Theratechnologies Inc.

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.

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.

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?