On November 9, 2020 Millendo Therapeutics, Inc. (Nasdaq: MLND), a clinical-stage biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases with significant unmet needs, reported financial results for the quarter ended September 30, 2020 (Press release, Millendo Therapeutics, NOV 9, 2020, View Source [SID1234570536]).
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"We continue to advance MLE-301 as a potential alternative to hormone replacement therapy for the treatment of vasomotor symptoms (VMS) related to menopause, and were pleased to initiate our Phase 1 clinical trial in the 3rd quarter," said Julia C. Owens, President and Chief Executive Officer of Millendo Therapeutics. "MLE-301 is a priority program for Millendo, given the broader industry excitement around its potential to address a large unmet need, along with a refocusing of our internal pipeline efforts. With over 20 million women in the United States suffering from menopausal VMS, and with symptoms lasting on average over seven years, there is still a critical need for a treatment that has the efficacy of hormone replacement therapy without increased risks of cancer or cardiovascular disease."
Third Quarter 2020 and Recent Highlights
MLE-301 Phase 1 clinical trial initiated in 3Q20 as planned: A selective neurokinin 3 receptor (NK3R) antagonist, MLE-301, is being developed for the treatment of vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, in menopausal women. The single ascending dose portion of the study, being conducted in healthy male volunteers, will determine the pharmacokinetics of MLE-301 and its pharmacodynamic profile as measured by reductions of biomarkers (luteinizing hormone, testosterone). The multiple ascending dose portion will enroll post-menopausal women, with the goal of measuring reductions in VMS frequency and severity and establishing initial clinical proof of concept. The company continues to monitor the COVID-19 pandemic closely and will provide updates pending any potential impact to trial enrollment.
Nevanimibe program for patients with congenital adrenal hyperplasia (CAH) winding down: Further investment in the development of nevanimibe as a potential treatment for CAH has ceased, and out-licensing options are being explored.
Comprehensive evaluation of strategic options continues: SVB Leerink is supporting a strategic review process to build an actionable plan leveraging the company’s assets, capital and capabilities to maximize shareholder value.
Third Quarter 2020 Financial Results
Cash Position: Cash, cash equivalents and restricted cash were $43.8 million at September 30, 2020, compared to $63.5 million at December 31, 2019.
Research and Development (R&D) Expenses: R&D expenses were $2.7 million for the third quarter 2020, as compared to $7.3 million for the same period in 2019. The decrease in R&D expenses was primarily driven by decreased spend due to discontinuing our development of the livoletide program and ceasing investing in the nevanimibe program, offset by increased spend on MLE-301.
General and Administrative (G&A) Expenses: G&A expenses were $3.4 million for the third quarter 2020, as compared to $4.4 million for the same period in 2019. The decrease in G&A expenses was primarily driven by decreased professional fees as a result of lower accounting and consulting fees incurred as compared to the prior period. Compensation and stock-based compensation decreased as a result of a decrease in our general and administrative headcount and changes to compensation arrangements.
Net Loss: The company’s net loss for the quarter ended September 30, 2020 was $6.4 million as compared to $11.6 million for the same period in 2019.
2020 Financial Guidance
Millendo expects that its cash, cash equivalents and restricted cash will support its current development and operational plans into 2022.
About MLE-301
MLE-301 is a neurokinin 3 receptor (NK3R) antagonist that is being developed as a potential treatment of vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, in menopausal women. NK3R plays a key role in regulating the activity of KNDy (kisspeptin/NKB/dynorphin) neurons, which has been shown to participate in the generation of VMS. By inhibiting the NK3R signaling on the KNDy neurons and potentially other NK3R-expressing neurons that propagate heat dissipation signals through the hypothalamus, MLE-301 aims to reduce the effects of hyperactive KNDy neurons and thereby decrease the frequency and severity of vasomotor symptoms.