Mr. Paul Levesque reports
THERATECHNOLOGIES ANNOUNCES PRELIMINARY FOURTH QUARTER AND FULL FISCAL YEAR 2020 REVENUES AND PROVIDES UPDATE ON R&D ACTIVITIES
Theratechnologies Inc. has provided net revenue estimates for its fourth quarter and its full fiscal year ended Nov. 30, 2020, and has provided an update on its research and development activities.
Consolidated net revenues for the company's fourth quarter fiscal year 2020 are expected to be between $18.9-million (U.S.) and $19.2-million (U.S.), compared with $16.4-million (U.S.) for the same quarter last year, representing an increase of approximately 15 per cent to 17 per cent, and the company's highest reported quarterly revenues to date.
Consolidated net revenues for the company's full fiscal year 2020 are expected to be between $65.8-million (U.S.) and $66.1-million (U.S.), compared with $63.2-million (U.S.) for the fiscal year ended Nov. 30, 2019, representing an increase of approximately 4.1 per cent to 4.6 per cent, and the company's highest reported annual revenues to date.
"Despite the current pandemic, we delivered record sales in the fourth quarter of our 2020 fiscal year. We believe that the changes we implemented to our sales infrastructure and commercial strategies at the beginning of the fourth quarter have started to positively impact our business. Looking ahead, our goals remain to expand our commercial business and to advance our promising pipeline, further strengthening our foundation for sustained growth," said Paul Levesque, president and chief executive officer, Theratechnologies.
R&D (research and development) update
Tesamorelin for the treatment of NASH
In November, 2020, Theratechnologies filed an investigational new drug (IND) application with the United States Food and Drug Administration (FDA) for the phase 3 development of tesamorelin for the treatment of adults with NASH with liver fibrosis. The company announced today that it has received a study may proceed letter from the FDA for the phase 3 trial with a recommendation that the company requests a meeting to discuss questions and comments received on certain aspects of the proposed trial design, to ensure alignment with the agency's expectations with NASH trials. The company intends to follow up on the FDA's recommendation and will formally request a meeting with the agency.
The proposed phase 3 trial design will enroll participants with liver-biopsy-confirmed NASH and stage 2 or 3 fibrosis. Participants will be randomized 1:1 to receive two milligrams of tesamorelin or placebo. A second liver biopsy will be performed after 18 months of treatment for the first 900 participants, approximately. These data will form the basis for filing a supplemental biologics licence application (sBLA) with the FDA to seek accelerated approval.
The primary end point used to seek accelerated approval will be the percentage of participants achieving NASH resolution and no worsening of fibrosis compared with placebo.
Participants will remain in the phase 3 trial for a total of 60 months. Approximately 2,000 participants in total are expected to be enrolled including a cohort of approximately 75 to 100 participants with HIV.
Theratechnologies' goal is to initiate the phase 3 trial by the end of the third quarter of calendar year 2021. The final timing of the trial initiation is dependent upon any adjustments to the protocol and trial design as recommended by the FDA and European agencies. Any changes to the trial design or expected timelines based on discussions with the FDA will be disclosed thereafter.
SORT1+ Technology in oncology
In December, 2020, the company filed an IND application with the FDA for the development of TH1902, its lead peptide-drug conjugate (PDC) (docetaxel conjugate) derived from its SORT1+ Technology platform, for the treatment of various cancers. The IND application was based on preclinical data obtained in endometrial, ovarian, colorectal, pancreatic and triple-negative breast (TNBC) cancers.
Theratechnologies announced today that it has received a study may proceed letter from the FDA for the phase 1 trial. The proposed phase 1 trial design includes a dose-escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumour activity of TH1902 administered once every three weeks in patients with advanced solid tumours refractory to available anti-cancer therapies. Once the MTD is determined, a total of 40 additional patients will be enrolled to evaluate the potential anti-tumour activity of TH1902 in patients with endometrial, ovarian, colorectal, TNBC and pancreatic cancer. The phase 1 trial is expected to be initiated in the second quarter of calendar year 2021 and is designed to identify a recommended dose for phase 2 development. The preclinical evaluation of TH1902 in melanoma is continuing.
"I am extremely pleased with the efforts of our teams to achieve these two remarkable milestones that will provide tremendous opportunity for the company. Theratechnologies is in an enviable position with growing sales and a pipeline that has strong potential to address high unmet medical needs," concluded Mr. Levesque.
About Theratechnologies Inc.
Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.
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