Theratechnologies Inc.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Thera Technologies third quarter 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. Instructions will be provided at that time for you to queue up for questions. In addition, questions will be able to be submitted in written form via the webcast platform. If anyone has any technical difficulties hearing the prepared remarks or during the Q&A portion of the call, please press the star key followed by zero for operator assistance at any time. I would now like to remind everyone that this conference call is being recorded today, Wednesday, October 13, 2021, at 8.30 a.m. Eastern Time. I will now turn the call over to Thera Technologies Head of Investor Relations, Leah Gibson. Ms. Gibson, please go ahead.

Thank you, Catherine, and welcome, everyone. Mr. Paul Levesque, President and Chief Executive Officer of Thera Technologies, and Mr. Philippe Debuc, Senior Vice President and Chief Financial Officer, will be the speakers on today's call. A Q&A session will follow their prepared remarks. Before we begin, 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 and developments. In preparing these forward-looking statements, several assumptions were made by Thera Technologies, and there are risks that actual results obtained by the company will differ materially from those statements. As a result, the company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. Thera Technologies refers current and potential investors to the forward-looking information section of its management discussion and analysis issued this morning, available at CEDAR.com and on EDGAR at SEC.gov. Forward-looking statements represent Thera Technologies' expectations as of October 13, 2021. Except for that which is required by securities laws, Thera Technologies 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 call over to Paul. Paul?

Thank you, Leah. Good morning, everyone, and thank you for being with us today. I'm very pleased to provide an update on where Thera Technologies stands in our effort to build upon the clear and strong operational results that have been achieved in fiscal 2021 thus far. At the beginning of the fiscal year, we set forth a logical strategic plan to lead the company toward inevitable growth and transformation in our commercial and investigational pipelines. As we move well into the back half of our fiscal year, our efforts are beginning to show fruit We're continuing to further unlock the unrealized value held in our commercial business through product lifecycle management and innovation, while at the same time building on the vital body of proof of concept work needed to advance the promising therapeutic potential of our investigational oncology portfolio and phase three development programs in NASH. To this end, we are extremely excited about the progress made in the Phase 1 study evaluating our novel peptide drug conjugate, TH19O2, for the treatment of sortaline-positive cancers. As you recall, we received fast-track designation from the FDA in January 2021, recognizing TH19O2 in our SORT1 positive technology as a broadly applicable cancer-agnostic treatment for patients with sortaline-expressing solid tumors. This morning, we provided an interim safety update, noting that to date, we have dosed several patients in Part D of the study, with some participants receiving more docetaxel when conjugated to Th1902 than the indicated dose of docetaxel alone. Additionally, patients that have received up to 300 mg per square meter of Th1902, which is equivalent to approximately 1.5 times the indicated therapeutic dose of docetaxel have not experienced any grade 2 adverse events. The last patient that was dosed in the trial received 420 mg per square meter of TH19O2, or approximately two times the indicated dose or dose at XL, and at that level, the patient experienced grade 4 neutropenia. We are now awaiting all safety information to come in, so we may assess the next dosing level and pursue the study as per the approved protocol design. As a reminder, Part A dose escalation study of the Phase I trial is primarily meant to establish the maximum tolerated dose. While we have not yet identified what the maximum tolerated dose will be, what we have observed thus far is very encouraging because it seems that Th19u2 is better tolerated than dose effects alone. Furthermore, in our preclinical work, we have demonstrated that Th1902 can potentially penetrate the cancer cell far more effectively than docetaxel alone and increase the concentration of docetaxel specifically where it counts, in the cancer cells. Th1902 is targeting the SORT1 receptor, which is a very prominent receptor in many solid tumors. In terms of next steps, For this program, we will plan to provide another update of the Phase 1 Part A study when we have reached the maximum tolerated dose of Th1902, at which time we may have early signs of efficacy data to report. We continue to expect initiating the Part B basket trial in the U.S. and Europe in early 2022. As one of the only biotech companies currently targeting sort 1 receptor in the treatment of cancer, We are fully committed to this journey of pioneering a novel and potentially transformational treatment to a broad class of hard-to-treat cancers. Therefore, we're taking the same approach to garnering scientific support for this program as we did for our Phase III program in NASH. Aligned with this strategy follows the appointment of Dr. Mays Ruffenberg as a scientific advisor for our SORT1 positive technology oncology platform. We are very excited to have Mace as part of our team as he brings more than 30 years experience across government, academia, and the biopharmaceutical industry, most recently serving as Chief Medical Officer at Pfizer before his retirement earlier this year where I had the opportunity to work with him. During his time at Pfizer as CMO, the company initiated, completed, and obtained emergency use authorization for its COVID-19 vaccine and obtain regulatory approval for 11 new cancer medicines. MACE will no doubt be an important advisor to Theratechnologies as we advance our oncology platform through development and toward approval. We are also looking at additional opportunities to extend the regulatory and commercial scope for Th1902 in other geographies. Currently, we are exploring potential cooperation and alliances with China-based organizations to evaluate Th1902 in patients in greater China that are suffering from sort of inexpressing cancers. By gaining the support and scientific expertise of a locally-based organization to help us develop Th1902, we are better positioning ourselves to bring this potential treatment to patients faster and more effectively, which is at the foundation of our oncology strategy. As we think about the future objectives of our Sort 1 positive technology platform, there are a number of additional value-driving opportunities that we will work toward, including evaluating different dosing schedules, such as weekly or interminably, that may potentially increase the therapeutic window in terms of safety and efficacy, exploring the possibility of conjugating with different anti-cancer agents, including cytotoxics, like SN38, in ironotican, NTKIs, and evaluating synergistic partnerships, and finally exploring the rational combination with other cancer treatments, especially immunotherapies. But for the near term, we remain focused and committed to completing our first one or phase one trial as quickly as possible. Turning to our phase three program in NASH, The company continues to evaluate our options to most effectively execute the Phase III clinical trial up to some order for the treatment of NASH, which includes seeking a potential partner. As we announced in our last earnings call, an external U.S.-based biopharma advisory firm was retained to assist in identifying a potential partnership for this program, and we also explore other opportunities to initiate the trial in a timely manner. In support of these initiatives, we recently hosted a virtual NASH webinar featuring Dr. Rohit Lumba, Stephen Harrison, and Steve Greenspoon, who are key opinion leaders in hepatology, endocrinology, and NASH. The event provided a deep dive into our innovative approach to treating NASH in Thessalonica and also demonstrated the distinct support this program has from these leading disease and industry experts. We look forward to updating you on the advancement of our NASH program soon. Moving on to the commercial side, we're happy to report on the uptick in activity and demand for a crypto-SV for the Tweedler-Lyco district. While the COVID pandemic was an unfortunate and unforeseeable event, which has no doubt materially impacted most of the healthcare industry, We want to know that in many ways the pandemic's transformational pressures have only accelerated the healthcare industry's need to move toward digital health, which has been an ongoing presence in healthcare for the past decade. Engagement between HCPs and the patient care journey have increasingly shifted toward new behavioral patterns that are largely driven by a need for better technology and immediate access to HCPs. When I came on board at Ferra Technologies, we made the conscious decision to move the company toward this path, and coincidentally, at the start of the pandemic. Since then, we have challenged the fundamentals of our business, developing a mature business acumen, which includes a more focused field force and digitalized training and product education tools, and have ultimately created a solid go-to-market model. As a result, Sales increased nearly 30% in the third quarter over 2021 over last year, supported by a 65% increase in EGRIFTA SV sales. The improvement in EGRIFTA SV sales is a direct result of a return to some face-to-face meetings and greater and more efficient digital campaigning and technical education, which also led to a 40% increase in new prescribers during the quarter. Based on this momentum, we believe we have begun to revert back to a pre-COVID sales environment, but with a much better level of cross-functional team execution, creating a springboard for growth for our approved medicines. In terms of market expansion in HIV beyond our existing markets, we have also made progress toward securing pricing and reimbursement agreements with Trigarzo in several countries outside of the U.S., including Italy most recently, which is an integral part of our Trigarzo growth strategy. Specific to our progress in the Italian market, our technologies and the Italian Medicines Agency recently reached a reimbursement agreement for Trigarzo, and we expect that this medicine will become commercially available to all eligible patients in Italy by the end of fiscal year 2021. Our life cycle management strategy for Tregarzo is also progressing nicely. Most recently, we announced results for the TMB-302 study evaluating an IV push mode of administration of Tregarzo in HIV-1 patients. This internal study achieved consistent and statistically significant results demonstrating that there was no difference in pharmacokinetics between the IV push and the current IV infusion mode of administration. This more convenient IV push mode of administration requires only two quick infusions per month, offering patients a rapid infusion time, thereby potentially increasing patient compliance and allowing patients to benefit from long-acting protection against HIV-1 when Trogarzo is administered with other antiretrovirals. Based on the results of the IV push study, we plan to file an SBLA with the FDA during this quarter. In addition, patient screening to evaluate an intramuscular, or IM, method of administration of Tregazo is also planned to begin this quarter. Further supporting our growth strategy for Tregazo is our plan to initiate a post-authorization study named the Tregazo Promise Trial, that will evaluate the real-world long-term efficacy and safety of Trogarzo in combination with other anti-retrovirals. The study is expected to enroll patients in the EU during this quarter, while a similar study will be initiating in the U.S. in the first quarter of 2022. Enhancing our portfolio of real-world evidence for Trogarzo will provide our field force with additional and important market data to support their discussions with patients and HCPs. Based on today's business update, it is clear to see that we are proceeding as planned and executing against the goals that we have rolled out at the beginning of this year. In oncology, we are extremely pleased and encouraged by the early indication that the Phase 1 Part A study in TH1902 have demonstrated and look forward to both interim and full data readouts in this program over the next several quarters. We're also encouraged by the current commercial landscape that has begun to show signs of recovery and expanding market penetration as we continue to unlock the intrinsic value held in our Egrifta SB Intragarso medicines for HIV. And we continue to work tirelessly to evaluate opportunities to most effectively execute our Ready to Proceed Phase 3 program in NASH and advance this exciting program toward a potential approval. With that, I will turn the call over to Fidip, who will provide the Q3 financial summary. Fidip.