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spk01: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to TheraTechnologies' fourth quarter and annual fiscal year 2021 earnings call. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session with the analysts. Instructions will be provided at that time for you to queue up for questions. Following the analyst Q&A session, Investors wishing 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 any time. I would like to remind everyone that this conference call is being recorded today, Thursday, February 24, 2022, at 8.30 a.m. Eastern Time. I will now turn the call over to John Mullaly. LifeSci Advisors. Mr. Mullaly, please go ahead.
spk06: Thank you and welcome. Mr. Paul Levesque, President and Chief Executive Officer of Thera Technologies, and Mr. Philippe Dubec, Senior Vice President and Chief Financial Officer, will be the speakers on today's call. Before Paul begins his remarks, I've been asked by Thera Technologies to read the following message regarding forward-looking statements. I would like to remind everyone that Thera Technology's remarks today contain forward-looking statements about its current and future plans, expectations and intentions, results, level 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 actually obtained by the company will differ materially from those statements. As a consequence, the company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. Ferris Technologies refers current and potential investors to the forward-looking information section of its management discussion and analysis issued this morning, available on CEDAR at www.cedar.com and on EDGAR at www.sec.gov. Forward-looking statements represent Veritechnologies' expectations as of February 23, 2022. Except as may be required by securities law, Veritechnologies does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. I would now like to turn the conference over to Paul.
spk02: Thanks, John, and good morning to everyone joining the call today. I wish you a warm welcome and to express our thanks for taking part in Thorough Technology's journey. This has been an incredible year of milestone achievements in addition to the progress made in support of our commercial franchises. We want to focus your attention today on four key updates which we believe are the major drivers in propelling our success in the new year. The drivers include the build-out of our own commercial sales and medical teams, our full year 2021 results, particularly our second half performance versus that of the first half, updates for our lead oncology asset, TH1902, and the progress in our NASH program. As we already draw near to the close of Q1 of our new fiscal year, we carry with us the full momentum of four successful quarters of progress. What stands out? the most about Thera Technologies is just how differentiated we are in being an early stage biotech as we possess both late and early stage assets. Moreover, in addition to our pipeline development, we're also a drug company with mature commercial brands and a strong strategy to grow our franchises for years to come. I am mentioning this now since we have recently announced the strengthening of our global commercial capabilities through the launch of an internal field force. Our commercial business has reached critical mass, and we look forward to kick-starting our new stage of growth with this initiative. At present, we are finalizing our employment offers to top performers of the current field force who will be joining the company from our partner contract sales organization. This will be in addition to the hiring of new experienced sales representatives in order to create a truly competitive field force. We do believe this will ultimately lead to superior performance and faster growth from our commercial portfolio. In parallel to this push to better serve our patient and healthcare providers, we're also strengthening our medical affairs team. We fully expect the expansion of our disease awareness initiatives will ramp up knowledge of the therapeutic field we are invested in across the patient and provider landscape. For example, we expect our PROMIS trial in North America and Europe for Truvarzo and the VAMOS study for GRIF-DSV will contribute to helping healthcare providers identify patients in the diseases that we treat. In building real-world evidence for our assets, we are reinforcing the value they provide to patients, encouraging them to start and stay on therapy. We are optimistic for what lies ahead in the new year, propelled by positive post-COVID momentum, especially now that face-to-face meetings have resumed across most states. In making the decision to transition from a contract field force model to one staffed by Thera Technologies employees, we are confident that the hiring of our own field sales and medical affairs teams will significantly improve the important task of engagement with our customers. We believe that both recruitment and retention of top talent will also improve as we begin this new chapter of the company's corporate development. In summary on this topic, as our new sales and medical affairs colleagues are integrated into the fold, I would like to express how delighted we are to welcome these key members of our contract field force into the Thera Technologies family. While 2021 overall growth was significant, 5.7%. The second half grew 10% compared to just 1% in the first half versus 2020. In addition, new patient enrollment across our franchises grew a blended 24% in the second half of the year as compared to the same year ago period. This is a very good sign that with post-COVID promotion, we are getting traction in the marketplaces. Growing revenues and the execution of our commercial strategy in the new year remains a high priority as we move swiftly to catch up with demand for Travarso and Egrepta SV in patients with unmet needs. As a side note, capital access is very difficult in the current volatile biotech market. However, revenues from our commercial business serves to support and de-risk our pipeline development. This relative advantage of being a revenue-generating enterprise is that our commercial business allows us to be more selective in our capital allocation choices. On the clinical track, we're happy to report that our oncology program is close, very close to establishing the maximum tolerated dose, or MTD, and to initiating the Part B of the Phase I trial of TH1902. We are now in the final stages of TH-1902's Phase I, Part A dose escalation study, evaluating our lead investigational peptide drug conjugate for the treatment of certain and positive cancers. In total, four patients in the trial have been administered significant doses of TH-1902 at 420 mg per square meter, equivalent to nearly two times the indicated therapeutic dose of docetaxel. To date, We have observed a dose-limiting toxicity, or DLT, in one patient, consisting of a grade 4 neutropenia lasting more than seven days, as well as other adverse events after more than one cycle at 420 mg per square meter. As a result, we have decided to pursue the study at the lower dose of 300 mg per square meter, or approximately 1.5 times the usual dose of docetaxel. We currently are enrolling patients at this lower dose to confirm the absence of DLTs following the first cycle. Once MTD has been established, a study protocol allows for immediate initiation of enrollment of the larger open-label basket trial. The basket trial will further assess the safety and durability of Th1902. Additionally, the preliminary anti-tumor activity of Th1902 will be evaluated for our patients as per the response evaluation criteria in solid tumors. Based on additional research we have conducted on the SORT1 receptor, we have submitted an amendment to the Phase 1 protocol to the FDA to include the following solid tumor types. Hormone-positive breast cancer, triple-negative breast cancer, ovarian cancer, endometrial cancer, and melanoma, with approximately 10 patients per tumor type. In addition, one arm will be added to include a mix of tumor types, including thyroid, small cell lung, prostate, and potential other high-sortiline-expressing cancers, with 15 patients in total. The original trial design consisted of 40 patients across a selection of solid tumors, including colorectal and pancreatic cancer. The plan now is to enroll a total of approximately 70 patients in the basket trial in order to evaluate the potential anti-tumor activity of TH1902. As previously mentioned, we're also exploring the possibility of out-licensing development of commercialization rights for TH1902 in Greater China. We are very pleased to report that there has been solid interest on the part of Chinese companies and that discussions are ongoing with a number of different pharmaceutical and biotech companies. In addition to the geographic exposure gained from these dialogues, we're also in exploratory talks with companies seeking to leverage our peptide as a carrier to target cancer cells through short-worn receptors. Looking at the potential of TH1902's internal development, out-licensing and partnering opportunities We are optimistic in our approach to managing the development of TH1902 for the treatment of solid, metastatic, and refractory cancers, both in the near and medium term. Moving on to our NASH update, you may have recently seen in the news that a company with interest in NASH published very interesting data. The investment community subsequently reacted very favorably. Based on this and other recent data published in the area of NAFL and NASH, we are seeing renewed interest and believe more than ever in the prospects for Tissa Moreland as the treatment for NASH, as a treatment for NASH as experts continue to gain awareness of Tissa Moreland as a NASH treatment option. While we continue to seek partnering and non-dilutive financing options for our Phase 3 NASH program, The company will submit in the upcoming days an amended protocol to establish an interim analysis of primary endpoints. The new trial design will include a seamless Phase 2B-3 study where the first 350 of the planned total 1,094 patients' data will be analyzed by a data monitoring committee in order to assess the efficacy of Tessa Moreland on a smaller subset of patients. A decision will then be made to proceed with the study's remainder of the planned total 1,094 patients. While this doesn't change the total number of patients required to seek accelerated FDA approval of tesamortin for the treatment of general NASH, it will serve as a substantial de-risking event and will inform the continuation of enrollment while providing an indication of benefits to patients. In the meantime, we continue to seek an ideal partner with both the credibility and capability to assist us with the NASH program going forward. And in covering all bases, we're also seeking financing alternatives to execute the trial up to the interim analysis on our own. Before I turn the call over to Philip, I want to note that our objectives for fiscal 2022 remain crystal clear. From a development perspective, we're also continuing our line extension efforts to further develop the benefits or convenience of our products, which includes new formulations and mode of administration. In total, our program management strategies to develop the complete portfolio of assets with clear, immediate, near-term, medium, and long-term catalysts that will benefit not only patients' unmet needs, but provide entry and exit opportunities for investors alike. With this, I would like to turn the call over to Philip, who will provide a financial summary for the reporting period before moving to Q&A. Philip?
spk04: Thanks, Paul. Good morning, everyone. Consolidated revenues for the fourth quarter of our fiscal year 2021 were $18.8 million, down 1.9% versus Q4 of 2020. As I will explain later, our top line for the quarter was affected by a provision we are taking related to potential clawbacks in France, and which are directly related to our ongoing negotiations with the government for the reimbursement of Tragarzo. We are, however, pleased to report that revenues of Egrifta SV were $12.7 million a quarter, up 18.6% from the same period of last year. Increased sales of Egrifta SV were the results of higher unit sales and a higher NIP selling price, mostly the result of a combination of a higher gross selling price and lower rebates and chargebacks from government payers in the U.S. Cargaso revenues were $6 million during the quarter, down from $8.4 million in the same period of 2020. Unit sales were down 7% year over year and were mostly affected by lower new patient starts during the COVID-19 pandemic. We are currently seeing clinics reopen and face-to-face meeting with physicians increase as a result of the general reopening of the economy. We are confident that Tragarzo unit sales will start growing again in 2022, even if the recent short-term lockdowns related to the Omicron variant have affected the market in December and January. The bigger impact to Tragarzo revenues was related to a provision we needed to take in anticipation clawbacks related to early sales of Tragarzo in France. This provision is mostly related to the anticipated price to be negotiated with the French government, which is being affected by the agreed price of a competing drug. Negotiations with the French government continue and we believe we will be able to conclude these negotiations shortly. As our first quarter will end in the next few days, I can report that Tragarso unit sales have resumed growing after a difficult few quarters, and that Egrifta SV unit sales have grown in the 20% range from Q1 2020 to Q1 2021. So with this in mind, we are announcing revenue guidance for fiscal 2022 this morning, and are expecting sales revenue of between $79,000 and $84 million. Cost of sales in Q4 2021 was relatively stable at $6.4 million compared to $6.7 million for the same quarter last year. The decrease is mostly due to production-related costs, which were incurred in 2020 but not in 2021. R&D expenses amounted to $8.7 million in Q4 compared to $6.8 million for the same quarter last year. This increase is largely due to higher spending in our oncology program, including the phase one trial and the NASH phase three preparation, increased spending in medical and patient education, as well as higher medical affairs initiatives in Europe. The three-month period ended November 30th, 2021, Selling expenses have amounted to $8.2 million, compared to $6.5 million in the same period last year. The increase in selling expenses is largely associated with the addition of senior personnel in North America to build a stronger sales organization, as well as increased activities in Europe ahead of the launch of Targarzo in key markets. G&A expenses amounted to $3.5 million in Q4 2021, up slightly from $3.3 million in Q4 2020. The increase is mainly attributable to the overall increase in business activities and increased activity in Europe. In Q4 2021, net finance costs were $1.8 million compared to $1.4 million in finance costs in Q4 2020. As previously stated, net finance costs comprise of interest on the convertible notes, foreign exchange variations, as well as accretion expense, and are offset by interest earned on our cash balance. For the fourth quarter of 2021, we recorded a negative EBITDA of $5.5 million compared to negative $1.4 million last year. The difference is mainly due to the higher net loss during the quarter. So reflecting the impact of the capital raise during Q1 of 2021, we ended the year with cash and cash equivalents of $40.4 million. So Paul will be back for final comments, but first we will open the call to take your questions.
spk01: Thank you. To ask a question, you will need to press star one on your telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Once again, to ask a question, please press star, then one. Our first question comes from the line of Andre Uden with Mackey Research.
spk00: Good morning, Paul, Philippe, and Christian. I just had a few questions. When do you think we would see some Phase I 1902 safety data, and when do you think you would also start the Phase II-III NASH trials?
spk02: Okay, so, well, thank you for your question. TH1902, as we said, is about to finalize its maximum tolerated dose, and the basket trial, I think, is going to be following right after. Christian, do you want to provide additional color to that?
spk07: Yeah, what we mentioned is that we have seen some 1DLT at 420 mg per m2. We reduced the dose to 300 mg per m2. which is 1.5 times the dose of docetaxel when given or administered alone, and this is a very good dose. And now we're proceeding with the study, enrolling three patients, looking at DLT, and following three patients. After that, we'll be ready to open the BASCA trial. At this stage, based on the data that we have, we're not expecting any DLTs of 300, but that will be known in the next two to three months.
spk02: When it comes to your second question, Dinesh, we are about to file the amended protocol with the FDA. We expect a 30- to 40-day response from them. And following that, we'll have pretty much everything that is needed for us to actually clarify our plan forward. But this is a major decision that we've made and that we are announcing today because we You know, doing so will allow us, after 350 patients have been treated, to have heart endpoint data, which is very, very significant. And being able to go with the Phase IIb3-3 seamless protocol allows us to carry on with the recruitment of patients and therefore not waste time. So I think we're going stepwise now. First, to confirm that this amended protocol is fine with the FDA. Second, ensure that we can finance one way or another, either through a partnership or other financial means, support at the beginning of the trial. And we will certainly get back to you as soon as we have a final decision made when it comes to that.
spk00: That's great. Just also a couple other questions. I was just wondering if there were any synergies with RECOBI and TRIGARZO based on what was seen at the CROH conference this year?
spk07: Yeah, what we present, like at the moment, what we have shown in our pivotal trial in the 40 patients, we had a combination of Ibenzumab and Rucobia. And even if those are the two only fully active agents, we can control the viral load. It becomes undetectable. and we see that that combination is more and more used on the market. We also work with scientists that are assessing the synergy or additive effect of different drug in vitro models, and those data will be presented most likely later this year. At the moment, what I can say is that with Recobia, we see additive effect, which is very, very good.
spk00: Okay, and just one last one here. There was an independent Italian study last year showing that VAT levels predicted COVID ICU admission. And just wondering if there are any studies looking at a grifter for this, and is there any law of label use going on for grifting this indication? Thanks.
spk07: Christian? Yeah, this is a very good question, and this was a very nice observation. And there's the Italian study, but there were other also U.S. studies looking at making the link between the significant amount of fat and more severe symptoms of COVID. And what we've done, it's really showing that that is not only cosmetic. It needs to be treated and physician need to tackle that. And what we did, the medical team was able to talk to the CLIL about these data. These data were very well received. It was also included in our speaker program and the physician in our speaker program were able to talk about this. Then that's something which is important. And it shows that for us, it's in the HIV patient population. but that VAT should be treated and making sure that it is reduced to maximum.
spk02: Thank you, Kirsten. It further reinforces the fact that VAT or lyquid dystrophy is a serious medical condition, so we're using the bulk of evidence in continuing medical education, and we think that more and more doctors will see for themselves that we are the only solution to treat lyquid dystrophy in HIV patients.
spk00: Okay, that's great. Thanks very much.
spk01: Enjoy. Thank you. And our next question comes from the line of Andrew Leno with National Bank. Hi, good morning. Thanks for taking my questions.
spk05: A few for me, but I'll start with the first one for Paul, perhaps. The question is, on the sales force, what is the rationale for internalizing the sales force, and what do you plan to achieve that you are not achieving through the CSO?
spk02: Well, anyone in the in business will tell you that contract sales organizations are fine, but normally you use a contract sales force for only a period of time, either before you transition to something else or because you have a new indication and you want to have a surge that is not permanent in the type of activities that you want to have for the long run. Our rationale was if we want to beat the competition, if we want to be relevant, we want to actually produce the type of growth that we want to set for ourselves, we need to have a very engaged, very competent, very relevant field force. And I think that we wanted to see if we could move these products before initiating the transition because this is a significant endeavor. And as I highlighted in this speech, we were extremely pleased with the results we got in terms of new prescriptions, new enrollments in the latter part of the year last year, as soon as we could execute on our strategies and tactics when it comes down to, you know, interacting face-to-face with physicians. So to me, that was a trigger. And what we foresee is more effectiveness, field force effectiveness, more synergy with the medical community, feel a team, and all of that together will actually, I think, trigger superior engagement and superior results. John, do you want to add a few things?
spk03: Yeah, I mean, as with any product, I mean, having a highly engaged sales force is absolutely critical, and, you know, with a contract sales force, I think there's some inherent limitations. One, we had a fairly high turnover rate, and due to the nature of these, you know, the contracts could be somewhat transitory, and You know, having our own people is going to be a significant benefit to these products. You know, we also hired a VP of sales last year that has significant experience in HIV. So we're in the process of building the capabilities of the sales force, and we think it's going to really pay big dividends in the coming months.
spk05: Okay, no, great. That is a great comment. And one more follow-up on that. What would be the cost bump initially, and what kind of ROI are you targeting in the timelines, you think? if you can, to achieve that ROI with the internalized sales force.
spk04: Thanks, Andrew. Well, the cost is pretty much cost neutral because we did pay a hefty management fee to Cineos to manage our operations, so we're no longer paying that. We do have to hire some more support staff. But the cost in general is neutral. It really is for the engagement, the lower turnover, and the recruitment of top reformers. So on a cost basis, it's pretty neutral, but it's really on the operations where the impact is best seen.
spk05: Great. Thank you very much for that. Nick? Question I have on Trogarzo. First, if you can quantify what the flowback provision in Trogarzo was this quarter, just more for modeling purposes. And the other question on Trogarzo is if you can give an update where it has gained reimbursement in Europe and what other countries are you targeting there?
spk02: Well, the situation in Europe is one country at a time, as you know. We got an indication for being able to commercialize from EMA a while ago. But the negotiation is country by country. We've got some countries now where we have been able to negotiate a good price and no cap when it comes down to a total number of patients we can recruit. There are some other countries where we have a good price, but we do have a cap. And there are some other countries in Europe, as you may imagine, where there's a direct relationship between pricing and volume. And for those, we are extremely... careful before accepting an offering that would not allow us to actually promote for the long run based on the fact that we would not be able to reap the benefits of our investments. So we are negotiating with many countries. All the countries in Europe for which we have approvals are in scope. Incidentally, we just negotiated a good price in Israel recently. And we will continue in smaller countries like Austria and and like Norway, but the main countries for us in Europe is probably France. We find that there's a significant potential in Italy where we secured a price earlier, you know, last year at the end of 2021. And we also have a great deal of expectation for a country like Portugal that is a small country, but that carries a fair amount of HIV-1 patients. Spain is in scope, UK is in scope, and it's one country at a time, as I said, based on their way of negotiating. So we have to be customer-facing, customer-focused, and it's one country at a time. And we'll let you know where it pans out in the end. But to answer your questions, all the countries are in scope. We just need to do the right negotiation and get out of the negotiation in a way where we could actually have a go at to market model that makes sense for us. Now, I think your second question had to do with Tragarso and the potential clawback. Is that what I heard?
spk04: Andrew, we're not announcing the exact size of the provision. We're still in negotiation with the French government, so we want to keep that private for now. But what I can say is that we would have shown growth on the top line overall. or the quarter if we hadn't had it. So that's all we're going to say right now.
spk05: No, that's good, Carlo. That's good, Carlo. Thank you. And just a couple of quick ones for me on the development products, and I'll turn over the line. But on the NASH, the modified protocol, is this in response to any feedback you've received during discussions with potential partners, or is it an internally developed strategy?
spk02: Well, you know, it's twofold, I guess. You know, we've been doing a fair bit of analysis to compare the benefits of doing a Phase 2B and then a Phase 3 trial. And quite frankly, a Phase 2B trial would be very similar to, you know, doing this interim analysis that we want to embed in our Phase 3 protocols. So we believe that we are good to go, and the agency believed that a long time ago because they gave us, you know, a study in the proceed letter. But at the same time, chopping off the study in smaller bits from the financial point of view makes a great deal of sense. And being able to have a hard endpoint analysis after the first 350 patients are treated makes also a lot of sense from both a science and a financing point of view. So, you know, we think that providing that the agency is fine with this approach, which is called seamless type of approach or protocol, I think we are going to have, you know, all the cards on the table for us to make a final decision. Christian, do you want to add to this? No, I think that's
spk05: Great, thank you. And last one for me, on the oncology, the TH1902, the outlining in China, how imminent is this as a strategy? Would you do it if you had something on the table at this point, or would you wait until you have established the MCD and have some indication of activity from the PASCA trials?
spk02: Well, thanks for the question. I'll let Philippe answer that question. We are in negotiation with many companies. Some of them are very happy with what they've seen, and already we have terms. Some others, it may actually turn to we want to see more. Philippe, what can we say?
spk04: I think the overall objective here was to get a Chinese partner, because we're not going to develop it ourselves for the Chinese market. So we wanted someone to get involved as early as possible, have as much as possible a parallel development track. And so, you know, obviously, we contacted probably 100 companies, and some of them said, you know, we'd rather wait for phase one data. But some of them, you know, are willing to take the risk. So we don't see why we should wait, because there will be milestones associated to every regulatory and development process. hurdle that we go through. So really what we wanted to achieve was have someone as early as possible in the development so that they could help us bring the product forward on a global basis.
spk02: So in short, this is a value-generating strategy that we want to put forward.
spk05: That's great, Collar. Thank you very much.
spk02: Thanks for your question.
spk01: Thank you. And I'm showing no further questions.
spk04: Okay, so we'll take a few questions from the web platform and there's quite a few on oncology trial in terms of the selection of the new cancers that we'll be putting into the Phase 1B trial. So I'll read and paraphrase a few of them. So can you please clarify the Phase 1B cancer types and what informed the decision to add more types and to drop pancreatic and colorectal? And was it something that was seen in the trial or other work that you did?
spk02: Well, thank you for the question. This is an important announcement that we've made today, and I wouldn't like anybody to actually see this as a drop of colorectal or pancreatic. You should see it the other way around. What we've done is that we are optimizing our basket trial to see early sign of efficacy based on the sort one work that we've done to measure the expression of that receptor. Christian, do you want to say more?
spk07: If you remember, the protocol was submitted to the FDA and completed a bit more than a year and a half ago. But since then, we've done many, many analysis on different tumor types. And what we have seen is that that sort of receptor is significantly expressed in a large number of patients in all of the cancers that we've selected for the PACE-1. And as Paul said, It's a better chance to see signs of efficacy, but it's also a better chance to have a fast track to the FDA without the diagnostic test. And that's the goal at the moment. And maybe just for colorectal cancer or pancreatic cancer, we've seen some expression, but it's only in a lower percentage of patients. Eventually, with the diagnostic test, that could work as well. But the initial goal is fast to market in the cancer type that we're expressing the most in this
spk02: So this is a very important point in today's conversation. We are just, you know, highlighting some or integrating some new learnings into our protocol so that we increase our chance of winning and driving an indication as fast as possible.
spk04: And maybe just to close on that, we are planning to either publish or present the results from the sortling work that we've been doing. So do you expect the KH1902 IND to be for all SORP1 overexpressing solid tumors, or will it be a phase two, phase three for each cancer type?
spk07: This is a very good question. It all depends on what we see in our basket trial. At the moment, most drugs are developed tumor type by tumor type. If we see more efficacy in one tumor type, we might use that approach because it will be faster to market. If we see similar efficacy in many different tumors, there could be kind of a basket approach as well. But I think that it will most likely be a one-type cancer for the fast track.
spk04: Okay. On Th1902 again, how serious were the adverse events in cycles after the initial cycle?
spk07: Yeah, what we've seen is our adverse events are linked to when you give higher dose of docetaxel. At some point, you cannot reach or go higher to a certain level. And what you see with docetaxel, we've seen the same after two, three cycles. That would be signs of neurotoxicity. That's seen with docetaxel. We've seen also some signs of visual acuity, seen with docetaxel, and some fatigue. Then we have a regular discussion with all of the investigators taking part in this study, and based on that observation, we decided to go to the 300-metagrav per meter square, where we think that even if it's at 1.5 times the dose of docetaxel, it will be much better tolerated and we'll be able to give way more cycle at the 300-metagrav per meter square, which is the objective in treating advanced cancer patients.
spk04: Question here, will you be looking at other applications for the SORT1 receptor outside of oncology?
spk02: So thanks for the question. We know that there could be some other applications based on SORT1 expressions in other parts of the body, but quite frankly, we've got our hands full now with SORT1 expression in oncology and its potential. You also heard that some companies have shown interest in our peptide as a carrier for to get to the cancer cells, and we'll have to do a fair bit of education on the SORT1 receptor as we get into the basket trial so that people can understand how it works and why we have identified this entry to the cancer cells while the vast majority of companies have not. So we've got to be very, very prudent here in the way that we spread ourselves, and there are many additional applications outside of cancer, but this is not part of our you know, journey at this time.
spk04: Okay. How long will it take to confirm safety at the 300 milligram level if you give a timeline?
spk07: The way the protocol is set is what we recruit three patients. We need to hold them for three weeks and there's no DLT. We go to the next three patients, hold them for three weeks after we'll be ready for the basket trial. I think the one thing that we have to be careful in terms of timeline, sometimes We have a patient who's almost ready to start, and there's a significant progression of the condition, and the patient has to be excluded from the trial. Then there could be a bit more time in recruiting the patients, but I think within the next two to three months, we should be able to confirm that we're moving ahead with the basket trial.
spk02: I want people to understand, thank you, Christian, that the dose escalation, unfortunately, is not always a straight line. And it could mean sometimes that you go one step forward to have one step backward. And it looks like now we are really at the end of this process, so we need to confirm what just Christian highlighted in the next couple of weeks. And as soon as that confirmation is done, we'll actually start opening up at a different pace towards the basket trial.
spk04: Last question on oncology. Any upcoming conference presentations on cancer? I'm going to answer that. We can't really answer, but we'll tell you that AACR is coming up and ASCO is coming up in June as well. That's all we can say on that for now. There's a question on the estimated cost of pursuing the first 350 patients in NASH, and we're still working with our CRO on determining the exact cost, but it should be in the $50 million range, so about a third of the overall cost for a third of the patients. And there's a question on the impact, again, on the cost impact on the Salesforce transition. As we said, there are a little bit of some upfront costs to set it up, but on a go-forward basis, it should be cost neutral. So that concludes the Q&A session, so I'll hand it back over to Paul for closing remarks.
spk02: Well, thank you to everyone who joined our call today. we hope that we have clearly articulated the four main drivers of Thorough Technology's 2022 Strategic Operating Plan. Our marching orders are rather clear and focused on these drivers, which includes, firstly, the rollout of our newly established internal sales and medical field force in support of our franchise activities. We believe our internal field force will allow the company to be even more competitive in 2022 and beyond, as reflects our superior ability to connect and engage with patients and providers in order to improve therapeutic outcomes. Second, from a financial metric perspective, it is our intent to build upon the momentum of the second half of fiscal 2021 and are targeting from 13% to 20% growth in our commercial portfolio now that face-to-face activities have mostly resumed. The continued commercial success of our brand is a strategic imperative and at the core of maintaining a fundamentally strong balance sheet, as well as working capital to fund activities. Third, we will continue to advance development of our oncology pipeline and the development of TH1902 for the treatment of solid, metastatic, and refractory cancers. In tandem to this R&D effort, we are exploring out-licensing developments for TH1902 in Greater China, in addition to partnership with other pharma and biotech companies who are interested in our peptide as a carrier to target cancer cells through SORT1 receptors. Lastly, we will continue to advance our Phase 3 NASH program. Partnering discussions around NASH carried over from 2021 are also continuing while we seek non-diluted financing options for the program. Having filed an amended protocol with the FDA, we are moving the program forward, which will carry a significantly de-risked development profile by assessing the efficacy of tesamorelin on a much smaller subset of patients. I would like to reiterate that we believe these driving forces will allow the companies to be even more competitive in 2022, and unlike a majority of early-stage biopharmaceutical companies, biotechnology's commercial business vastly differentiates ourselves. as we continue to work on our development pipeline of late and early-stage assets spread across several indications. And with this, thank you, everyone, for joining our fiscal review of the period. We look forward to the next set of quarterly financial and milestone updates as our story progresses. Have a great day, everyone.
spk01: This concludes today's conference call. Thank you for participating, and you may now disconnect.
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