In terms of next steps for this program, we will plan to provide another update of the Phase I 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 2022.As one of the only biotech companies currently targeting SORT1 receptor in the treatment cancer, we are fully committed to this journey of pioneering a novel and potentially transformational treatment to a broad class of hard-to-treat cancers. Therefore, we're taking the same approach to garnering scientific support for this program as we did for our Phase III program in NASH. Aligned with this strategy follows the appointment of Dr. Mace Rothenberg as a scientific adviser for our SORT1+ technology oncology platform. We are very excited to have Mace as part of our team as he brings more than 30 years' 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've had the opportunity to work with him.During his time at Pfizer, as CMO, the company initiated completed and obtained emergency use authorization for its COVID-19 vaccine and obtained regulatory approvals for 11 new cancer medicines. Mace will no doubt be an important adviser to Theratechnologies as we advance our oncology platform through development and towards approval.We are also looking at additional opportunities to expand the regulatory and commercial scale for TH1902 in other geographies. Currently, we are exploring potential cooperation and alliances with China-based organizations to evaluate TH1902 in patients in greater China that are suffering from sortilin-expressing cancers.By gaining the support and scientific expertise of a 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.As we think about the future objectives of our SORT1+ Technology platform, there are a number of additional value-driving opportunities that we will work toward, including evaluating different dosing schedules, such as weekly or intermittently that may potentially increase the therapeutic window in terms of safety and efficacy; exploring the possibility of conjugating with different anticancer agent, including cytotoxins, like SN-38 and irinotecan and TKI in evaluating synergistic partnerships; and finally, exploring the rational combination with other cancer treatments, especially immunotherapies. But for the near term, we remain focused and committed to completing our first 1 -- or Phase I trial as quickly as possible.Turning to our Phase III program in NASH. The company continues to evaluate our options to most effectively execute the Phase III clinical 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 the potential partnership with this program, and we also explore other opportunities to initiate the trial in a timely manner.In support of these initiatives, we recently hosted a virtual NASH webinar featuring Dr. Rohit Loomba, Stephen Harrison, and Steve Grinspoon, who are key opinion leaders in hepatology, endocrinology and NASH. The event provided a deep dive into our innovative approach to treating NASH and tesamorelin 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.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 COVID pandemic was an unfortunate and unforeseeable event, which has no doubt materially impacted most of the health care industry, we want to know that in many ways, the pandemic's transformational pressures have only accelerated the health care industry's need to move toward digital health, which has been an ongoing presence in health care for the past decade. Engagement between HCPs and the patient care journey have increasingly shifted toward new behavioral patterns that are largely driven by a need for better technology and immediate access to HCPs.When I came on board at Theratechnologies, we made the 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 digitalized training and product education tools and have ultimately created a solid go-to-market model. As a result, sales increased nearly 30% in the third quarter over 2021 over last year, supported by a 65% increase in EGRIFTA SV sales. The improvement in EGRIFTA SV sales is a direct result of a return to some face-to-face meetings and greater and more efficient digital campaigning at [indiscernible] education, which also led to a 40% increase in new prescribers during the quarter. Based 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.In terms of market expansion in HIV beyond our existing markets, we have also made progress toward securing pricing and reimbursement agreements for Trogarzo in several countries outside of the U.S., including Italy, most recently, which is an integral part of our Trogarzo growth strategy. Specific to our progress in the Italian market, Theratechnologies and the Italian Medicines Agency recently reached a reimbursement agreement for Trogarzo, and we expect that this medicine will become commercially available to all eligible patients in Italy by the end of fiscal year 2021.Our life cycle management strategy for 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 patient. 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 of administration. This more convenient IV push mode administration requires only 2 quick infusions per month, offering patients a rapid infusion type, thereby potentially increasing patient compliance and allowing patients to benefit from long-acting protection against HIV-1 when Trogarzo is administered with other antiretrovirals.Based on the results of the IV push study, we plan to file an sBLA with the FDA during this quarter. In addition, patients screening to evaluate an intramuscular or IM method 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 studies named the Trogarzo PROMISE trial that will evaluate the real-world, long-term efficacy and safety of Trogarzo in combination with other antiretrovirals. This study is expected to enroll patients in the EU during this quarter, while a similar study we'll be initiating in the U.S. in the first quarter of [ 2022 ], enhancing our portfolio of real-world evidence with Trogarzo. We'll provide our field force with additional and important market data to support their discussions with patients and HCPs.Based on today's business update, it is clear to see that we are proceeding as planned and executing against the polls 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 I Part A study in TH1902 have demonstrated and look forward to both interim and full data readouts in this program over the next several quarters.We're also encouraged by the current commercial landscape that has begun to show signs of recovery and expanding market penetration as we continue to unlock the intrinsic value held 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 III program in NASH and advance this exciting program towards a potential approval.With that, I will turn the call over to Philippe, who will provide the Q3 financial summary. Philippe?
Thank you, Paul, and good morning, everyone.Theratechnologies has posted strong overall results for the third quarter of 2021, registering 27% growth over the same period in 2020. We recorded sales of $17.9 million for the quarter and $51.1 million for the first 9 months of the year. Sales of EGRIFTA performed well as the effects of the pandemic are showing signs of wearing off. We recorded sales of $11.2 million for EGRIFTA in the third quarter, up 64% from the same period last year, a period which had been negatively affected by the transition to EGRIFTA SV from the original version.Sales of Trogarzo for the quarter were down 7.8% compared to last year and came in at $6.6 million. As mentioned in the past, Trogarzo's new prescriptions have been more impacted by COVID as patients have been more reluctant to visit health care 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 are seeing since the start of the fourth quarter.Cost of goods sold in the third quarter of 2021 amounted to $4.3 million, down slightly from $4.6 million for the same quarter last year. This is due in large part to a higher proportion of sales of EGRIFTA, which carries a lower cost of goods sold and a lower cost of goods sold for Trogarzo, which decreased from 62% to 52% during the third quarter of last year.As we advance the development of our SORT1+ technology in oncology with the initiation of our Phase I trial for TH1902 and we continue to get ready for the launch of our Phase III trial for tesamorelin in NASH, R&D expenses are increasing. In Q3 2021, they stood at $8.3 million compared to $4.2 million for the same quarter last year. R&D expenses also included expenses related to the medical science liaison team and medical education activities in the U.S. and in Europe as well as the development of the F8 formulation of EGRIFTA and the multi-dose pen injector.Selling expenses in the third quarter of 2021 were up 9%, standing at $7.7 million compared to $7 million 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. G&A expenses grew to $3.6 million in the third quarter of 2021 compared to $2.7 million for the same quarter last year. The increase in G&A expenses was mainly associated with an overall increase in business activities, senior hires to support our sales activities in the U.S. and head office functions as well as increased activity in Europe.In Q3 2021, net finance costs amounted to $2.3 million compared to $799,000 in Q3 of 2020. Finance costs mostly represented interest on the senior convertible notes issued in June 2018 and a foreign currency loss as opposed to foreign currency gain in the third quarter of 2020. For the third quarter of 2021, we recorded a net loss of $9.5 million or $0.10 per share compared to a net loss of $6.8 million or $0.09 per share for the same period last year.During our third quarter of 2021, our operations, including working capital variations, used $3.1 million, which includes a positive impact of $1.4 million from changes in operating assets and liabilities. Our financial position remains strong with $51.6 million in cash and bonds at the end of the third quarter.I will now turn the call back to Paul for some closing remarks.
Thank you, Philippe. From a commercial perspective, we are very pleased with the improvements made since the beginning of 2021, and we are optimistic for future growth based on our third quarter results.In terms of our operational and pipeline performance, we've had 3 quarters of solid progress that have been transformational for the organization. Looking ahead, we remain committed to building out our clinical and commercial assets and achieving a valuation for the company that is much better aligned with the opportunities ahead of us. I look forward to continuing to report on the positive progress that the team of Theratechnologies has worked so hard to achieve.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 call line. Operator?
[Operator Instructions] And our first question over the phone comes from Andre Uddin with Research Capital.
Paul, Philippe and Christian, I 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, is the U.S. Trogarzo competitor, is that Rukobia in terms of the competitor there?
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. 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, it won't -- 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.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 trial that they had that was significantly large and ended up creating a bolus of patients for them at the beginning. But I remain optimistic that Steve is going to help us expand and extend that segments of multidrug 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?
The only thing I'd add, Paul, is that we do see a shift in the MDR market to long-acting. And as you 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 multidrug in the HRD space is changing, and there are competitors that are coming out that are going to impact that.
Thank you for your question.
Okay. And then just in terms of the Canadian market, do you have any foreseeable plan 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.
Thank you. Philippe, I'll turn to you for the BD in a moment. When it comes to the Canadian market, EGRIFTA is approved here, but it's only its previous formulation. And since you know that we have DSP, but we are committed to shifting and transitioning to the F8, a more convenient mode of administration next year, that's probably where we're going to kind of revamp our plan for Canada. We're not turning our 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 involved in our programs. But we're well grounded in Canada, and we'll continue to look for opportunities. Philippe, business development.
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 adviser as 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 1 or 2. And so we've initiated a process, a formal process. There's quite a bit of interest in China for the oncology platform. Again, very early to report 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 -- 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. And I think we're starting to have pretty good name here. So we're having -- we're seeing some very interesting science come our way.
We have a question from Edward Nash with Canaccord Genuity.
I 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&D. There were several things in there, obviously, sortilin 1 and then the pen injector. I look at things like the pen injector is kind of a one-off, one-in-dime-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 run rate we should expect over the next quarter and then the rest of next year? Or should we expect it to be variable?
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 we'll start in the EU and in North America as well. So I guess that level is sustainable even though there are certain projects that will be falling off activity, and activity 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 into Phase I, we'll be enrolling 3 by 3. And then when the expansion trial comes in, it's 40 patients. So next year, there should be a ramp-up on the oncology program.
Okay. That's helpful. 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 the feed push from physicians to better understand how they would incorporate Trogarzo for those multidrug-resistant patients?
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. It comes with the approval we got to get going with a post-marketing surveillance trial. 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?
Yes. This is a very, very good tool of our clinical team. And as Paul mentioned, for Europe, it was requested by EMA. And in the U.S., we decided to implement the study with a slight change. We will do retrospective data entry in the patients that have been treated so far. Then this is a good tool to interact with our physicians. And hopefully, in the near future, maybe in a year from now, we'll be able to start reporting good long-term safety and efficacy data that it's a good tool to interact with the physician and potentially good publication on our own products.
[Operator Instructions] We have a question from Endri Leno with National Bank.
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 is it safe to assume that most of the decline you saw this quarter is because of the competition?
Well, I think -- thank you for the question. I think we said in previous quarters, and we haven't changed our mind that there was a multifactor playing out. Trogarzo is an IV infusion. Patients were asked to stay home. They needed to go to the clinic, to the hospital at a time where physicians were telling them to stay at home. So that impacted, obviously, us capturing new patients, putting new patients on therapies. And at the same time, Rukobia came out in a pill 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.I think that now we see the situation changing a bit. 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 multidrug-resistant segment is opening up, so that we can both of us benefit from doctors being less lenient when it comes down to the viral load untreated and that they go about treating it. John, do you want to add anything?
I think that's it, Paul. I mean COVID certainly had a major effect on any IV drug. There was many instances in other disease states like oncology, where there was a shift to oral 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.
Okay. Great. So the other question on Trogarzo is, if you can talk a little bit about the cadence of new reimbursement plans in Europe. I mean -- because there are several other countries I think that you've talked before to potentially target to France, Spain, U.K. Any color you can give me there in terms of timelines?
He's wondering about the reimbursement and the successive launches in Europe, what we're seeing.
Okay. Well, I mean, as you know, we've got some cohorts in some countries now, France, in particular, where we are under ATU. So temporary authorization, 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 countries 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 being big advocate for us to get reimbursement. 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 in early and mid-2022. So we're gearing up now to really capitalize on this situation. And again, I think that in Europe, we are ahead of Rukobia in many countries. And the market dynamics are different. I think the KOLs in Europe are playing a much bigger role as opposed to the HIV 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.
Okay. Great. My next question is on TH1902. I was wondering if you guys can comment a bit in terms of if the -- if you saw the Grade 4 SAE on the 420-milligram dose, would that suggest that that could be the MTD? Or is it more work that you need to do there? Or do you need to see another SAE in that dose group to make that call?
Christian?
Yes, absolutely. Well, this is -- we're not there yet with the MTD. The way it works is even like what we need to see is what we call a dose-limiting toxicity. And what we have seen so far is a neutropenia without fever. Therefore, it's not yet the DLT. Then once we reach like Grade 2 adverse events, we need to enroll more patients at that dose level. And once we have a total of 3 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. Then what I can say about this Phase I trial is at the moment, it is really what we have -- what we were expecting from the animal data that we had then.We are now at those levels that are in the range of about 2x docetaxel. We have dosed patients at 300 without Grade 2 adverse event, which means that we can administer up to 1.5x the dose of docetaxel when conjugated with TH1902 without having any adverse events. Then we're getting close to the MTD. That's the dose that we're expecting. Based on the animal model, we need a few 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 the MTD towards hopefully the end of this year. And after that, we'll be able to initiate our basket trial beginning of 2022.
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 1.5x the dose of docetaxel that we're able to carry without significant side effects. So we haven't reached the maximum targeted dose, Christian was clear on this. And it's 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 I trial. But for now, what we see is very encouraging. I'm going to say that again, because we can, it seems, give 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 into trial.
Okay. Great. One more question there. I don't know if you have the data on it yet or even want to disclose at this point. But was there any difference in the sortilin expression between the patients that you've treated in terms of how they respond to the different doses?
At the moment, we're, as I mentioned before, in discussion with FDA. We are not selecting patients based on the expression of the sortilin receptor, and this is normal. It was requested by the FDA because we need to assess eventually what will be the level of the sortilin receptor, like the association between the receptor and the efficacy.On the other hand, we are collecting the information. We will do the staining with the immunohistochemistry test, and we will have the information. Then at the end of the 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 selected based on the expression of the receptor. And that's what we will 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.
Thank you, Christian. This is a key, key, key fact to understand. The patients in the dose escalation are all comers. They are not selected based on their level of SORT1 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?
And there are no other questions on the phone line.
Okay. So there are quite a few questions on the webcast and most of them are related to the timing of the Phase I 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 in the trial? Any reason why the trial seems to be a little behind schedule?
Well, yes, this is the first time that we're seeing what we call in this case is the Grade 4 neutropenia, but it's a Grade 2 adverse event. And it's the first time that we see the Grade 2 adverse events since the initiation of the trial. And as you remember, we started with 30-milligram per day per meter square. And this is what we -- like we're able to increase -- double the dose, 1 additional patient, only 1 patient per dose as per the protocol. Once we reach the 200-milligram, it was the Fibonacci escalation dose theme that is 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.But as I said before, we're very happy that we reached the dose of 420-milligram per meter square. It shows that we can give more docetaxel with 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 drugs that enter the cancer cell than the noncancer cells, that if we give 1.5x the dose of docetaxel and there's more drug entering the cancer cell, hopefully, that will have an impact on the efficacy.In terms of the timing, we're right on. The cycles are given every 3 weeks. But to recruit the following patient, we need to have all of the safety data. We need to look at data carefully, and it will take probably 4 to 5 weeks between each patients. And I must say that at the moment, we're right on target and probably even higher to some extent with the 420-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 notice.
Okay. Paul, you can close.
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 order 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. We're not behind. We're 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 committed to the NASH trial. And 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 they would be a good fit from a 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 shareholders to finance this trial.We are sitting on a Phase III ready-to-go program in NASH. It's one of the highest unmet medical need area, and I don't see why we 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.
This concludes today's conference call. Thank you for participating. You may now disconnect.