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spk01: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to TheraTechnology's third quarter fiscal year 2022 earnings call. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session with analysts. Instructions will be provided at that time for you to queue up for questions. Following the analyst Q&A session, investors listening to submit a question may do so by clicking on the Ask a Question link on the webcast platform. If anyone has any difficulties hearing the conference, please press the star key followed by zero for operator assistance at this time. I would like to remind everyone that this conference call is being recorded today, October 13, 2022, at 8.30 a.m. Eastern Time. I will now turn the call over to Ms. Alif McDonald, Head of Investor Relations. Please go ahead, ma'am.
spk05: Thank you, Operator, and good morning, everyone. On the call today will be our President and Chief Executive Officer, Mr. Paul Levesque, and Chief Financial Officer, Mr. Philippe Dubuc. During the Q&A session, we will be joined by Dr. Christian Marcellet, Chief Medical Officer, and Mr. John Leisure, our Global Commercial Officer. Before we begin, I'd like to remind everyone that TheraTechnologies' remarks today contain forward-looking statements regarding its current and future plans, expectations, and intentions with respect to future events. Forward-looking statements are based on assumptions, and there are risks that results obtained by the company will differ materially from those assumptions. As such, the company cannot guarantee that any forward-looking statements will materialize, and you are cautioned not to place undue reliance on them. We refer current and potential investors to the forward-looking information section of our management discussion and analysis. issued this morning and available on CDAR at www.cdar.com and on EDGAR at www.sec.gov. Forward-looking statements represent TheraTechnologies' expectations as of October 13, 2022. With that, it is my pleasure to turn the conference over to TheraTechnologies President and CEO, Paul Levesque. Paul?
spk03: Thanks, Salif. Hello, everyone. Thank you for joining us today. Before we start our review of the current reporting period, I'm proud to say that thus far, BISchool 2022 has been an overwhelming success. Quantitatively, our performance to date stands as testimony to the company's hard work in transforming the business for both immediate and future growth. We have witnessed the organization come together as a team over the course of the last year, which is reflected in our numbers. We've put great consideration into our technology's forward operating plan, which has been designed to unlock value in the legacy business. This will be especially impactful now that we have built our own sales teams and have focused activities in the United States. This includes investing in areas such as our medical affairs programs to facilitate the diagnosis of patients with lyco dystrophy and the identification of patients with uncontrolled HIV viral load. We are also enhancing the patient experiences through improved methods of administration and new formulations. In speaking of the patient experience, we wanted to highlight the recent FDA approval of TRIGARZO for administration by 30-second IV push for heavily treated patients. This new method of administration reduces maintenance dose time from 15 minutes to 30 seconds. Not only the safety and PK profile of Trigarzo IV push similar to that of IV infusion, but the new method of administration is designed to make maintenance dosing easier on patients and healthcare providers. Thus, we firmly believe that we will be able to further expand Trigarzo into more clinics and increase patient adherence at the same time. Additionally, the new intramuscular study for Trigarzo is now fully enrolled, and the last patient visit is scheduled for next month. We believe that IAM could provide an even more convenient method of administration, including access to patient treatment outside of the clinic, such as in the pharmacy settings. We are delighted in the fact that we can demonstrate a strong commitment to fostering superior patient experiences. The simple fact of the matter is that the market is ramping up quickly towards non-oral regimens, so the approval of Trogarzo for IV push could not have come at a better time. Incidentally, SART Technologies announced data from two poster presentations at the AIDS 2022 conference showing the potential for improved treatment regimens. The first presentation demonstrated pharmacokinetic modeling data supporting proof of concept that additional methods of administration could be viable. This is a big endorsement for IM formulation administration for which the study will shortly be completed. Furthermore, the second presentations demonstrated how TROGARZO in combination with another fully active agent could lead to simpler dosing regimens in heavily treated experience populations. This abstract was selected as a top 300 abstract by the conference. Moving to IGRIFTA-SV now, which is a current formulation on the market. As previously announced, the FDA requested that the company carry out a human factor study with the ultimate goal of fine-tuning patient instruction for use. The study is ongoing and progressing well, and it is ultimately our hope that this will improve patient adherence to treatment. As the FDA has asked us to do a human factor study for IGRIFTA-SV, we have proactively decided to do one for DFA formulation as well. This study has been initiated and is running in near parallel to the SV study. Given the uncertainty regarding the supply of bacteriostatic water for injection, we have decided to take control of the situation and take matters into our own hands and have signed an agreement with a contract manufacturer to source the water ourselves. We believe this will firm up our timeline to launch the F8 formulation for lipodystrophy and ensure continuous supply of bacteriostatic water upon launch. In settling this go-forward strategy, we're currently on track to deliver the filing of this new F8 formulation in the fourth quarter of 2023 with a targeted launch date in the first quarter of 2024. Now, as a high-level overview of the reporting period, and with one more quarter to go, momentum in our business continues and the sales force that we have put in place is in full swing. As such, we are confident that we will deliver on revenue guidance of between $79 and $82 million while achieving new heights in the new fiscal year. To be more specific on product performance, we're happy to report that year-to-date U.S. revenue growth is a blend at 18% in line with our objectives. TRIGARZO revenues are up 17% year-to-date, while IGRIFTA SV sales are up 18%. This financial performance is being driven by our strategies to facilitate both diagnosis for lipodystrophy patients and patient identification for TRIGARZO. Philippe, as usual, will provide more insights into the reporting periods, consolidated numbers on today's calls, which does include Europe. As noted on the second quarter call, we separately announced the signing of a $100 million non-dilutive credit agreement with Marathon Asset Management, a major institutional healthcare investor. Not only was this a vote of confidence for Thera, the financing also lifts the financial burden of having to repay a convertible debenture due in June 23, which in turn further allows us to execute our commercial and pipeline development plans unencumbered. And while the new growth associated to our commercial activities is very exciting, the future of our technologies remain with the advancement of our powerful sort-one positive oncology platform. As such, we remain laser focused on recruiting patients and advancing the current basket trial. Earlier in the quarter, we provided an update on the dose escalation portion of TH-1902 phase one study and announced signs of efficacy that were observed in three heavily pretreated patients. The preclinical work that we're performing with our sort one positive technology is getting noticed by many in the industry and was featured in the recognized journal The data was published as part of the publication's special issue, Targeting Drug Resistance and Metastatic Pathways for Cancer Therapy. The publication highlighted the in vitro and in vivo efficacy of Th1902 in inhibiting ovarian and triple negative breast cancer stem-like cells. It also served to demonstrate potential mechanisms by which Th1902 can bypass underlying causes of resistance to docetaxel, contributing to treatment failure and disease recurrence. In prior studies, we have shown inhibition of vasculogenic mimicry in vitro, further adding to the body of evidence that SORT1 receptor in our peptide drug conjugate allows for enhanced benefits versus docetaxel alone. This is really the first evidence of Th19O2 targeting of human breast and ovarian cancer stem-like cells, both in vitro and in vivo preclinical models. Our excitement comes from the fact that the potential therapeutic benefits include sustained efficacy, as cancer stem cells can act as hidden cancer cell reservoirs, often associated with recurring cancers. Just yesterday, we announced that we have been selected to present new data showing high expression of SORT1 receptor in several cancer types, The data will be presented in a poster session at the 34th Joint Symposium of ENA, a highly recognized oncology conference that will take place at the end of the month in Barcelona, Spain. We continue to believe that our program's unique mechanism of action gives it an exceptional chance of succeeding where others have not been able to progress. On the TH1902 China Outlicensing and Partnership front, discussions are moving forward as enrollment of the basket trial continues. Finally, as per previous communications, the NASH program remains on pause until we have identified a partner with the capabilities and resources to carry this program forward. By making partnering a condition to advancing the program, we are acting responsibly vis-a-vis our investors as this is a costly endeavor. Recent positive news in the field of NASH has rejuvenated interest from many investors. As one of the only late-phase NASH companies with a mechanism of action that targets the dysregulation of fat accumulation in the ectopic compartments, including the liver, we feel more optimistic than ever in finding a partner and seeing this program move forward. I would like to now pass the call to Philip, our Chief Financial Officer. Thank you, Paul.
spk11: So I'll go over the financials before I turn the call over to the operator to start the Q&A. Consolidated revenue for the three-month period ended August 31, 2022 was $20.8 million compared to $17.9 million for the same year-ago period. representing an increase of 16.6% year-over-year. For the third quarter of fiscal 22, net sales of a GRIFTA SV reached 12.9 million compared to 11.2 million in Q3 of the prior year, representing an increase of close to 15% due to the combined effect of a higher number of units sold and a higher net selling price. In the third quarter of fiscal 22, Tregazo net sales amounted to $7.9 million compared to $6.6 million for the same quarter of 2021, representing an increase of approximately 20%. Higher sales of Tregazo were the result of a stronger performance in the United States, where we recorded 26% growth compared to the same quarter of last year. But these were also hampered by lower sales in Europe as a result of a weaker overall pricing environment. In the period, cost of goods sold was $5.3 million compared to $4.3 million for the same quarter last year. The increase in cost of goods sold was mainly due to higher sales of both EGRFTA, SV, and Tragarso, and were generally in line on a percentage basis with prior period's costs. R&D expenses amounted to $8.4 million in the three-month period ended August 31, 2022. generally in line with expenses of $8.3 million for the same year-ago period. R&D spending for 2022 relates mostly to our medical affairs programs and studies, our oncology phase one study, and other research, as well as spending on the intramuscular method of administration for Tragarzo, which should be completed in the fourth quarter of 2022. R&D expenses also include some severance costs related to our realignment in Europe. Selling expenses amounted to $8.4 million for the second quarter of 2022 compared to $7.7 million for the same three-month period last year. The increase in selling expenses also reflects one-time costs relating to the setting up of our internal field force in the U.S., as well as spending on new initiatives implemented in 2022 to increase awareness of our products in the North American market. The increase is also explained by severance costs related to our decision to exit the European market for Tragarso. G&A expenses in Q3 amounted to $4.2 million compared to $3.6 million reported in Q3 of last year. The increase in G&A expenses is largely due to increased overall business activities in 2022, as well as key hires in North America to support the implementation and management of our internal field force in the US. G&A expenses also included severance costs associated to our realignment in Europe. Net finance costs for the three months ended August 31st, 2022 were 1.9 million compared to 2.3 million for the comparable period of 2021. Net finance costs in the third quarter of 2022 included interest of $990,000 on the senior convertible loans and the new term loan announced in July of 2022 versus interest of $847,000 on the convertible debenture in the third quarter of last year. Net finance costs also included a decrease in expense of $500,000 in the third quarter compared to 612,000 in the comparable period in 2021. The remainder of the difference can be explained by a gain on the repurchase of the convertible ventures in July, as well as a smaller foreign currency loss than in the same period last year. So given the increase in revenue and the relatively lower increase in expenses, net loss for the third quarter of 2022 amounted to 7.5 million compared to $9.5 million for the same period last year. The loss in 2022 is also impacted by non-recurring severance costs and fees related to the decision to exit the European market for Tragarso of $900,000. We ended the third quarter of fiscal 2022 with $36.5 million in cash, bonds, and money market funds. operating cash flows will be sufficient to finance operations and capital needs for at least the next 12 months from the consolidated statement of financial position date. As previously discussed, the company secured a new non-dilutive $100 million term loan facility with Marathon Asset Management, significantly strengthening our balance sheet. The first tranche of $40 million was drawn during the third quarter, which enabled us to buy back $30 million principal amount of convertible ventures. For the three-month period ended August 31st, 2022, cash flows used by operating activities were 4.4 million compared to 4.6 million for the same period of fiscal 2021. During the quarter, changes in operating assets and liabilities had a positive impact on cash flow 3.2 million whereas in 2021 these had a positive impact of 1.5 million. These changes were mostly attributable to positive impacts from lower accounts receivables, lower inventories and lower prepaid expenses and this was offset by lower accounts payable. As Paul mentioned we are confirming our fiscal 2022 revenue guidance to be in the range of 79 to 82 million and or growth of the commercial portfolio to be in the range of 13% to 17% as compared to the 2021 fiscal year. So with that, Paul will be back for final comments. But first, we will now open the call to take your questions.
spk01: Thank you. If you'd like to ask an audio question, please press star then one on your touchdown phone at this time. If your question has already been addressed and you'd like to remove yourself from queue, please press star then two. And as a reminder, please, you may also ask questions via the webcast in the submit a question box. Today's first question comes from Andre Udine with Research Capital. Please go ahead.
spk08: Hi, Paul, Philippe, and Christian. Just had a couple questions here. Just looking at this quarter in terms of SG&A, is that a good run rate going forward?
spk11: Yeah, it should be generally in line for the next couple of quarters, yes. Okay, that's great.
spk08: And then also just looking at the intramuscular formulation of Trigarzo, if this current study continues and it actually, the data looks good, would that study be sufficient to file a supplementary BLA? And when would you expect to file for FDA approval?
spk03: Yeah, Andrea, thank you for the question. I will ask Christiane to tell you more about the timelines and the filing strategy. But obviously, you picked up that this can be significant for Trigarzo. We have indications that the IV push will be well received. And as I said, we see a significant trend. developing for non-oral regimens, and I think that what we have coming up can be very significant. Christian, do you want to add a few things?
spk09: Absolutely. The study that we're doing with the IM is a copycat, exactly the same as the study that was done for the IV push. Therefore, we know that it's been approved based on that one study with the IV push, and the endpoint is really the C trough, the trough level of the drug, just before the following infusion. And the medical model or the PK model that was shown during AIDS conference showed great confidence that that study could be positive.
spk08: And when can we see that data then, Christian, around? When can we see the data?
spk09: Yes. Well, the last patient last visit or the last dose will be in November. Shortly after that, we will have an idea about the results. We need to do the PK analysis. It takes a few weeks. Then beginning of next year, we'll have the data and we'll be ready to submit the file to the FDA. In the fall? No, no, at the beginning of next year. The last patient last visit is in November and the time to do the analysis. Then first quarter of next year, we will have the data and we'll be able to submit to the FDA.
spk08: Okay, that's great. And also, just can I ask one other question here? So in terms of the annual WAC for both Egrift, could I maybe get the annual WAC price for Egrift and Trigarzo? That'd be great if you have that handy.
spk11: Well, I can give those to you. I don't have them handy, but for a grifta, it's $6,500 or so per month. Okay. And for tragarso, it's about $2,700 per two-week cycle. So it's $2,600 times $2,600. Okay. Perfect. Thank you. Thank you, Andre. Thank you.
spk01: And our next question today comes from Andrew Leno with National Bank. Please go ahead.
spk10: Yeah, good morning, and thanks for taking my questions. I have a few. I just wanted to start first with the TH-1902. So the first question I had there, I was wondering if you can share with us on the patient recruitment, what is the target for that, and where are we now?
spk11: The target enrollment you mean for the Phase 1B?
spk03: Yes. Okay. Yeah, well, as you know, you know, we have a basket trial now composed of 70 patients, seven zero. We have targeted very specific tumors for which we know the sort one expression is high. Now, we have a fast track designation which allows us to have ongoing discussion with the FDA. So we could modify this basket trial along the way if we can. There are companies that are modifying their phase 1B trials in many, many different ways. But Christian, we don't want to be releasing any specific numbers on recruitment at this time, but the target is to have 70 patients, correct?
spk09: Absolutely. Then the recruitment is going well for the study, and we're on target to complete the recruitment of this study. by the end of the first quarter of next year, then the recruitment is going well. That's great color.
spk10: Thank you. And the other question I had on 1902, I mean, you mentioned the partnerships discussions in China and how they're kind of tied to recruitment. I just wanted to kind of elucidate that a little bit. I mean, is it specifically patient recruitment level or is it more efficacy and results, right? Like, it's just trying to gauge when you could potentially have some news of that outlier discussion there.
spk03: Well, if I understood your question well, you're talking about TH1902 partnership. Yes, that's correct. So the TH1902 partnership is for Greater China only. And we've had discussions with many, many good companies And obviously, as we get closer to, you know, lighting up the signs of efficacy, some companies want to see more before obviously finalizing the deal. But we still have companies interested and impressed with what we have, you know, published so far. So we are in good shape for finding a partner for greater China. This is a good short-term way for us to create value for the enterprise. But at the same time, the way it goes is that the more data we'll publish, the higher will be the price for partnerships. So we can't lose by producing good data. We can only win. Christian, I mean, that's the bottom line, right?
spk09: Absolutely. And the discussions are going well with the different potential partners. Philippe, anything to add on this?
spk03: Thanks for your question.
spk10: Great. Thank you. Yeah, a couple more on, so moving on to the NASH, and the NASH discussions that you're having, I mean, any kind of color you can give in there in terms of what is being discussed with potential partners? Is it potentially more work that needs to be done by a THERA or a combination of THERA and a partner, or is it more regarding VFA formulation and Once it gets more resolved, we could see some development there.
spk03: Well, the NASH program, as I said, we've said for a couple of quarters now that we wanted to find a partner that would come with capabilities and resources. I said it in my speech. I think that this is the right way to act. We're acting in a very responsible way because the cost of running this trial is very significant. But what is very, very good is that you might have seen additional interest in that NASH space developing in the last couple of months, which is great. This is what we anticipated, but a year ago that was not the same context. And as such, we feel that there is more interest now for a discussion in this NASH space, which is a high on mathematical need, one of the big markets left And I think that any companies that will want to actually lean forward and identify late-stage compounds that are ready to go into the clinic will actually get to us. And that's where we come in. That's where we're having more meetings with potential partners. And I'm not sure I understood the last part of your question, but we've got all kinds of companies interested. Sometimes it's big pharma. Sometimes it's small-sized firms. The point is that by having... a more favorable context regarding is it possible to tip this over to an approval, it actually creates a positive environment for us to identify a partner. And there has been, as you know, some competitors and biotechs that have published some favorable data recently in that space, and I think that the context is way more favorable. So for us, there's all kinds of possibilities. You talked about the bacteriostatic water. That's very important because we need that. At one point, we need continuous sourcing of that. And you saw the key decisions that we made to be able to go ahead. And for now, we are going to actually file with our FA formulation as soon as we have completed the... the human factor study, but at the same time, if we were to find a partner now, we could actually start, Christian, the trial fairly fast, right?
spk09: Absolutely. In terms of the trial, we already have identified the CRO that can work with us, and as soon as we may be enough, and shortly thereafter, a few months, six months thereafter, we can start the trial.
spk03: So the point related to NASA that I want everyone to understand is that we are asking ourselves, How can we create value with this program? There's got to be a way we could create value without having to actually spend a lot of dollars. And I think that partnership is the way to go. How are we going to actually split the work? How are we going to actually address territories remains to be finalized. But I think that having a context now where the mission is possible is creating a favorable environment for partnerships. Okay, no, that's great, Collar. Thank you.
spk10: And one last for me is on the Tregardo IV push. And a two-part question there. The first one, can the patient switch quickly, or is there a transition with the current formulation? And the second part of that question is, when do you think we can expect to see contribution or a larger contribution from the IV push into the result? And that's it. Thank you.
spk03: Yeah, thank you for your question, because we're very excited about this. The PDUFA date was October 3rd. We delivered on time. It's well done. And, John, can you answer the question? So switches, how do you foresee the transition? And the second, is that the overall contribution from the IV push?
spk02: Yes, thanks, Paul. So it's the method of administration that's different. The product itself, there's not a different skew. So physicians and patients have access to it right now, and they can begin immediately. We have actually a POA plan next week. The sales force has been trained, and so they're going to be out there communicating this information to physicians right away. Does that answer your question?
spk10: The first part, I mean, are you able to share any kind of target? Were you expected to be the majority of the contribution, or is that still in the works?
spk02: Yeah, I mean, our research indicates that there will be increased utilization. Physicians and patients will have greater access to this, which will create an increase in market share, we believe. And that, again, can happen almost immediately because the product is out there now.
spk09: Sorry, just one further explanation. At the moment, the drug, when you infuse it, it has to be diluted. then it's not all clinic that can do that step. And now it could be the drug that will be just taken into a syringe and injected directly in the vein of the patient. And there are many additional clinics that before have to send their patients to infusion center that will now be able to do the administration of the drug. And we think that that will be a significant advantage both for the clinic and the patients.
spk03: Thank you, Christian. This is key. Access to potentially new clinics for patients You know, the administration of Huertra Garza is key, and we're counting on this, and we're looking forward to reporting back to you. Next question? That's it. That's it. Thank you. Thank you.
spk01: Thank you. And our next question today comes from Zimwe Ahn at Canaccord Genuity. Please go ahead.
spk04: Hi, team. Good morning, and thank you for taking my questions. I'm Ahn for Edward Nash. I would like to ask about the TH-1902 program. Based on your recent publication and prior dose escalation study results, is it fair to believe that breast cancer and or ovarian cancer will be the first indication for this drug?
spk03: Yes, well, thank you for your question and interest in our TH-1902 program. So, you know, obviously, you know, having different arms to our basket trial was done on purpose. But, Christian, what do you think? It's hard to say, I guess, what, you know, cancer is going to give us, you know, the first go.
spk09: Yeah, it is hard to say. And as we announced yesterday morning, there will be a publication, a poster publication, at an upcoming meeting, showing that the source interceptor is highly expressed in a number of cancers. And at the moment, the five cancers that we're targeting in the basket trial are all high-expression, which is in the area of about 80%, 85% or more, which is very significant to many other cancer targets. And in the basket, we also are recruiting small cell lung cancer target cancers. that are expressing the receptor of more than 90%. Then, at the moment, we're just waiting to see one or two good response in one of those cancer types. It's difficult to say which one it will be at the beginning, but it's going well.
spk03: Thank you, Kishan. That's very significant. The paper that will be presented at the end of the month in Barcelona will tell a lot about the SORT1 expression. We've been saying that this is a receptor that is very significant. that is highly expressed, you know, when the patient or the cancer is advanced. So that's going to be significant. But I'd like to remind people that we had, as part of the basket trial, two signs of efficacy coming out of cases of prostate. And that was not necessarily expected, as this one doesn't seem to be the one that is expressing the SORT1 receptor at the highest level. Yet we had, you know, early signs of efficacy. So the point is, is that As long as the receptor is playing the role that we think it's playing, I think the potential is enormous.
spk11: Just as a clarification, Paul, you said in the basket trial, it's in the dose escalation. In the dose escalation, I'm sorry.
spk04: Okay, that makes perfect sense. Thank you for the answer. can we assume that for like assuming positive data from the basket trial that in the phase two, the indication will be within the cancer types that are currently being evaluated in the basket trial? Is that?
spk09: I do believe that based on all of the animal data that we have done and based on the patient-selected, which is based on the high expression of the sorting receptor, that we should see signs of efficacy in some of those tumor types. And as we've discussed or mentioned before, and Paul mentioned that at the beginning, once we see signs of efficacy that could be two responses or more in one tumor type, we would be ready to do an amendment and discuss with the FDA to increase the number of patients and to initiate the phase two assignment design with an additional 25 patients as an example, and after that to move into the pivotal trial.
spk04: Okay, thank you. And when should we start to expect more data from the basket trial, please?
spk09: Well, as we mentioned before, it will depend in terms of the efficacy, but the end of the quarter or next year, within the next six months, we should be, we're expecting to have more signs of efficacy that we'll be able to announce.
spk04: Okay, thank you. Looking forward to that and the poster presentation at the end of the month. Thank you.
spk03: Thank you.
spk01: Thank you, Chen-Wei. Thank you. And our next question today comes from William Patzer with Bank of America. Please go ahead.
spk07: I think the last questioner actually followed up on the things I was interested in. One thing I might ask is, although enrollment is going well overall for the basket trial, are there any particular cancer types of which you're ahead or behind on enrollment or where it's particularly difficult to get the patients you need?
spk09: Christian? Well, it would be difficult to comment at the moment. It's like recruiting. We're trying to ensure that the pace of recruitment is similar in all cancer types. We're doing different activities with the sites, and we're also working on activation of additional sites in Europe, in Canada, and other in the U.S. So everything is moving in the right direction. And again, we're trying to recruit as many patients from the different tumor types that we have in the protocol.
spk07: Okay, thank you.
spk01: And our next question today comes from Doug Lowe at Lee Jones Gable. Please go ahead.
spk06: Yeah, thanks, operator, and good morning all. While we're talking about the oncology program, gentlemen, just one thing. If you have any update on status of development of oxalate in constant at 1904, presumably you'll be informed by data that you get from 1902. how you want to stratify the market with the two conjugates. But anyway, just wondered if you have any thoughts on how you might want to push that asset forward.
spk09: Christian? In terms of the 1904, what happened in the earlier, just before we initiated this study or the phase one with TH1902, we did an efficacy study in the animal model with 1902 in ovarian cancer. And you know 1904 was more for ovarian cancer. And the results that we have obtained with 1902 was as good, if not better, than 1904. And this is why we took DH1902 as a lead compound, because it showed very good efficacy in all tumor types tested so far. There's been a number of those. In terms of follow-up compound, we're talking about 1904, but as we mentioned before, we're looking also at other peptide drug conjugate as an example. it is known that docetaxel does not work in colorectal cancer. Then we decided to start working on PDCs with SN38 and Irinotecan to see if that could work better in colorectal cancer. It's in preclinical at the moment. It's moving well. And we are also working on potentially attaching other anti-cancer agents to our PDC.
spk03: So it's important to note, thanks for your question, but TH1902, gave us stunning results as part of the preclinical work that we've done. And that's the reason why we decided to concentrate our activities on this one. And that doesn't mean that we don't have the capabilities for conjugating other payloads as per what Christian just said. But stepwise, when it comes to this, for now, we want to be laser focused on accelerating the recruitment of patients as part of the basket trial.
spk06: Yeah, good feedback. Thank you. The second question, you spent quite a bit of time with other questions on the NASH indication, but as you know, you have abundant published data on fatty liver disease in HIV-infected individuals, and I was just wondering if specifically targeting on the HIV market and liver pathologies might be a subset indication that you might still be interested in pursuing independently, or is that now definitively off the table?
spk03: Well, thanks for the question. Where we are now is that we have support from the community of KOL in the NASH space, including also the agency in the U.S. We have good support for going into the general population. And I'd like to remind you that HIV patients, if anything, are more difficult to treat. So that's the way that our protocol has evolved. And our protocol now is ready to go, so it could go. And what we have decided to do, which we've said, is that we have embedded an interim analysis in our protocol, which would allow us to actually have interim data after the first 400 patients are treated. Christian, do you want to add any details?
spk09: Well, the only thing is that in our case report call, we will enroll also HIV patients, contrary to most of the other programs that are ongoing at the moment where there are sometimes exclusion criteria for the HIV patient population. That's the way we'll go at this stage.
spk06: Perfect. Great. And then actually the question for which I dialed it originally was with regard to the multi-drug-resistant HIV-1 infection market. And so, you know, to guard those sales, they're certainly trending nicely, and your main competitor, VIVS, Leucovia, also trending nicely. But it strikes me as, you know, both drugs are probably trending a little bit below what all of our original expectations would have been for market penetration into that space. So just a general comment on how you're seeing the macro environment for that indication. Is disease... incidence prevalence as high as you originally thought that it was. Are there any, you know, competitive next-generation protease inhibitors or antivirals that are still sort of being used to treat that indication? Any additional commentary on price points? Just, you know, whatever commentary you have just on market size and that's the ability for Trigarza to grow, you know, beyond existing quasi-stable levels. And I'll leave it there. Thanks very much.
spk03: Yeah, well, thank you for your question. As you know, recobia and also trigarzo are indicated for multidrug resistance. There's a significant unmet medical need for that, no question. You know, what is the ONTAP population? Is it 2,000? Is it 3,000 patients? We're not entirely sure. What we know is that trigarzo is much needed for patients facing resistance, and we're very excited, as I said a few times, with all what is developing in that space. What is developing in that space is a trend towards non-oral regimens, and we can be part of that. I think this is the exciting part, and being relevant is always first, whenever you actually market pharmaceuticals, and we are. And second, I think that if you take a look at sales, despite the great growth number that we have now, for the quarter now, we were reported 26% Tragarzo year-to-date 17. That's quite a jump, and we're excited about what we see. The IV push is going to help. John, do you want to provide additional color on market size for Tragarzo in its entire entity?
spk02: Well, we understand the market size, I think, fairly well. It's around 2,000 patients a year. Remember, in a highly treatment-experienced patient population, these patients are on three drugs, so Drugs like Recobia and other newer agents coming to market will typically be used in combination with Frigarzo. So it's, you know, it's not a single-sum game here. And there's increasing need in this space, and Frigarzo fits a great niche. Christian?
spk09: Maybe one additional thing. It's a good thing that now you have two drugs in this market, because before Gazumab, there hasn't been any new mechanism of action. to treat or to take care of that patient population. Patients were four or five drugs as an average. And now that you have two new mechanisms of action, I think that the switch is starting to go from those five to probably two drugs or two drugs plus another one. But there's more action and there's more voice of cheer to start talking about this patient population, which is a good thing.
spk06: Great. Thanks very much, Jensen.
spk01: Thank you. We have a follow-up from N.J. Leno in National Bank.
spk10: Hey, good morning. Thanks for the follow-up. Just a quick clarification I wanted to go over. When we're talking about NASH, I mean, Paul and Christine are saying that you can go right away or quick enough after a partnership to start a trial. But I was just going over the MD&A in the meantime. And it says the FDA has asked some questions on the modified protocol and they have not been approved yet. I just wanted to clarify that when you say that you can go quickly, would this be on the modified protocol or the original one? And as a second part, when would you expect the FDA to respond once you answer their questions? Thanks.
spk03: Do you want to take this one? I think that we are in discussions with, as I said, several companies for NASH. You know, the protocol that we have, we have received a study may proceed letter, so we could go with the original phase three. And what we have done is that we have embedded, you know, an interim analysis in the study. So, you know, we think that this is the best way to go stepwise to actually confirm that after 400 patients, we have already good results. signs that we can have an impact on the NAS score in fibrosis and or fibrosis. But today, from a partnership point of view, anything else to add?
spk11: Well, I think we did get some questions from the FDA on the protocol. They're not deal-breaking questions. They're just questions to adapt the protocol. But we're not finalizing the protocol because if we do have a partner, we will want to have their input, their final input on the protocol before launching the study. So, again, we got questions from the FDA. We can answer them, and we're in agreement with everything that they've submitted, but we're not finalizing until we have a partner and until we can agree with a partner on a final protocol. Okay. No, that's great, Calvert. Thank you.
spk01: Thank you. Ladies and gentlemen, this concludes the audio Q&A session. I'd like to turn it back over to the management team for any closing remarks and or webcast questions. Please proceed.
spk11: So on the webcast questions, there are quite a few, but they're all related to the enrollment on the basket trial, and so I think we've gone in details on that. So on that, I will turn it back over to Paul for closing remarks.
spk03: Well, thank you, Philippe. I hope that everyone can see the transformation of our technologies over the last two years. These strategic changes that we have carefully implemented are now firmly rooted and bearing fruit. We have, in spirit and practice, rebooted the growth potential of our two drugs while continuing to invest in the line extensions of these products. Additionally, while we continue to deliver solid performance in the commercial business, We've been given a strong vote of confidence and have fortified our balance sheet even further through an exceptional transaction with a major investor in healthcare. We believe that we will have a solid fourth quarter to finish the year strongly and are optimistic for the new year. And I'm happy to remind everyone that we remain focused on executing the basket trial and we believe we are only months away from the next catalyst. I look forward to our discussions. where we will begin rolling out the next steps for where management is taking into our technologies. Thank you, everyone, for being on this journey. I hope you've all had a wonderful start to the fall season and cooler temperature. Thank you again.
spk01: Thank you. Ladies and gentlemen, this concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
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