– 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 –
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.
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 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.
About Nevanimibe
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200623005296/en/
Millendo Investor Contact: Connie Chang Millendo
Therapeutics 734-864-8006 chang@millendo.com
Millendo Media Contact: Julie Bane MacDougall
617-821-1089 jbane@macbiocom.com
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