Millendo Therapeutics Provides Pipeline and Business Update
January 05 2021 - 8:00AM
Business Wire
– Further investment in MLE-301, a selective
neurokinin 3 receptor (NK3R) antagonist, not planned following
initial review of data from Phase 1 clinical study –
– Company exploring expanded range of strategic
alternatives to maximize its assets –
Millendo Therapeutics, Inc. (Nasdaq: MLND), announced today that
its Board of Directors has decided to discontinue further
investment in MLE-301, a selective neurokinin 3 receptor (NK3R)
antagonist for the treatment of menopausal vasomotor symptoms
(VMS), based on an analysis of the pharmacokinetic and
pharmacodynamic data from the ongoing single ascending dose portion
of the Phase 1 study being conducted in healthy male volunteers.
While MLE-301 was generally well-tolerated, the data do not support
moving forward with its development in the target population of
peri- and post-menopausal women, especially with the evolving
dynamics of a highly competitive NK3R antagonist market.
Given the Company’s limited expected financing options,
Millendo’s Board of Directors has determined that it is in the best
interests of the Company’s shareholders to explore an expanded
range of strategic alternatives that include, but are not limited
to, the potential sale or merger of the Company or its assets.
Millendo will continue working with SVB Leerink to assist in its
ongoing strategic process.
Carol Gallagher, Chairman of the Board, commented, "We would
like to acknowledge and thank all of our employees for their hard
work in supporting Millendo’s mission of pursuing novel therapies
to alleviate patient suffering due to endocrine diseases. The Board
has continued to support the Company’s ongoing plans and execution
efforts; however, at this time the Board believes that it is in the
best interest of the Company and its shareholders to actively seek
a broad range of strategic alternatives, including a sale or merger
of the Company in order to maximize shareholder value.”
To conserve cash, Millendo intends to review its operating costs
and may plan for a reduction in its workforce in order to focus its
resources on essential business activities.
No assurance can be given regarding the outcome or timing of the
strategic review process. Millendo does not intend to discuss or
disclose further developments regarding the strategic review
process unless and until its Board of Directors has approved a
specific action or otherwise determined that further disclosure is
appropriate or required by law.
About MLE-301
MLE-301 is a neurokinin 3 receptor (NK3R) antagonist that
Millendo was developing as a potential treatment of 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.
About Millendo Therapeutics, Inc.
Millendo Therapeutics is a clinical-stage 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. 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 to the company’s plan to cease investing in MLE-301 and its
ongoing strategic review process, 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 September 30, 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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version on businesswire.com: https://www.businesswire.com/news/home/20210105005561/en/
Millendo Investor: Jack Hildick-Smith Stern Investor
Relations 914-610-6811 Jack.Hildick-Smith@Sternir.com
Millendo Media: Julie Bane MacDougall 617-821-1089
jbane@macbiocom.com
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