ANN ARBOR—Millendo Therapeutics Inc. (Nasdaq:MLND), a clinical stage biopharmaceutical company developing novel treatments for endocrine diseases with significant unmet needs, reported a loss of $12 million or 65 cents per share, compared to a loss of $10.4 million or 78 cents per share in the first quarter of 2019.
It was the first financial report for the company since it announced it was abandoning development of a novel drug called livoletide to treat Prader-Willi Syndrome, after disappointing clinical trial results.
“As we wind down activities related to the livoletide program, we have moved quickly to streamline costs and redeploy development efforts to our other portfolio programs,” said Julia C. Owens, Millendo president and CEO. “We are currently evaluating our business strategy, taking into consideration our existing pipeline assets, assessing the evolving impact of the global COVID-19 pandemic and leveraging the deep development expertise of our leadership team to investigate potential strategic additions to our portfolio.”
Prader-Willi syndrome is a complex genetic condition that affects many parts of the body. In infancy, this condition is characterized by weak muscle tone, feeding difficulties, poor growth, and delayed development. Beginning in childhood, affected individuals develop an insatiable appetite, which leads to chronic overeating and obesity. Livoletide was abandoned because a clinical trial did not result in a statistically significant improvement in overeating and food-related behaviors compared to placebo.
Company officials said that due to the coronavirus pandemic, they also have stopped enrolling new patients in a Phase 2 clinical trial of a drug candidate called nevanimibe for congenital adrenal hyperplasia, another complex endocrine disorder where a lack of production of cortisol and aldosterone and excess production of male sex hormones can cause problems in maintaining blood sugar, low blood pressure, short height, early puberty, and abnormal genital development. The company said it anticipates an interim review of results in patients already enrolled by Sept. 30.
The company also said it anticipates starting clinical trials in the second half of 2020 of a new drug called MLE-301 to treat hot flashes and night sweats in menopausal women.
Research and development expenses were $7.5 million for the first quarter, up from $6.2 million for the same period in 2019. Company officials said the increase was the product of the livoletide study, which has since been discontinued. General and administrative expenses were $4.6 million in the first quarter, up from $4.5 million in the same period of 2009. Employee expenses rose while professional fees declined.
Millendo officials said they expect that cash, cash equivalents and restricted cash will support the company’s current development and operational plans into 2022.
More at www.millendo.com.