Millendo Therapeutics

Millendo Therapeutics was a biopharmaceutical firm focused on addressing orphan endocrine diseases. Julia C. Owens, Ph.D., co-founded the Ann Arbor-based company in 2012 and served as its President and CEO for nine years. Her background includes a Ph.D. in biochemistry and business development roles at companies like Lycera Corp., QuatRx Pharmaceuticals, and Tularik Inc., providing a foundation in both the scientific and strategic aspects of the biotechnology sector.

The company's business model centered on the development and commercialization of novel therapeutics for conditions with significant unmet medical needs. In August 2018, Millendo went public on the Nasdaq through a reverse merger with OvaScience, a move that provided the capital to advance its clinical programs. This transaction was structured to give Millendo's shareholders a majority stake in the newly combined entity, which continued under the Millendo Therapeutics name and the leadership of Julia Owens.

Millendo's clinical pipeline featured two main product candidates. The first, livoletide, was an unacylated ghrelin analogue developed to treat the hyperphagia (unrelenting hunger) associated with Prader-Willi syndrome (PWS). The second candidate, nevanimibe, was an ACAT1 inhibitor aimed at treating rare adrenal diseases, including Classic Congenital Adrenal Hyperplasia (CAH) and Endogenous Cushing’s Syndrome, by reducing the overproduction of adrenal steroids.

Despite initial promise, the company faced significant setbacks. In April 2020, Millendo announced that the pivotal Phase 2b study for livoletide did not meet its primary endpoint, failing to show a statistically significant improvement in hyperphagia compared to a placebo. This led to the discontinuation of the livoletide development program. Subsequently, development of nevanimibe was also halted following an interim data review that showed insufficient efficacy. These clinical trial failures prompted a major corporate restructuring in January 2021, which included a workforce reduction of up to 85%. Following these events, Millendo entered into a definitive merger agreement with Tempest Therapeutics in March 2021. The all-stock transaction closed in June 2021, with the combined company operating as Tempest Therapeutics and focusing on Tempest's oncology pipeline.

Keywords: Millendo Therapeutics, endocrine diseases, Julia C. Owens, livoletide, nevanimibe, Prader-Willi syndrome, Congenital Adrenal Hyperplasia, Cushing’s Syndrome, orphan drugs, biopharmaceutical, reverse merger, OvaScience, Tempest Therapeutics, clinical trials, ACAT1 inhibitor, ghrelin analogue, adrenal disease treatment, rare genetic disorders, pharmaceutical development, biotechnology finance