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spk08: Good morning and welcome to the Thera Technologies second quarter fiscal year 2022 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Elise McDonald, Senior Director of Investor Relations. Please go ahead.
spk07: Thank you, Andrea. Good morning, everyone. My name is Elise McDonald, and I recently joined Thera Technologies to lead the Investor Relations Program. I'm thrilled to be here and look forward to working closely with the amazing team at Thera Technologies, our investors, analysts, and capital market partners. I am especially excited about working with our outstanding management team and our exceptional board of directors. On the call today, you will be hearing from our president and chief executive officer, Mr. Paul Levesque, and senior vice president and chief financial officer, Mr. Philippe Dubuc. In addition, we will be joined by Dr. Christiane Marcellet, senior vice president and chief medical officer, and Mr. John Leisure, our global commercial officer, for our Q&A session. 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, results, levels of activity, performance, goals or achievements, or other future events or developments. In preparing these forward-looking statements, several assumptions were made by Thera Technologies and there are risks that results obtained by the company will differ materially from those statements. As such, the company cannot guarantee that any forward-looking statement will materialize and you are cautioned not to place undue reliance on them. Thera Technologies refers current and potential investors to the forward-looking information section of its management's discussion and analysis filing issued this morning and available on CDAR at www.cdar.com and on EDGAR at sec.gov. Forward-looking statements represent TheraTechnologies' expectations as of July 13, 2022. Except as may be 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. With that, I would now like to turn the conference over to TheraTechnologies President and CEO, Mr. Paul Levesque.
spk05: Thanks, Elif, and welcome to our team. Hello, everyone. I hope that everyone has had a good start to their summer. And thank you so much for joining the TheraTechnologies team for our update call today. As we enter the second half of the fiscal year, we are making progress in real time across all of our strategic imperatives. What I mean by this, and as you've seen from our latest press releases, is that we've been very focused on our efforts to move the corporate needle forward and hit critical milestones for our commercial business and therapeutic pipeline. We are executing despite challenging times, not only in the biocapital markets, but also the tough overall macro environments which have been affected by inflation, supply chain issue, and geopolitical turmoil that we are witnessing on a daily basis. This is why the updates that we have provided this quarter, and there have been many as of recent, are helping to distinguish Thera Technologies from other healthcare names. Operationally, not only are we surviving through these tough moments, we are thriving. We announced yesterday that we successfully received a binding commitment letter for a $100 million non-dilutive term loan with Marathon Asset Management. The credit facility significantly strengthens our balance sheet and will make it possible to rapidly buy back and cancel $30 million of convertible notes due June 2023 through private agreements with certain U.S. note holders. The financing stands as a testament to our unique investment proposition and a real vote of confidence from a world-class asset management firm that is well known for its excellence in producing risk-adjusted returns on behalf of their investor base. Marathon's investment in Thera is indeed a show of support, not only for our mission, our track record of execution, but also for the whole management team. This morning, we announced an update on our TH-1902 program, which highlighted our lead asset safety profile and tolerability. As Christian can further explain, the pharmacokinetics data observed in humans showed low levels of free-dose Hidnaxel, consistent with what was observed in the prior preclinical studies, leading to a better safety profile than the use of cytotoxic alone. As noted in the release, we established a safety profile at 300 mg per square meter, or 1.5 times the therapeutic dose of docetaxel alone. Notably, one patient with endometrial cancer achieved stable disease over a 33-week period and was able to receive 11 cycles of TH1902. This is a clinically meaningful result in late-stage disease, where they are very limited treatment options. We also had two advanced prostate cancer patients who had progressed on standard chemo or hormone therapy. Both showed signs of efficacy. The first patient achieved a confirmed partial response with a tumor mass reduction of 53%, and the other patient achieved a PSA response with stabilization of disease without any further progression. Given that, on average, patients received eight rounds of treatment prior to TH1902. We are very encouraged by this update. It is meaningful and gives us hope that we can help improve patient outcomes and change the lives of those touched by heart and very hard to treat cancers. Building on our oncology pipeline update, we are so pleased to note that the CQDM, Quebec Biopharmaceutical Research Consortium, has provided a new cancer research grant to validate the entire metastatic potential of Th1902. The CQDM, together with the Quebec Breast Cancer Foundation and Mitacs, announced a contribution of more than one million Canadian dollars for a new research project at Université du Québec à Montréal focused on several metastatic cancer models. In particular, this new investment will further expand our knowledge in advanced metastatic breast cancer. This public-private partnership complements Athera Technologies' annual investment in the development of our targeted oncology platform using Th1902 in breast cancer and could increase the spectrum of patients or cancer patients who might ultimately benefit from this new therapy. Now, let's look at this past quarter's event. As noted in today's earnings press release, we have executed on our strategic plans in the quarter including our decision to focus sales efforts on the U.S., which is our strongest core market. As announced in April 2022, we made the decision to return commercialization rights of Tragarzo in Europe to our business partner, TimeEd Biologics, who owns the molecule. A notice of termination has been sent to TimeEd, and the transition will be complete by the end of October 2022. Despite this decision, TAIMED remains a very strong strategic partner for us. While we had every intention of bringing TruGarzo to Europe patients, it became clear through pricing and reimbursement discussion with local governments that we would not be able to carry a viable and sustainable business in the region. We recognize the uncertainty this situation may have caused for key stakeholders, especially patients, and we remain absolutely committed to a smooth transition back to TimeEd, and will continue to provide all necessary support for them to make important decisions concerning European patients' access to Trogarzo, a treatment whose therapeutic benefits have been proven. The shift in focus to the U.S. and the time to make the appropriate operational transition narrows our revenue range to roughly the midpoint of our forecasted 2022 guidance, as we expect our top-line revenue to be within $79.82 million for the full 2022 fiscal year. Commercially, we remain on track with our financial goals as consolidated sales grew 8.3% to $19.3 million for the quarter. Reflective of the momentum built up in our sales strategy, year-to-date revenue grew 13.9% to $37.8 million, which puts us well within striking distance to meet or better exceed our target as fiscal year guidance. In looking at Q2 versus Q1 patient enrollment numbers for the year, Egrifta's enrollment grew by 48% and Trigarzo by 26%. Combined quarterly patient enrollment growth was 19% year over year We believe these meaningful increase was driven by the return of in-person patient visits in doctor's offices following the easing of pandemic restrictions. Supporting these solid top line numbers has been the onboarding of our dedicated commercial field force in the US, which is now complete. Moreover, we have made key additions across the company in line with our corporate strategy, and to support our ongoing and expanded projects. We are pleased to welcome new team members to Athera Technologies and look forward to their contributions and leadership in their respective roles. I think we have some of the brightest and best talent in the industry and the business, and I appreciate their hard work and dedication to the mission and purpose of our company. Exiting the first half of 2022, we continue to be pleased with the recapitalization of the company as it allows us to continue to grow our commercial business to scale. Furthermore, we believe this supports our future revenue growth, which we are driving through evaluating and extending the lifecycle management of our existing commercial products, while successfully moving our lead oncology asset through its larger basket trial. Additionally, outlicensing, development, and commercialization rights for TH1902 in Greater China continue to move forward. We are very excited to showcase our dose escalation data to further these discussions and continue to move forward with an increasing number of potential partners. Now, let me update the market with regards to lifecycle management of our commercial business at a high level. In March 2021, we submitted an amendment to the FDA to the instructions for use section that is included in the IGRIFTA-SV patient information. This followed some complaints the company received from patients related to the reconstitution of IGRIFTA-SV after its launch in 2019. Along with these new instructions, we now provide patients with detailed training through our call center, and the number of complaints have dropped dramatically. The FDA responded to our amendment outside of the timeline set forth in the regulation with a complete response letter asking the company to carry out a human factor study to ensure that patients reconstitute the product in the proper manner. We have recently initiated the study, which we believe will be carried out to the FDA's satisfaction and also within their imposed timeframe of one year. This request does not affect the commercial availability of a GRIPTA SV. As previously announced, our intention was to file an SBLA for the FH formulation by the end of the first quarter of calendar 2022. Unfortunately, the issue around the global supply of bacteriostatic water for injection required for the reconstitution of the FH formulation has not been resolved. According to the FDA website, the estimated recovery of supply of bacteriostatic water is scheduled for October 2022. In addition, since the FDA has asked us to perform a human factor study for the reconstitution of Egrifta SV, we have proactively decided to carry out this study before filing the SVLA for the F8 formulation. As such, We will be filing the SBLA for the F8 once we have consistent sourcing of bacteriostatic water for injection and have completed the human factor study. Now, I'd like to provide an update on NASH. The NASH program is still on pause pending the sourcing of bacteriostatic water and the securing of a partner with resources and capabilities. After internal discussions and to further de-risk the Phase III trials, The company has submitted an amended protocol to the FDA. The new protocol, Phase 2B-3 Seamless Study Design, includes an interim analysis of the first 350 or so patients. This data will be analyzed by a data monitoring committee to assess the efficacy of the Samorlan and will allow us to generate hard endpoint data on NAS score and fibrosis. A decision will then be made whether to continue the study until the full number of patients, 1,094, have completed 18 months of treatment. The FDA has agreed to this redesign protocol. We continue to have discussion with potential NASH partners and are very encouraged to see renewed NASH interests and recent industry partnership announcements. Finally, on Tragarzo, an FDLA was filed with the FDA in the fourth quarter of 2021 for the company's IV push mode of administration for the treatment of HIV patients. The FDA has accepted our filing and has provided a target date of October 3rd, 2022 in accordance with the Prescription Drug User Fee Act. Theratechnologies and Tymid are also evaluating an intramuscular mode of administration for Trigarzo within the TMB-302 study. This trial is now fully enrolled, and we expect completion of the study in the second half of 2022. That covers our updates for the quarter, and I would like now to pass the call to Philippe, our CFO. Philippe?
spk04: Thanks, Paul. So I will review the financials before I turn the call over to the operator to start the Q&A. So consolidated revenues for the three-month period ended May 31st was $19.3 million compared to $17.8 million for the same quarter a year ago, representing a year-over-year increase of 8.3%. For the second quarter of fiscal 2022, net sales of Egrifta SV reached $11.4 million, compared to 10.3 million in Q2 of the prior year, representing an increase of 10.3% over the second quarter of 2021, due to the combined effect of a higher number of units sold and a higher net selling price. In the second quarter of fiscal 22, Tragarzo net sales amounted to 7.9 million, compared to 7.4 million for the same quarter last year, representing an increase of 5.5%. Higher sales of Tragarso were a result of a stronger performance in the United States, where we recorded 14% growth compared to the same quarter last year. Tragarso sales were, on the other hand, hampered by lower sales in Europe as a result of a weaker overall pricing environment. In Q2 2022, cost of goods sold was 7.8 million compared to 4.7 million for the same quarter last year. The increase in cost of goods sold was mainly due to a one-time charge arising from the non-production of scheduled batches of Ingrifta SV that were canceled due to the planned transition to the F8 formulation of tesamorelin. Cost of goods sold was also impacted by higher sales of both Ingrifta SV and Tragarso, but were generally in line on a percentage basis with prior periods' costs. R&D expenses amounted to $11 million for the three-month period ended May 31st, 2022, compared to $6.4 million for the same period last year. The increase is largely due to higher spending related to the ongoing Phase I trial of Th1902. In 2022, we have also initiated important studies related to medical education and real-world patient follow-up in the HIV field namely the VAMOS and PROMIS trials in the US. Increased spending in R&D is also related to the ongoing trial evaluating the intramuscular form of administration of Tragarzo, which has reached full enrollment and is on track for completion later this year. Selling expenses amounted to $15.4 million for the second quarter compared to $6.9 million for the same period last year. This increase is mainly due to the accelerated amortization of the rights associated to the commercialization of Targarzo in Europe, following our decision to terminate our commercial agreement with TimeEd for this territory. This represents a non-cash charge of $6.4 million. The increase in selling expense also includes one-time costs related to the setting up of our internal field force in the United States, as well as spending on new initiatives implemented in 2022 to increase awareness of our products in the North American market. G&A expenses in Q2 amounted to $4.8 million compared to $3.8 million reported in Q2 of 2021. The increase in G&A expenses is largely due to increased overall business activities in 2022 compared to 2021, as well as to key hires in North America to support the implementation and management of our internal field force in the U.S. Net finance costs for the three months ended May 31st were $1.6 million compared to $1 million for the comparable period in 2021. Net finance costs in both the second quarter of 2022 and 2021 include interest of $833,000 on the senior convertible notes issued in June of 2018. Net finance costs also include the depreciation expense of $544,000 in the second quarter of 2022, compared to $608,000 for the comparable period last year. The remainder of the difference can be explained by a foreign currency loss in 2022, as opposed to a foreign currency gain in the same period of last year. Given the increase in revenue and the increased expenses, the impairment of the Tregasso commercialization rights for the European territory, as well as other non-recurring charges explained earlier, net loss for the quarter amounted to $22.7 million compared to $6.4 million for the same period last year. We ended the second quarter of fiscal 22 with $32.5 million in cash, bonds, and money market funds. The company that believes that its cash position and future operating cash flows will be sufficient to finance its operation and capital needs for at least the next 12 months until the consolidated statement of financial position date. Furthermore, subsequent to May 31st, 2022, as announced yesterday, the company secured a new non-dilutive $100 million term loan facility with Marathon Asset Management, significantly strengthening our balance sheet and allowing us to rapidly retire $30 million principal amount of convertible to ventures. Funding of this first tranche of the term loan facility for $40 million is planned before the end of July, at which time we will retire the $30 million of convertible notes, which we will acquire at a discount to par. When the three-month period ended May 31st, cash flows used by operating activities were $11.7 million compared to $2.8 million in the same period of fiscal 2021. In the second quarter of fiscal 22, changes in operating assets and liabilities had a positive impact on cash flow of 10.6 million, whereas in 2021, these had a 2.1 million positive impact on cash flow. These changes were mostly attributable to positive impact from lower accounts receivables, lower prepaid expenses by approximately a million dollars each, as well as higher accounts payable and accrued liabilities of $7.1 million. We are tightening our fiscal 2022 revenue guidance range of $79 to $82 million for a commercial portfolio to be in the range of 13% to 17% as compared to 2021. The adjustments reflected our lower expectations from sales of Tragarso in Europe as we begin the transition period of commercial rights back to timing. With that, Paul will be back for final comments. we'll open the call to take your questions. We also have questions from the webcast, so I will moderate these after the analysts. Operator?
spk08: We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Once again, that was star then 1 to ask a question. And at this time, we will pause momentarily to assemble our roster. And our first question will come from Edward Nash of Canaccord Genuity. Please go ahead.
spk00: Hi. Good morning. Thanks for taking my questions, guys. So I just wanted to understand, so we were basically just about flat, maybe a little bit down on a grifta, quarter of a quarter sequentially. And just for modeling purposes, just kind of what are the thoughts as we go out for the rest of the year? Would we expect more of the growth in you hitting your revenue estimate numbers to be coming from U.S. sales of Trigarzo, or do you expect to see a little bit more of a bump up on grifta?
spk05: Well, thank you, Ed, for the question. I'm glad you picked this up because, you know, let me just highlight a few numbers here again. The year-to-date growth for EGRFTA after six periods is almost 22% in dollars. And what I said in my speech is that Q2 over Q1, this year, the growth of EGRFTA was almost 48%. So the drug is really carrying a significant momentum. You know it's our most profitable product, and we have a great deal of aspiration for it. But having a drug that has been on the market for a number of years, growing at 22% in sales after six periods is a great deal of satisfaction to me. So John, do you want to provide additional comments?
spk04: On top of that, we achieved those results during a period of transition with our sales force. We just launched a new sales force in May. We're starting to see some real benefits from that. Although we've had good growth for the first six months, we expect further momentum in the second half of the year.
spk00: That makes sense, and that's really helpful. And just the last question I had is just, could you help me understand, so I know that the issue with the F8 formulation is related to the bacteriostatic water, but how is that different than what we're currently seeing with the Grifta SV? Because when you send Grifta SV, bacteriostatic water is included with the SV formulation, right, for reconstitution? So I'm just trying to understand how the bacteriostatic water has not affected the Grypta SV availability as well.
spk05: Thanks, Ed, for your question. That will allow us to clarify. There's a big difference between the F8 and the F4. The F8 is once a week reconstitution, and that's why you need to have special waters, quote-unquote, to ensure that the solutions will actually be for a full week. Christian, do you want to provide an additional comment?
spk03: Yeah, absolutely. This is bacteriostatic water for injection that we use because it is one vial for seven doses. Then you poke the vial on a daily basis, then you need the bacteriostatic in the vial, which we don't have for DF4 because DF4 is a daily reconstitution. Then you add the water, you take your injection, and you throw everything in the garbage. That's the main reason of the difference between the two.
spk00: Got you. Great.
spk02: Thank you guys so much. Appreciate it.
spk08: The next question comes from Andre Uden of Research Capital. Please go ahead.
spk01: Thank you. Good morning, everyone. Just assuming the push dose of Trogarzo is approved October 3rd, when do you expect to launch it and do you anticipate taking down any of the current formulation inventory prior to launch? Thank you, Andre.
spk05: You know, we do have a PDUFA date of October 3rd, as we said, and I just want to insist, you know, we're going to maximize the launch of this formulation. I think it's going to be communicating ease of administration to our users and patients. John, do you want to provide colors on the launch?
spk04: Well, yeah, we're preparing to launch in Q4, October timeframe, but it's important to recognize that the While the dosage, the method of administration may be different, the actual dose of the product is the same. So there's no need to run down inventory.
spk01: Okay. That's great. And also just looking at the F8 formulation and the sterile water situation, once you do get consistent supply, what human study do you actually need to do and about how long do you think that would take before you can then file and SBLA from when you start the study. Thank you.
spk05: Yeah, thank you. The human factor study that we have proactively decided to do with the F8 is identical as the one that is now required by the FDA on the F4. Christian, the methodology is very simple, right?
spk03: Yeah, it is simple, and it is something we are a company that has the expertise in this field, and it's a study that will be completed on time for submission. But I want also to address the other part of your question in terms of which study was done. In terms of the bioequivalence, we have done the exact same thing as what was done for the F4, and that study is already completed, and while we have shown bioequivalence between the F8 and the F1, then this part of the file is completed.
spk01: Okay, that's great. And about how long would that take about, do you think, to run that new study?
spk03: What do you get? The human factor study, we're thinking about a period of about 12 months to run a study like this one because there's two parts. There's a part that's an informative part. After that, we need to get feedback from the FDA, which is about 70 days. And after that, we do what we call the summative study and submit the results to the FDA. And 9 to 12 months should be completed. Okay.
spk01: Great. And Christian, this was also, since I have you here, the 1902 data looks promising. And I was just wondering, what criteria did you use to actually select the cancer indications that are developed for the basket trial?
spk03: Yeah, for the basket trial, well, for the dose escalation, we're, first of all, we're very encouraged by dose results because those were all comers. and as you know, we start at the very low dose. We have patients that receive 420, and we have to stop treatment because of some of the toxicity that we've seen, and those are very advanced patients. The average number of cycles that they have received is eight, and the fact that we see good signs of efficacy in three patients is very good. For the basket trial, what we have done, since we acquired the technology, we have done a lot of biopsy analysis, we call this TMAs, and on one slide for the microscope, you get something like 300 biopsies of different patients. And this is the way we selected the patient for the BASCAT trial. We took the patient that are the highest, or tumor type, that are the highest expression of the sortion receptor, mainly TNBC, hormone receptor positive, breast cancer, ovarian cancer, endometrial cancer, melanoma. But we also included a basket in the basket based on very encouraging results in prostate cancer. There will be additional patients with prostate cancer that will be enrolled. Thyroid cancer is a very high expression of the short-chain receptor. It will also be included as well as small cell lung cancer. And if we find the basket of the basket is to have an investigator to enroll additional patients, that would be high expression of the receptor.
spk05: Thank you, Andrew, for your question. But just to summarize, because it can be complex, Christian has selected different tumors for which we know the short-worn expression is high. So we are increasing our likelihood of getting early signs of efficacy fast. And according to what we're going to see, since we have a fast-track designation, should we see back-to-back efficacy in one cancer or tumor or we will strategize and interact with the agency to see how we can accelerate the development of our compound for at least one indication. So we've designed the basket trial to be large, but this is going to be, you know, helpful because, you know, all of those tumors, from what we know, are expressing SORT1 at a very high level.
spk01: That's great. Thank you.
spk08: Once again, if you would like to ask a question, please press star, then 1. And our next question will come from Andrew Leno of National Bank. Please go ahead.
spk06: Hey, good morning, and thanks for taking my question. The first one, I'll continue with 1902, and the question I had there for Christiane, perhaps, is can you talk a little bit, and congrats on those encouraging results that you got, can you talk a bit about the assessment of the treatment response in prostate cancer And what is the most accepted one? I mean, is it reduction in lesions, reduction in PSA, OS, or PFS, or any of those? Thank you.
spk03: Yeah, absolutely. The prostate cancer patient that was enrolled in this study, first of all, was very advanced in the treatment. This is a patient that received a total of 10 different treatments before being enrolled in this study. The last two treatments that he received before enrollment, one was docetaxel and received only four cycles before disease progression. And after that, the patient received cabazitexel, which is another taxane, and received only two cycles. After that, the patient was enrolled in the study with our product is linked to docetaxel. And what we've seen, according to the RISIS criteria, is a partial response. And the total reduction in the tumor size, the one that we target initially for assessing the response, was 53%. And that's very significant based on the fact that that patient was already progressing on docetaxel and cabacetaxel. The second patient, in terms of prostate cancer patient, was also a patient that was advanced in treatment, received three prior treatments, and had disease progression on hormone therapy. The patient was enrolled in this study, and what we've seen, the patient was enrolled at 420 mg per m2, received three cycles, and after that, two cycles at 300. This is at the time that we started to lower the dose to aim at 300 as the basket trial goes, and this patient had a significant response on PSA. The PSA level returned to the baseline volume in the normal range, and the patient that's stable disease with a slight reduction in the one-digit reduction. But something which is important is that the patient did not stop the study because of disease progression. The patient stopped the study most likely because of some of the toxicities at 420. The patient had a bit of neuropathy, which we don't see at 300 so far. Then that's the reason why he stopped. And those results are very encouraging. And maybe finally, regarding the endometrial cancer patient, This is also a patient that had received before the entry in our study a combination of carboplatin and pectetaxel. The patient couldn't receive those cycles or that treatment for more than three cycles. And the reason, because the patient had adverse events. Then the patient after that was switched in our trial. The patient started at 60 milligram. That was one of the early patients. But the patient was like, we have seen disease stabilization. And we were able to increase, because you know that in that part of the study, we can do dose escalation on patients after those other cycles are up. Then that patient went up to 360 milligrams per meter squared for a total of 11 cycles, 33 weeks with stable disease. And once again, the patient did not stop the study because of disease progression. The patient wanted to go back to a normal life. We discussed with the site. It doesn't look like the patient had any significant adverse events linked to the drug, but it's only a question of getting back to a normal life. That's why we're fairly happy with those three signs of efficacy and very difficult to treat patients. Okay.
spk06: Thank you for that, Christian. And just one follow-up. I mean, would you want or would you have to see PSA reduction to treat? to call it, let's say, a success or a proper response, or just because it's so advanced, that does not necessarily have to be the case?
spk03: It's usually a combination of both, but if you have a reduction in tumor that lasts for a long period of time, this is a response, especially in that patient population, especially in a patient that was progressing on docetaxel. Then we will continue now to enroll patients in the basket trial, and if we see similar efficacy in similar patients, This is where we will have to make a decision as to how we move forward in one of those cancer type. And we'll certainly have a discussion with the FDA at some point. Will it be to increase from 10 to 25 patients and after that move to phase two? But as Paul is saying or said before, we're still like on a fast track and our goal is to be fast to market. Then we'll discuss with experts and the FDA to ensure that we have the proper design to get to market as fast as possible.
spk06: Thank you very much. One more question. It's more on the cost side. I'm wondering if you guys can talk a bit about the human factors study, if you have any cost estimates, and then overall cost for the company. How do you see them progressing for the second half of the year? And that's it for me. Thank you.
spk05: I'm not sure, Andrew, that we picked up your questions, but I just want to say it again. We have implemented, Christian has implemented implemented some solutions that actually has reduced the number of complaints dramatically. That's what I said, and that is true. However, the FDA has asked us just to conduct a human factor study to ensure that the leaflet that is in the patient's hands is absolutely perfect. And the human factor study is not a great deal. This is something that many other companies have to do. And we have already appointed, you know, a firm that does that all the time and succeeds. So, Christian, I mean, just like, you know, for the F8, we're going to do it proactively. The F4, we have to do it. But the point is, is that this is not a great deal.
spk03: No, this is, the companies that have, or many other products, the company that was selected was successful in 20 of those HFS studies. It is really to enroll, like, volunteer and patients that will mimic or that will reconstitute the drug to ensure that they inject the proper volume of drug at the end of the study. That's something relatively easy to do.
spk06: Okay, no, thank you. And what would you estimate the cost could be for the HFS study?
spk04: Well, the cost of these trials are about, you know, depending on how long they take, it's between $650,000 and $800,000 to carry out
spk06: Okay, that's not bad. And then the other part of the question, for the overall cost of the company that I was asking, how do you see them progressing for the second half of the year? Do you see them more stable or accelerating a bit if you pick up patient recruitment?
spk04: On the trials, the oncology trial can keep progressing a little bit, but not all that much. And the rest of the company, we've had a lot of one-time costs in the first half of setting up the trial. the commercial operations. The intramuscular study of Trigarzo will also decelerate in spending because full enrollment has been reached and we're winding that down. So costs will be stable for the rest of the year. Thank you very much. That's it for me.
spk05: Thank you for your question. And I see that there's a great deal of interest this morning about the TH1902 release that we had. I just wanted to stress something again before we take the additional questions we have. The dose escalation for us was very, very interesting. But the goal of a dose escalation, first and foremost, and I just want to say it again, is to determine the dose and the safety and durability at that dose that you're going to use in the basket trial afterwards, or the Phase 1b. And we're very, very happy to have seen that the free-dose Cetaxel level is very similar to what we saw in the animal model, which tells us that there's something going on probably through the SORT1 receptor as per the preclinical model. So this is very encouraging. And on top of that, what Christian highlighted is that we picked up three patients where we certainly have very interesting signs of efficacy that obviously needs to confirm or to be confirmed in the second part of the phase one. But, you know, for now, we're very pleased, and the market was, you know, in a waiting mode for this, and we wanted this morning to communicate as much as we could at this time on the escalation track.
spk02: Okay, so there are no more questions from analysts.
spk04: So we do have a few questions from the webcast. The first one is if we can be more clear on the toxicity profile that we've seen at the 300 dose. So you mentioned no DLTs, but are there any AEs or serious adverse events that we've seen so far at 300 doses?
spk03: Yeah, in terms of the 300 dose at the moment, as mentioned in the question, DLTs after the first cycle, we didn't see any serious adverse events on the patient that's received that treatment. And none of the patients stopped the treatment because of adverse events. We have seen, as mentioned before, 420-some DLTs. visual equity changes. We have one patient that had adverse events related to what we see in the eye to some extent, but now we're putting preventative measures like eye drops, and this is something similar to what's happening also with the ADC. The ADCs are leading also to those adverse events, and it's not something that is of a concern by us at this stage, neither the investigators participating in the trials.
spk04: Okay, and there's a corollary to that. Where do you think the 420 milligram toxicities came from if there isn't much free docetaxel?
spk03: Well, the toxicities are still linked to some extent to docetaxel, and one of the toxicity that we have seen is neuropathy. And we know that the short-circuit receptor is also expressed on neurons, and that could be the link for the neuropathy, similar to what we've seen. We've seen one grade four neutropenia that lasted for more than seven days, and once again, it is linked also to dose FXL, but this is not something that we have observed at this stage at the dose of 300.
spk04: And here's one, any info on the partial response patient's total tumor burden changes?
spk03: Yeah, maybe I would explain. To have a partial response, according to the RISIS criteria, what we do, we measure the total tumor size. And sometimes there's more. There are metastases. And in the case of that patient, we did the first CT scan after six weeks, and there was a repeated CT scan. And to confirm the partial response, you need to have a follow-up CT scan following the initial response. And the total burden, like the decrease, was about 53%. The exact size and total size of the tumors, I don't remember. But I can say that one metastasis disappeared completely from the CT scan. Then that's the sign which is very encouraging. And we mentioned also in the past that the source and receptor is often more expressed in metastasis. And those are very encouraging signs that are linked with our mechanism of action.
spk04: Okay, thanks, Christian. The others have been pretty much answered in your comments. There's one that is inquiring about the agreed price with the convertible buyback. We're not disclosing it. These are private purchases, but you can assume that it's around a 5% discount to PAR that we were able to negotiate. So there are no more questions at this time. So operator, I'll turn the call back over to Paul for closing remarks.
spk05: Thank you, team, and thank you guys on the line for your questions. I know this is exciting time for us. Today's remarks ran a bit longer than usual due to all of our great progress. I just wanted to conclude with some important key takeaways here in this early midterm of the 2022 year. Thorough Technologies is currently hitting on all of our execution marks in realizing the future of the company in the here and now. Most recently, the validation that we received for our investment thesis and the associated capital infusion that came with it is a real vote of confidence. This is the case despite the challenging market for small cap biotech where financings are just not getting done. The second important takeaway is that we have successfully reached the end of the dose escalation portion in TH1902 and have established our go-forward dose. We now expect new data to be potentially released in the back half of 2022 with regards to early efficacy of our basket trial. This will be followed in Q1 of 2023 by a presentation of the complete data set for the dose escalation study which has already established those limiting toxicity in addition to the go-forward dose. As you have witnessed from the strategic adjustments to our commercial business development pipelines and lifecycle management of our franchises, we are optimizing our capital allocation in a difficult marketplace to create an efficient organization with the critical infrastructure to succeed across all of our endeavors. With this, I look forward to seeing everyone on the next update call. Thank you. Have a great day and a great summer.
spk08: The conference is now concluded. Thank you for attending today's presentation and you may now disconnect.
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