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THERA technologies Theratechnologies Reports Financial Results for the Second Quarter of Fiscal 2021 and Provides Update on Its Planned Phase 3 Clinical Trial in NASH July 15 , 2021 MONTREAL , July 15 , 2021 ( GLOBE NEWSWIRE ) Theratechnologies , Inc. ( Theratechnologies , or Company ) ( TSX : TH ) ( NASDAQ : THTX ) , a biopharmaceutical company focused on the development and commercialization of innovative therapies , today reported financial results for the second quarter ended May 31 , 2021 ( Q2 Fiscal 2021 ) and provided an update on its planned Phase 3 clinical trial evaluating tesamorelin for the treatment of nonalcoholic steatohepatitis ( NASH ) . Second - Quarter 2021 Revenues ( in thousands of U.S. dollars ) EGRIFTAⓇ , EGRIFTA SVⓇ net sales Trogarzo net sales Revenue Three Months Ended May 31 , 2021 10,344 7,443 17,787 May 31 , 2020 9,269 7,893 17,162 % change 12 % -6 % 4 % The Company also announced that discussions with the U.S. Food and Drug Administration ( FDA ) and the European Medicines Agency ( EMA ) regarding its proposed trial design and protocol for its Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH are complete . In addition , the Company has initiated a search for a potential partner to help launch the program . " The first half of 2021 has been marked by progress across our R & D pipeline of novel compounds . Our Phase 1 clinical trial of TH1902 for the treatment of sortilin - expressing cancers progressed as planned during the quarter and we believe that we have developed a targeted peptide - drug conjugate that may potentially transform the way cancer is treated . In NASH , we concluded regulatory discussions in the U.S. and EU and now have a ready - to - proceed Phase 3 clinical trial design , " said Paul Lévesque , President and Chief Executive Officer , Theratechnologies . Update on Phase 3 clinical trial evaluating tesamorelin in NASH • Discussions with the FDA and the EMA on the trial design are complete . • The Phase 3 clinical trial will include participants in the U.S. and Europe . • The Phase 3 clinical trial will be a multicenter , double - blind , placebo - controlled two - part study to evaluate the safety and efficacy of tesamorelin in liver - biopsy confirmed patients with NAS score of at least 4 and stage 2 or 3 fibrosis . • The Phase 3 clinical trial will include a futility analysis that will be performed after approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy . • A supplemental Biologics Licence Application ( SBLA ) is expected to be filed after approximately 1,100 patients , including approximately 75 to 100 people living with HIV , have completed 18 months of treatment and have received a second liver biopsy . • The primary endpoint will be NASH resolution and no worsening of fibrosis compared to placebo after 18 months as per FDA guidelines . • Following potential approval , an additional 1,800 patients are expected to be enrolled , to continue measuring clinical outcomes over a period of five years . • Based on regulatory discussions , the final Phase 3 clinical trial design will result in higher costs than what the Company had previously estimated . • As a result of the total cost of the Phase 3 clinical trial , the Company is now evaluating its options to best execute its late - stage development program , including seeking a potential partner . • An external U.S. - based biopharma advisory firm has been retained to assist in identifying a potential partner . • Partner identification and negotiations will alter the initiation of the Phase 3 clinical trial that was previously expected to begin in the third quarter of calendar year 2021 . " Given the additional resources required to conduct the Phase 3 clinical trial in NASH , we are evaluating opportunities that will allow us to most