Ladenburg Thalmann launched coverage of Millendo Therapeutics (NASDAQ:MLND) with a “buy” rating and $29 price target. The stock closed at $7.65 on Jan. 3.
Millendo is a clinical-stage company focusing on the development of novel treatments for orphan endocrine diseases where there is a significant unmet medical need. In December 2018, Millendo completed a merger with Ovascience. Millendo had $85.4-million in cash following the transaction, which it believes would provide about two years of funding.
Analyst Matthew Kaplan writes that Millendo is currently focused on two lead product candidates; livoletide for the treatment of Prader-Willi syndrome (PWS) and nevanimibe as a treatment for congenital adrenal hyperplasia (CAH).
He expects Millendo to initiate a Phase 2b/3 study with livoletide in the first quarter of 2019, with initial top-line results in the first half of 2020 and an NDA filing by the first half of 2021.
“We believe livoletide could offer a game changing product profile for the treatment of PWS with greater than $650-million of revenue in the U.S. by 2030,” Mr. Kaplan said.
Millendo initiated a Phase 2b study with nevanimibe in August 2018, with full study data expected in the first half of 2020. “However, as the Phase 2b trial is an open-label study, we believe there is potential for interim [data] to be announced in 2019,” he added.
Mr. Kaplan expects Millendo to initiate a Phase 3 CAH study in the first half of 2021, with top-line data expected in the second half of 2023. Based on this timeline, he said an NDA filing could be made in the second half of 2024. “We believe nevanimibe could generate more than $320-million in net revenue in the U.S. by 2030,” he added.
