Millendo Therapeutics, Inc. (Nasdaq:MLND), a clinical stage
biopharmaceutical company primarily focused on developing novel
treatments for endocrine diseases with significant unmet needs,
today provided a corporate update and reported financial results
for the quarter ended March 31, 2020.
“As we wind down activities related to the livoletide program,
we have moved quickly to streamline costs and redeploy development
efforts to our other portfolio programs, nevanimibe for congenital
adrenal hyperplasia and MLE-301 for menopausal vasomotor symptoms,”
said Julia C. Owens, President and Chief Executive Officer of
Millendo Therapeutics. “We are currently evaluating our business
strategy, taking into consideration our existing pipeline assets,
assessing the evolving impact of the global COVID-19 pandemic and
leveraging the deep development expertise of our leadership team to
investigate potential strategic additions to our portfolio.”
First Quarter 2020 and Recent Highlights
- Discontinuation of the livoletide program in Prader-Willi
syndrome (PWS): Topline data from the Phase 2b ZEPHYR study of
livoletide in PWS were announced on April 6, 2020, and showed that
treatment with livoletide did not result in a statistically
significant improvement in hyperphagia and food-related behaviors
compared to placebo, as measured by the Hyperphagia Questionnaire
for Clinical Trials. As a result, the company discontinued the
program and initiated staffing reductions. Final data tables and
listings are currently being reviewed but are not anticipated to
alter the topline conclusions of the study.
- Interim review of data expected by 3Q20 for ongoing Phase 2b
study of nevanimibe in patients with classic congenital adrenal
hyperplasia (CAH): Due to the continued global COVID-19
pandemic, new patients are not being actively enrolled in the
open-label, Phase 2b nevanimibe study in CAH at this time, as is
the case for many clinical studies worldwide. The company expects
to conduct an interim review of the current dataset for enrolled
patients by 3Q20.
- MLE-301 expected to initiate Phase 1 clinical trials in 2H20
as planned: A selective neurokinin 3 receptor (NK3R)
antagonist, MLE-301 is intended for the treatment of vasomotor
symptoms (VMS), commonly known as hot flashes and night sweats, in
menopausal women. Due to the well-established role of NK3R in VMS,
MLE-301 may have meaningful potential in an area of high unmet
medical need.
First Quarter 2020 Financial Results
Cash Position: Cash, cash equivalents and restricted cash
were $58.9 million at March 31, 2020, compared to $63.5 million at
December 31, 2019.
Research and Development (R&D) Expenses: R&D
expenses were $7.5 million for the first quarter 2020, as compared
to $6.2 million for the same period in 2019. The increase in
R&D expenses was primarily driven by increased spending on the
company’s Phase 2b study of livoletide in PWS, which has since been
discontinued.
General and Administrative (G&A) Expenses: G&A
expenses were $4.6 million for the first quarter 2020, as compared
to $4.5 million for the same period in 2019. The increase in
G&A expenses was primarily driven by increased costs related to
employee compensation offset by lower professional fees as compared
to the prior period.
Net Loss: The company’s net loss for the quarter ended
March 31, 2020 was $12.0 million as compared to $10.4 million for
the same period in 2019.
2020 Financial Guidance
Millendo expects that its cash, cash equivalents and restricted
cash will support the company’s current development and operational
plans into 2022.
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.
Millendo has received Orphan Drug Designation for nevanimibe for
the treatment of CAH from the U.S. Food and Drug Administration and
the European Medicines Agency. In a Phase 2a clinical trial in
patients with CAH, Millendo observed nevanimibe to be associated
with clear signs of clinical activity in seven of 10 treated
patients. A Phase 2b trial of nevanimibe in CAH (NCT03669549) is
ongoing.
About MLE-301 MLE-301 is a neurokinin 3 receptor (NK3R)
antagonist that is being developed 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 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 the excessive heat dissipation
signaling associated with VMS. MLE-301 is currently in preclinical
studies designed to enable first-in-human clinical studies.
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. The company is currently advancing
nevanimibe for the treatment of classic congenital adrenal
hyperplasia and 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 to the impact of the COVID-19 pandemic on Millendo’s
business, preclinical studies and clinical development programs and
timelines, Millendo’s financial condition and results of
operations, Millendo’s future capital needs, the impact of
Millendo’s discontinuation of the PWS program, Millendo’s plans to
potentially in-license, acquire and develop additional product
candidates and the timelines for the continued development of
nevanimibe for congenital adrenal hyperplasia and 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 Annual Report on Form 10-K for the fiscal
year ended December 31, 2019, Millendo’s Current Report on Form 8-K
filed on April 6, 2020 and 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.
Millendo Therapeutics, Inc. Condensed Statements of
Operations (Unaudited) (in thousands
except share and per share amounts)
Three Months Ended March 31,
2020
2019
Operating Expenses
Research and development
$
7,540
$
6,204
General and administrative
4,595
4,453
Loss from operations
12,135
10,657
Other (income) expense, net
(137
)
(291
)
Net loss
$
(11,998
)
$
(10,366
)
Net loss per share of common stock, basic and diluted
$
(0.65
)
$
(0.78
)
Weighted-average shares of common stock outstanding, basic and
diluted
18,448,507
13,357,999
Millendo Therapeutics, Inc.
Condensed Balance Sheet Data (Unaudited)
(in thousands) March 31,
December 31,
2020
2019
Cash, cash equivalents and restricted cash
$
58,877
$
63,512
Other assets
9,168
11,458
Total assets
$
68,045
$
74,970
Total liabilities
$
13,406
$
15,099
Total stockholders' equity
54,639
59,871
Total liabilities and stockholders' equity
$
68,045
$
74,970
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version on businesswire.com: https://www.businesswire.com/news/home/20200508005043/en/
Millendo Investors: Connie Chang Millendo Therapeutics
734-864-8006 chang@millendo.com
Millendo Media: Julie Bane MacDougall 617-821-1089
jbane@macbiocom.com
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