Millendo loss grows, but drug candidates show promise

ANN ARBOR—Millendo Therapeutics Inc., (Nasdaq: MLND), a clinical-stage pharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases with significant unmet needs, provided a corporate update and reported financial results for the quarter ended Sept. 30.

Millendo is testing a drug called livoletide to treat hyperphagia, chronic unrelenting hunger, in patients with Prader-Willi Syndrome, a complex genetic disorder that causes excess appetite, leading to obesity and Type 2 diabetes. It is also testing a drug called nevanimibe in CAH, congenital adrenal hyperplasia, a group of rare inherited disorders characterized by a deficiency of one of the enzymes needed to make specific hormones, which can affect normal growth and cevelopment.

Said Millendo President and CEO Julia C. Owens: “We are excited about the potential for livoletide to treat hyperphagia and other food-seeking behaviors that lead to morbidity and mortality in these patients, as well as significant caregiver burden. In addition, our Phase 2b clinical study of nevanimibe in CAH is continuing recruitment across its two cohorts, providing us with further insights on the activity of nevanimibe over longer treatment periods and in CAH patients where steroid doses are reduced. We expect to report topline results from the study’s first cohort in the second half of 2020.”

The company reported cash, cash equivalents, marketable securities and restricted cash were $48.3 million at Sept. 30, down from $78.2 million at Dec. 31. R&D expenses were $7.3 million for the third quarter of 2019, up from $3.9 million for the same period in 2018. The increase in R&D expenses was primarily driven by increased spending on the company’s pivotal Phase 2b/3 study of livoletide in PWS and higher compensation expenses as a result of increased headcount.

General and administrative expenses were $4.4 million for the third quarter of 2019, up from $3.9 million for the same period in 2018. The increase in G&A expenses was primarily driven by higher compensation expense as a result of increased headcount and increased expenses to support ongoing business operations and obligations associated with being a publicly traded company.

The company’s net loss for the quarter ended Sept. 30 was $11.6 million, compared to $7.9 million for the same period in 2018.

Millendo officials said they expect that cash, cash equivalents, marketable securities and restricted cash will support the company’s capital needs through the fourth quarter of 2020, beyond the readout for the topline results of the Phase 2b portion of the pivotal Phase 2b/3 study of livoletide in PWS, which is expected in the first half of 2020.

Millendo has received both Orphan Drug Designation and Fast Track Designation for livoletide for the treatment of PWS from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency (EMA). For more information about Millendo’s pivotal study of livoletide (ZEPHYR) please visit www.clinicaltrials.gov (NCT03790865) or the Patients and Families portion of Millendo’s website.

Nevanimibe decreases adrenal steroidogenesis through the inhibition of ACAT1 and is being studied for the treatment of classic congenital adrenal hyperplasia (CAH). CAH is a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses, which can make it difficult for physicians to appropriately treat CAH without causing adverse consequences. In a Phase 2 proof-of-concept clinical trial in patients with CAH, Millendo observed nevanimibe to be associated with clear signs of clinical activity in seven of 10 treated patients. A Phase 2b trial of nevanimibe in CAH (NCT03669549) is ongoing.

Millendo is currently advancing livoletide for the treatment of Prader-Willi syndrome, nevanimibe for the treatment of classic congenital adrenal hyperplasia and MLE-301 for the treatment of vasomotor symptoms associated with menopause. For more information, visit www.millendo.com.

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