Benzinga | Jul 15, 2021 07:56AM EDT

Theratechnologies In Search Of Potential Partner For Late-Stage NASH Study Of Tesamorelin, Reports Q2 Earnings

* Theratechnologies Inc (NASDAQ:THTX) has completed discussions with the FDA and European Medicines Agency regarding its proposed trial design and protocol for its Phase 3 trial for tesamorelin in nonalcoholic steatohepatitis (NASH).

* The trial will include a futility analysis after approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy.

* A supplemental marketing application is expected to be filed after approximately 1,100 patients, including about 75 to 100 HIV patients, have completed 18 months of treatment and have received a second liver biopsy.

* Following potential approval, an additional 1,800 patients are expected to be enrolled to continue measuring clinical outcomes over five years.

* The Company says that the final Phase 3 trial design will result in higher costs than previously estimated.

* As a result, the Company has initiated a search for a potential partner to help launch the program. An advisory firm has been retained.

* Partner identification and negotiations will alter the initiation of the Phase 3 trial that was previously expected to begin in Q3 of 2021.

* The Company reported Q2 sales of $17.8 million, +4% Y/Y propelled by higher Egrifta sales of $10.3 million, +12%.

* Trogarzo sales declined 6% to $7.4 million on lower unit sales as patients refrained from visiting their physicians. Competitive pressures and higher rebates also impacted the sales.

* It posted a net loss of $(0.07) for the quarter compared to $(0.08) a year ago.

* The Company had $56.7 million in cash, sufficient to fund the Company's operations for at least the next twelve months.

* Price Action: THTX shares closed at $3.68 on Wednesday.