Full Press Release Details
Millendo Therapeutics Provides Corporate
- MLE-301, a selective neurokinin
3 receptor (NK3R) antagonist, advancing with first-in-human trials expected to initiate in 3Q20 -
- Further investment in nevanimibe
for congenital adrenal hyperplasia (CAH) not planned following interim data review -
- Strategic evaluation in place to determine
future corporate strategy -
ANN ARBOR, Mich., June 23, 2020 - Millendo
Therapeutics, Inc. (Nasdaq: MLND), a biopharmaceutical company primarily focused on developing novel treatments for endocrine
diseases with significant unmet needs, announced today that it has taken steps forward in its evaluation of strategic options
to determine the company's future direction. As part of these efforts, Millendo has engaged SVB Leerink to support the strategic
review process. The company finished Q1 2020 with $58.9 million in cash, cash equivalents and restricted cash.
"Our board of directors and leadership team recognize
the importance of conducting a comprehensive and strategic review. We are aligned in our focus on evaluating our pipeline and its
potential, beginning with the advancement of MLE-301," said Julia C. Owens, President and Chief Executive Officer of Millendo
Therapeutics. "Our objective is to come away from this process with an actionable plan that leverages our assets, capital
and capabilities in a way that maximizes shareholder value."
MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist,
continues to advance to first-in-human trials: An IND has been filed to study MLE-301 for the treatment of vasomotor symptoms
(VMS), also known as hot flashes and night sweats, in menopausal women. VMS currently impact 70% of peri/post-menopausal women,
representing over 20 million women in the US. Phase 1 clinical studies are expected to initiate in 3Q20.
Interim review of nevanimibe open-label Phase 2b study
in CAH completed: Results from 10 subjects, nine from cohort 1 and one from cohort 2, with at least 12 weeks of treatment
with nevanimibe in this open-label, continuous dose escalation study showed that one patient (10%) met the primary endpoint
of achieving 17- hydroxyprogesterone (17-OHP) levels less than or equal to 2-times the upper limit of normal (ULN). Treatment
under the amended protocol with dose titration starting at 500 mg BID improved tolerability of nevanimibe. However, based on
the observed level of nevanimibe activity and the changing competitive environment, no further investment in the
program is currently planned.
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 are believed 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 address vasomotor symptoms.
Nevanimibe decreases adrenal steroidogenesis through the inhibition
of acyl coenzyme A: cholesterol acyltransferase 1, or 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. These chronic high doses of cortisol can result in side effects that include diabetes, obesity, hypertension and psychological
problems. An interim review of data from the Phase 2b trial of nevanimibe in CAH (NCT03669549) was conducted; results from
10 subjects with at least 12 weeks of treatment with nevanimibe in the open-label, continuous dose escalation study showed that
one patient (10%) met the primary endpoint of achieving 17-hydroxyprogesterone (17-OHP) levels less than or equal to 2-times the
upper limit of normal (ULN).
About Millendo Therapeutics, Inc.
Millendo Therapeutics is a biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases
where current therapies do not exist or are insufficient. Millendo seeks to create distinct and transformative treatments where
there is a significant unmet medical need. The company is currently advancing MLE-301 for the treatment of vasomotor symptoms
associated with menopause. For more information, please visit www.millendo.com.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in
this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. In
some cases, you can identify forward-looking statements by the words "may," "might,"
"will," "could," "would," "should," "expect,"
"intend," "plan," "objective," "anticipate," "believe,"
"estimate," "predict," "project," "potential," "continue" and
"ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about
the future. These include statements with respect Millendo's strategic review and results thereof, Millendo's
financial condition, Millendo's future capital needs, the impact of Millendo's plan to not further invest in the
nevanimibe program, Millendo's timeline for the continued development of MLE-301 for menopausal vasomotor symptoms,
and, therefore, you are cautioned not to place undue reliance on them. Such forward-looking statements are based on
Millendo's expectations and involve risks and uncertainties; consequently, actual results may differ materially from
those expressed or implied in the statements due to a number of factors, including that Millendo has incurred significant
losses since inception, Millendo has a limited operating history and has never generated any revenue from product sales,
Millendo will require additional capital to finance its operations, Millendo's future success is dependent on the successful
clinical development, regulatory approval and subsequent commercialization of current and any future product candidates,
preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Millendo's
clinical trials may not support Millendo's product candidate claims, Millendo may encounter substantial delays in its
clinical trials or Millendo may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory
authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be
made more difficult or rendered impossible by multiple factors outside Millendo's control, Millendo's product candidates may
cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their
commercial potential, Millendo faces substantial competition and Millendo's business, preclinical studies and clinical
development programs and timelines, its financial condition and results of operations could be materially and adversely
affected by the current COVID-19 pandemic. You should refer to the risk factor disclosure set forth in the periodic reports
and other documents Millendo files with the Securities and Exchange Commission available at www.sec.gov,
including without limitation Millendo's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2020.
New factors emerge from time to time and it is not
possible for Millendo to predict all such factors, nor can Millendo assess the impact of each such factor on the business or
the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained
in any forward-looking statements. Forward-looking statements included in this press release are based on information
available to Millendo as of the date of this press release. Millendo disclaims any obligation to update such forward-looking
statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
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