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spk00: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Terra Technologies' first quarter fiscal year 2022 earnings conference call. At this time, all participants are in listen-only mode. Following the presentation, we will conduct a question and answer session with analyst instructions will be provided at that time for you to queue up for questions. Following the analyst Q&A session, investor wishing to submit a question may do so by clicking on the ask a question link on the website 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, Wednesday, April 13, 2022, at 8.30 a.m. Eastern Time. I will now turn the call over to John Mullally, LifeSite Advisors. Mr. Mullally, please go ahead.
spk01: Thank you and welcome. Mr. Paul Levesque, President and Chief Executive Officer of Thera Technologies, and Mr. Philippe Levesque, Senior Vice President and Chief Financial Officer, will be the speakers on today's call. Additionally, Thera Technologies has also asked Christiane Marciolet, Chief Medical Officer, to participate on today's call to provide an update in regard to the progress of TH-1902, the company's lead oncology asset. Now, before Paul begins his remarks, I have been asked by Thera Technologies to read the following messages regarding forward-looking statements. I would like to remind everyone that Thera Technologies remarks today contain forward-looking statements about its current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or other future events 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. Thera Technologies refers current and potential investors to the forward-looking information section in its management discussion and analysis issued this morning available on CDER at www.sedar.com or on EGAR at www.sec.gov. Forward-looking statements represent Thera Technologies' expectations as of April 12, 2022. Except this may be required by securities laws, Thera Technologies does not undertake any obligation to update any forward-looking statement, whether a result of new information, future events, or otherwise. I would now like to turn the conference call over to Paul.
spk05: Thanks, John, and good morning to everyone joining the call today. We are well into the new reporting year and off to a great and solid start. As you can tell from our excitement during the year-end call, we have never been more confident in our recent history than where we are today, fully leaning into the advantages of our strategic business model consisting of both a development pipeline, and a commercial drug business. On this note, we have asked Christian Marsolet, Ferrotechnology's chief medical officer, to join our call today. In order to provide a brief but important update on the significance of the new preclinical TH-1902 studies as presented at this year's American Association for Cancer Research annual meeting, which took place earlier this week. Our pipeline across oncology, where we are exploring a heavily peptide drug conjugate asset, is potentially a promising new technology representing a broad range of commercial opportunities across solid, refractory, and metastatic cancers for patients with significant unmet needs. Our Phase I study investigating Th1902, our lead peptide drug conjugate linked to docetaxel, a well-established and well-characterized cytotoxic agent used in the treatment of cancer, has been progressing well in the past few weeks. Currently, we have completed the 300 mg per square meter dosing regimen, equivalent to 1.5 times the indicated therapeutic dose of docetaxel alone for three patients with TH1902, and are nearing the conclusion of this stage of the trial and establishing the recommended phase two dose. We expect to have all six patients of disarm and roll by the end of April. This is significant as the targeted delivery of TH-1902 along with the rapid internalization of the drug in cancer cells could enable the accumulation of 7.5 to 10 times more psychotoxic agent within cancer cells as compared to the administration of docetaxel alone. This increased tumor penetration significantly and specifically in cancer cells is a key differentiator of TH92 as a therapeutic treatment for cancers. Now, if the absence of dose-limiting toxicity, or DLT, is confirmed at 300 mg per square meter, this dose will become the recommended Phase II dose. As previously discussed, once the recommended Phase II dose is established, Initiation of enrollment of the larger open-label basket trial will begin immediately, which can potentially start as early as the end of May. The basket trial will further assess the safety and durability of TH-1902. In addition, we are confident in the design of the basket trial as it should enable us to show preliminary efficacy in a number of solid tumors in the second half of 2022, given that we have selected cancer types where sortalin expression is high. An amendment to the Phase I protocol was submitted to the FDA to include the following solid tumor types, hormone-positive breast cancer, triple-negative breast cancer, ovarian cancer, endometrial cancer, melanoma, 10 patients per arm was submitted. One additional arm will be added to include thyroid, small cell lung, prostate, and potential other high-sorted and expressing cancers for 15 patients in total for that arm. We're happy to report that to date the company has received and responded to questions raised by the FDA and does not expect to receive any additional questions before the April 15th deadline date by which the amendments to the protocol will be deemed accepted and ready to be implemented. On the partnering front, out-licensing development and commercialization rights for TH-1902 in Greater China continues. and are ongoing with a number of different pharmaceutical and biotech companies. The early signs of TH-1902's efficacy expected in the second half of 2022 will aid in further supporting conversations around the commercial evaluation of TH-1902's development rights. Earlier this week, the company presented the three posters at the recently attended AACR annual meeting, including new in vivo TH1902 preclinical data demonstrating tumor growth inhibition of human cancer stem-like cells, CD133 positive, in both triple negative breast and ovarian cancers. Cancer stem-like cells have significant implications in the carcinogenesis of cancers and an important area of investigation. And therefore, I've asked Christian to provide additional color to what was presented, considering the importance and implications of the data. Moving on to IGRIFTA-SV now. We previously noted our intention to file a supplemental VLA for the FH formulation for Tesamorlin by the end of the first quarter of calendar 2022. However, we were recently informed by the sole global supplier of bacteriostatic water for injection or BWFI, which is required for the reconstitution of the company's F8 formulation, that its manufacturing facility was recently inspected by the FDA and is now required to make modifications before resuming manufacturing and shipment of its BWFI product. The FDA also put out a bulletin noting the shortage of BWFI that is available to the market. As a result of this supply chain interruptions, we have decided to pause all external activities related to the company's Phase III NASH trial and delay submission of our F8 formulations SDLA. As you may be aware, the Phase III NASH trial was underpinned by the use of the company's F8 Tessam Orleans formulation. With the manufacturing overhang around BWFI We can no longer reliably comment with certainty as to when we can resume lifecycle management and start the Tessam Orleans Phase 3 activities as we seek to source BWFI. On a positive note, we learned that initial shipments of BWFI are scheduled for high-priority customers, including hospitals, clinics, and pharmacies, which may indicate that the situation is on track to get normalized. So as to not confer any confusion, we want to note that there is no shortage for water projection or WFI, which is a different diluent used in the reconstitution of our technology's currently marketed F4 formulation. Although this unplanned circumstance is unfortunate, we're still awaiting feedback from the FDA on our protocol amendment and will be And we'll continue to refine our national development plan by working towards identifying an ideal partner, reviewing alternative financing that can take the program through its interim analysis, and determining that we have a competitive method of administration for when we commercialize the product. Beyond our pipeline efforts, we are very proud of our commercial business, which reported sales of $70 million in fiscal 2021, for which we have great aspirations for in the future. And to this effect, before we go further with today's call, we want to reiterate guidance, expecting fiscal year 2022 revenue to be in the range of 79 million and 84 million for full fiscal 2022. This represents growth of the commercial portfolio in the range of 13 and 20% when compared to 2021. We are emphasizing 2022 outlook supported by the fact that we continue to experience solid sales growth through advancement of our 2022 operating plans in spite of Q1 being historically our weakest quarter. With the GRIPSA SV commercial sales achieving 35% growth and overall blended commercial sales growing into double digits by 20% this early on in the fiscal year, The full onboarding of the newly hired internal commercial field force will only serve to reinforce our sales objectives. As we continue to exit pandemic restrictions, it is our expectation that we will be able to deploy the full breadth of our field force, enabling increased physicians' engagement once fully onboarded, which should be the case by the end of April. As this is now an internal function, we expect employee engagement to increase, turnover to diminish, and allow for the recruitment of top-tier talents in the future. Against this backdrop of continued performance, we're even more convinced that the building of our internal field force at this particular juncture was the right call. For Travarzo, a supplemental biologics license application, so an S-DLA, was filed with the U.S. Food and Drug Administration, the FDA, at the end of 2021 for the company's ID push mode of administration for the treatment of HIV-1. With the FDA accepting our filing, we were given a target action date of October 3, 2022, in accordance with the Prescription Drug User Fee Act, which is commonly known as a drug's pedophilic. There are technologies in time that are also evaluating an intramuscular mode of administration for trigarzo within the TMB-302 study. The IM formulation, if approved, will be a marked improvement in the patient experience. So, in the next few months, well before the start of the summer season, You should be expecting two significant milestones. The first is the initiation of Part B of the Phase 1 trial of TH-1902, or what we refer to as the basket trial. The second is the full launch of our company's sales force in support of our year-end sales objective. Now, before I turn the call over to Philippe, who will provide a financial summary of the reporting period, before moving to Q&A, I would like to introduce our chief medical officer to discuss the TH-1902 preclinical data that was presented at AACR this year. Christian?
spk03: Thank you, Paul. Hello and good morning, everyone. Terra Technologies attended the AACR 2022 annual meeting, and we wanted to share with you some of the findings of the three posters that were presented. It is our belief that the SORT1 receptor is an ideal candidate for trafficking peptide drug conjugates, or PBC, specifically into cancer cells. As background, short-tinted receptor expression is both common and high across many known tumor types, but almost absent in LT tissues, making it an attractive target for cancer drug development. Short-tinted expression, interestingly, also increases as a function of tumor grade, 1 to 4, and is typically associated with poor prognosis and decreased survival rates in a number of cancers. Our SORT1 positive technology is an oncology platform consisting of novel peptides targeting the SORT1 receptor. We are currently investigating the exploitation of the SORT1 function with various combinations of PBCs, which lead to receptor-mediated trafficking of well-established anti-cancer agents. For example, docetaxel, doxorubicin, and SN38 that are attached to the novel proprietary peptide. This approach could potentially decrease the off-target of anti-cancer drugs, like cytotoxic, and increase their efficacy by increasing their concentration specifically in cancer cells. A key aspect of this technology is the ability to traffic payloads directly into cancer cells, where the active PDC payload is released from the peptide to exert its cytotoxic effect specifically inside the cancer cell, sparing normal cells from toxicity. This is accomplished by the exploitation of the source in the receptor native function as a transmembrane scavenger receptor involved in the import-export of large peptides into the cell via the endosomal lysosomal pathway, a cellular shuttle system. The platform technology allows for versatile and flexible conjugation strategies in order to achieve different ratios of anti-cancer drugs to peptide. These exciting new clinical data presented at AACR demonstrate the significant potential in preclinical studies of our platform technology as a treatment for short-term expressing cancers. Additionally, the promise of their technology short-term positive technology platform suggests that it can be effective in targeting and trafficking different anti-cancer payloads. As part of our preclinical studies, we investigated cancer stem-like cells In humans, cancers themselves are an important target in treatment of cancer as they contribute to the carcinogenesis of cancer and are typically resistant to conventional treatments such as chemotherapy and radiotherapy. Moreover, SORT1 is also indicated in the formation of pescalogenic mimicry structures known to feed the tumor as they grow and are also associated with cancer resistance to standard treatments. From the human cancer stem-like cell study, bearing the CD133, a known cancer stem cell marker, we demonstrated that Th19O2 peptide conjugate moves into those tumor cells via the SORT1 receptor native function. Additionally, once inside of the tumor, Th1902 induces cell death of these cancer stem-like cells more effectively than the cytotoxic agent alone in both triple negative breast and ovarian cancers. These results are very impressive as cancer stem cells are known to be resistant to most anti-cancer treatment. In a second poster, we have presented the results of the combination of Th1902 with carboplatin as compared to eclitexel or docetexel carboplatin combinations in ovarian cancer. The results clearly demonstrated that TH1902 alone is better than some of the gold standard treatment for ovarian cancer, and that the combination of TH1902 and carboplatin can further improve the efficacy of ovarian cancer treatment. This is the first time we showed that Th19O2 can be used in a combination treatment. These results certainly opened the door for treating patients in earlier lines of cancer treatment. Our third poster presented results showing Th19O2 demonstrated better and sustained efficacy at doses equivalent to the maximum tolerated dose of docetaxel in human and urine melanoma subcutaneous xenograft models. and that the mice prolonged survival rate increased 263% in mice treated with TH1902. We were also able to demonstrate that TH1902 inhibited the formation of lung metastasis in the B16F10 model across different TH1902 regimens. These insightful new results further confirmed that our SORT1 passive technologies is a novel therapeutic approach to delivery of established anti-cancer drugs to tumor cells, thereby optimizing efficacy, limiting toxicity, and improving the therapeutic window of the cytotoxic agent. It also shows that this platform could be effective in some resistant cancer, as well as against the development of metastasis. To summarize, The data that was presented at AACR is part of the key differentiators of noble Th1902. First, in clinical work, we have observed enhanced effectiveness of Th1902 versus docetaxel alone, especially in hard-to-treat refractory cancer. Second, the capacity of Th1902 to inhibit formation of BM and growth of cancer stem-like cells can in fact be the mechanism of action at play behind those observations. And lastly, leveraging SORT1 receptor could allow Th19O2 to target cancer cells with a 7.5 to 10-fold concentration of the cytotoxic agent in the cancer cells while sparing normal cells, as those are known to show little or no SORT1 expression. Thank you for your time everyone. I will now pass the call to Philip, Terra Technology Chief Financial Officer.
spk04: Thank you for reviewing the data that we presented this week at AACR and good morning everyone. So I'll go through the financials before I turn the call over to the operator for the Q&A session. Consolidated revenues for the three-month period ended February 28, 2022, was $18.6 million compared to $15.4 million for the same year-ago period, representing an increase of 20%. For the first quarter of fiscal 2022, net sales of Ingrifta SV reached $11.7 million compared to $8.7 million in Q1 of last year, representing an increase of 35%. due to the combined effect of a higher number of units sold and a higher net selling price. In the first quarter of fiscal 22, Travarso net sales amounted to $6.9 million compared to $6.7 million last year, representing an increase of 1.6%. While unit sales were higher in both North America and Europe, revenue growth was impacted by greater rebates, mostly in Europe. In Q1 2022, cost of goods sold was $4.9 million compared to $4.2 million for the same quarter last year. The increase in cost of goods sold was mainly due to higher sales. A cost of sales also includes amortization of $1.2 million related to the repurchase of the GRISTA commercialization rights. This figure is the same as it was in Q1 2021. R&D expenses amounted to $8 million for the three-month period ended February 28, 2022, compared to $4.9 million for the same year-ago period. This increase was largely due to the higher spending in our oncology programs, increased spending in medical and patient education, as well as increased medical affairs spending in Europe. Selling expenses amounted to $7.8 million for Q122, compared to 6.2 million for the same period last year, reflecting the addition of key hires in North America and Europe, as well as greater commercialization activities in both territories. The amortization of the intangible asset value for the IGRIFTA and TRIGARZO commercialization rights is also included in selling and market development expenses. As such, we recorded an expense of $785,000 in Q2 as well as in Q1 of last year. G&A expenses amounted to $4.4 million for the first quarter compared to $3.5 million for the first quarter of last year. The increase in G&A expenses was mainly associated with an overall increase in business activities and increased activity in Europe. Net finance costs for Q1 2022 were stable at $1.3 million. Net finance costs in the first quarter of 2022 and 2021 included interest of $802,000 on the senior convertible notes issued in June 2018. Net finance costs also include accretion expense of $517,000 in the first quarter of 22 compared to 581,000 in a comparable period in 2021. Given the above increase in revenues and greater expenses, a greater increase in expense for the three-month period ended February 28, 2022. Net loss for the period was 9 million compared to 5.9 million for the same period last year. In the first quarter of 2022, operating activities used $4.1 million as compared to $1.9 million in the comparable period of fiscal 2021, primarily due to the increased loss in 2022. In Q1 2022, changes in operating assets and liabilities had a positive impact on cash flow of $69,000 versus a negative impact of $3.3 million in Q1 of last year. This year's changes included a negative impact from higher accounts receivable and from a decrease in accounts payable. And these were offset by positive impacts of lower inventories and lower prepaid expenses and deposits. So we ended the first quarter of fiscal 2022 with $34.3 million in cash, bonds, and money market funds. The second quarter of 2022 is off to a good start, and as Paul just mentioned, we're pleased to confirm the guidance for fiscal 22, expecting revenues between $79 and $84 million. So with that, Paul will come back with final comments, but first, we'll open the call to take your questions. Operator? Operator?
spk00: Thank you. Ladies and gentlemen, if you'd like to ask a question at this time, you will need to press the start and the one key on your touch-down telephone. Please stand by while we compile the Q&A roster. First question coming from the line of Andre Uddin with Mackey Research Capital. Your line is open.
spk06: Thank you, operator. Good morning, Paul, Philippe, and Christian. Just looking at Europe right now, where is your main commercial focus? in terms of countries, and also how many reps do you have there, and sort of what are your plans for those smaller European countries? Thank you.
spk05: Well, thank you for the question. So as you know, in Europe, not much can happen before you obtain pricing and reimbursement. That is an endeavor that is a country-by-country endeavor. We've been in discussion with many jurisdictions. We have been able to establish a fairly good price in many small European countries. But in the major countries, aside from Italy, where we negotiated what we believe is an acceptable price, were still in negotiation. And we had to reject the offering from the German government because we could not accept the price that they wanted, you know, to put forward for a drug that we consider, you know, very, very, very innovative medicine and what they were offering would not match that positioning. But it's a country-by-country negotiation. We're currently in the midst of the negotiation in France Things are evolving. We believe that it's going to slow down as France is going through the first round and second round of their election process. So April will probably not be decisive. But France is an important country for us because the pool of patients is significant. So we will be updating the market as the story is unfolding. And meanwhile, we have resources in Europe that are very important for global activities and for the preparation of our clinical programs in oncology. So we have a presence in Europe. We're committed to continuing having a presence in Europe, and we're trying to do our best at this time to pull the pricing, you know, that is matching the innovative nature of Travarza.
spk06: Okay, that's useful. You presented some nice preclinical data of TH1902 at EACR. I just was wondering if it's possible if we're going to see any data at OSCO in June. Thank you.
spk03: Christian? I know, Andre. Thanks for the question. Andre, as we move forward with the first inhuman at the moment, as it was mentioned, we have three patients that received the 300th. We need to go to the following three patients at 300th. And the ASCO is in June, and the deadline for submission of the abstract were earlier on this year. Then we won't have any communication at ASCO, but we're hoping, as Paul mentioned, that towards the end of this year that we should have an update on the potential activity of the drug in patients.
spk06: Okay, that's great. Thank you.
spk05: Thanks for your question. Obviously, the reason why we're putting emphasis on what was just presented in New Orleans this week is is because we believe that this is very, very significant. This is preclinical data, but it provides reassurance for its mechanism of action. And we find it extremely innovative. And as we move forward with the basket trial, we'll see what is at play. But I think that what Christian presented today is absolutely exciting. Next question.
spk00: And our next question coming from Delana of Stephen Kwan with National Bank. Your line is open.
spk02: Hey, guys. Good morning. Thanks for taking my question. I'm just calling in for Andrew. And actually, most of my questions have been answered between the last questions and the opening remarks. I just had one. So given there have been some shutdowns in China, is this at all impacting your negotiations and partnership strategy? Thanks. No, it is not.
spk05: It's ongoing, and quite frankly, you know how negotiation goes, is that you have a set of companies that are moving faster than others. You don't want to conclude too fast before you let other companies come in. So we have a nice, I would say, crew of or mix of biotechs and large pharma that are showing interest. And quite frankly, as we get closer to early sign of efficacy, and we keep saying that this is what we're going to see soon, or as soon as early on into the basket trial, I think the interest is going to increase. So quite frankly, getting the conversation going, getting under CDA with, you know, many of them will actually be conducive to getting the right partner and the right valuation for this great asset for greater China. Things are moving. As per the plan, when it comes to that, do you want to add anything?
spk04: Well, no, but the only thing is that we haven't really been getting the feeling from pharmaceutical or biotech companies in China that there's nothing more than business as usual. So there hasn't really been any impediments to talking to them or anything. It's business as usual for them.
spk02: Okay, great. Yeah, thanks. That's all my questions.
spk04: Okay, so we have some questions from the webcast. So this is a question for Christina. What elements from the in vivo and in vitro research you have seen in humans thus far that would lead you to believe that scientific view of the concept around sorrelin as a target, its function, and how is that playing out in a manner consistent with your previous discoveries?
spk03: Thank you for the question. It's a bit premature to talk about the human data, but in terms of what we've seen in vitro and in vivo, it's always very impressive. It's always very consistent. We have very similar efficacy using cell lines that are expressing the sorts in receptor. And what we see is really a significant increase of the concentration of the cytotoxic inside the cancer cell, versus the normal cells. And doses that are similar to the dose used with docetaxel in human, the safety profile is very good. And maybe like in terms of efficacy, it's early, but for safety, what we have seen thus far in human is more or less similar than what we were expecting based on the animal study. 420, as we mentioned, we've seen some toxicity, which is normal because this is about two times the dose of docetaxel. And that's the reason why now we have decreased to 300. There's a number of patients that received 300, and recently three patients where we haven't seen any DLT in the first cycle. And I would like to remind you that 300 milligrams per meter square of TH1902 is the equivalent to 1.5 times the dose of docetaxel, and we don't see DLT. And that's something impressive. In addition, based on what we have seen in the animal, we have shown before that the concentration of docetaxel in the cancer cells when administered with GH19O2 is four or five times higher. Therefore, if we can give 1.5 times the dose of docetaxel, the ratio or the accumulation of the cytotoxic inside the cancer cell should be between 7.5 and 10 times. And the program is moving well. We're expecting good results in the near future.
spk04: The next question regarding TH-1902, is there a window of opportunity for revenue from TH-1902 that may come with any accelerated approval available with the received fast track designation?
spk05: Thank you for the question. This is a good question and an interesting one. Let me try to address it with an activity that we conducted recently that was really, really productive. We orchestrated an oncology strategic session, and we had a few individuals within the company that attended, and we had Mace Ruffenberg, our advisor. We had Dr. Biddy Vo, that knows obviously the platform extremely well. And we had Joe Arena, our scientific board member. And we reviewed all the data. We reviewed where we are with TH1902, and we reviewed... the place that TH-1902 can play within the arsenal and the treatment guidelines are different indications where we know this sort of expression is high. And quite frankly, what we want to do is exactly what your question is about, which is can we actually, as soon as we see compelling results, early sign of efficacy for one of these arms, can we turn to the agency with this fast track designation and say, Can we design a larger trial so that it could become the pivotal trial to an indication? That is not obviously a done deal. It's not something that we can forcefully predict at this time, but this is the plan. The plan will be to actually accelerate at least one indication the fastest possible way and keep developing applications afterwards. Because what you have to understand is that treatment guidelines in oncology rules, and we need to squeeze in somewhere in the treatment guidelines related to cancer therapy for one indication or two indications, but it's one tumor type at a time. Do you want to provide additional color on this?
spk03: Well, that's the plan so far. And again, there are many examples in recent years where drugs were approved with a limited number of patients through the accelerated path with the FDA. Again, if we see signs of efficacy in some of those solid tumors, we will meet with the FDA and we will try to obtain a design with a limited number of patients to get to the market as fast as possible.
spk04: There's a few questions on just a clarification around where exactly we are in the enrollment of the six patients at the 300 milligram dose.
spk03: Can you just maybe clarify where we are exactly and when we expect that sixth patient to be in? So far, as was mentioned before, there are three patients now that were treated at 300. Once we lowered the dose after the treatment at 420, We did not observe any DLT within the first cycle. The other patients are being screened, and we do think that those three patients will be treated in April. As you know, it's sometimes difficult because the patients are advanced, but we do think that those three patients will be treated in April. Then three weeks after that, the cycle will be completed, and if there are no DLT, and based on the experience that we have with the drugs so far, We're confident that there should not be any DLT at 300. We will be ready to initiate the basket trail, which should be towards the end of May then. Hope this clarified the question.
spk04: Another question, can you please clarify whether you're planning for the NASH program to progress or how you are planning for the NASH program to progress?
spk05: So let me summarize the elements here, but I think I touched on this in the speech today. We're still awaiting some feedback from the agency when it comes down to the amended protocol that we presented. So as you would recall, we want to have a formal interim analysis on hardpoint data. And this amendment was submitted, and within the next few weeks, we should have the feedback from the agencies. we said that we wanted to continue with partnerships. So we are also, you know, in conversation with different companies on partnership, and we're looking in parallel at, you know, how we could finance this in a non-dilutive way so that we can, you know, start and execute the front part of that trial all the way to the interim analysis. We also need to start that trial with the F8 formulation. That is a prerequisite. We never wanted to carry on that trial with the F4. And you will recall that when we started our plan, we said that there were three things that were extremely important for us to aspire to getting a decent market share once the market will be constituted in years to come. First one was to have the right IP protection, and in this case, the IP protection is linked to two things. It's linked to the FH formulations IP that we have in Europe and in North America, but also the use patent that we have linking the use of Tessamore and Nash and NAFL. So that's important, and that doesn't change, but that means that we need to get going with the FH formulations. The second part was to continue to have wide support for the mechanism of action and the science behind TESA Moreland. And that's exactly what we've done, and there's nothing wrong with that. We have broadened, if anything, our support from KOL for TESA Moreland having a chance to win in NASH. And the last part was to say, once we actually complete the trial and have an indication, we need to ensure that we have a mode of administration that will be competitive. So we keep on working on getting a PEN or a method of administration that will be competitive. That's very, very important. So now if you put this all together, again, and I want to summarize, the amended protocol now, we're still waiting feedback from the agency. The financing and the partnership, that is still ongoing. But what is stalling us now moving forward is this issue related to the bacteria of static water and this global shortage. And that is serious stuff, you know, and we no longer have visibility, unfortunately. But as I stated in my speech again, I think that some hospitals now are on the priority list and maybe there are some manufacturing batches that are being released slowly, maturely, and at one point we'll be able to source that, we'll be able to manufacture ourselves, and then we'll put it all together with all the other elements to decide what's going to be the plan forward and the timeline associated to NASH. Philip, do you want to say a word on financing?
spk04: Yes, just, well, there's a few questions also on the mention of the convertible adventure that is still over a year away in terms of maturity, but we are starting to address it, and that blends in with the NASH financing as well. We've mentioned a number of times before that there is quite a bit of interest for non-diluted financing, and so everything is taken in consideration at the same time here. Obviously, If someone were to come in on a non-dilutive basis, they will want the convert to be addressed as well. So it's one whole package. So that's it for the questions Paul, so you can summarize.
spk05: Thanks Philippe and Christiane. And thank you everyone for joining our update call today. We have confirmed early on in this fiscal year that the momentum that was built in 2021 continues to sustain the growth of our commercial business. In particular, the reported 35% sales growth in EGREPTA this quarter, as well as the blended commercial sales growth of 20%, are very good signs for performance through to the remainder of the fiscal year. In conclusion, we are greatly encouraged by the data that Christian has reviewed on the call today. On the scientific side, the data that was presented at AACR is seen by Ferratechnologies as key differentiators of novel Th19O2 as a promising new therapy in solid, refractory, and metastatic cancers. Firstly, in preclinical work, we have observed enhanced effectiveness of Th19O2 versus those at Excel alone, especially in hard-to-treat refractory cancers. The capacity of Th1902 to inhibit formation of vasculogenic mimicry and growth of cancer stem-like cells can in fact be the mechanism of action at play behind those observations. And lastly, leveraging SORT1 receptors allow Th1902 to target cancer cells with a 7.5 to 10-fold concentration of the cytotoxic agent while sparing activities on normal cells, as those are known to show little to no sort of expression. Additionally, it is unfortunate that the supply chain of the necessary F8 manufacturing component has delayed development in our NASH program in the near term. However, this delay has provided us with the opportunity to remain completely focused on the brink of a very large near-term milestone including the reporting of early signs of efficacy for TH1902 from the basket trial in the second half of 2022. We will also be able to provide our utmost attention in fully onboarding of our internal tail force, which will contribute to our deliverance of guidance for the year. Following these two significant upcoming milestones, we are taking the utmost care in reviewing our national development strategy, including the seeking out of the right partners with necessary execution experience to move the program forward, alternative financing options, and optimized mode of administration to ensure patient initiation and adherence to our new formulation. For this, we hope that we have been able to share our optimism for 2022 and our progress to date with everyone today. And as we continue to move forward with both our commercial aspiration and expectations to meet forecasted revenue guidance for the full year, as we advance our pipeline across the clinic while navigating the necessary regulatory channels required to commercialize an advanced stage product with a markedly improved formulation. Have a great day and I look forward to the next update call. Thanks for attending.
spk00: Ladies and gentlemen, that is the conference for today. Thank you for your participation. You may now disconnect.
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