Theratechnologies Inc.

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.

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.

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?