Millendo Therapeutics Inc. (MLND), a clinical-stage biopharmaceutical company developing novel treatments for orphan endocrine diseases, has two clinical trial catalysts to watch out for this year.
The Company has two clinical drug candidates in its pipeline – Livoletide and Nevanimibe.
Livoletide is in a pivotal phase IIb/III study for the treatment of Prader-Willi syndrome (PWS), dubbed ZEPHYR.
Prader-Willi syndrome is a rare genetic disease characterized by hyperphagia, a chronic unrelenting hunger that leads to obesity, metabolic dysfunction, reduced quality of life and early mortality.
Nevanimibe is in a phase IIb study for the treatment of classic congenital adrenal hyperplasia (CAH), the most common cause of sexual ambiguity.
The ZEPHYR trial is one of the largest PWS studies ever conducted with over 150 patients recruited across 38 clinical trial sites. The phase IIb portion of the ZEPHYR trial is fully enrolled, with topline results expected early in the second quarter of this year.
The congenital adrenal hyperplasia trial includes two distinct cohorts of patients – Cohort 1 and Cohort 2. The topline results from the phase IIb study of Nevanimibe in patients with CAH are anticipated for cohort 1 in the second half of this year.
Also in the pipeline is a preclinical program for vasomotor symptoms (VMS) associated with menopause, with first-in-human trial expected in 2020.
Recent Quarterly Scorecard:
The Company’s net loss for the quarter ended September 30, 2019 was $11.6 million or $0.87 per share compared to a net loss of $7.9 million or $10.61 per share for the same period in 2018. No revenue has been generated to date.
As of December 31, 2019, the Company had cash of $63.5 million.
MLND has traded in a range of $4.56 to $17.34 in the last 1 year. In pre-market trading today, the stock is up 0.88% at $8.00.
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