Ad hoc announcement pursuant to Art. 53 LR of the
SIX Swiss Exchange
GENEVA, Switzerland – February 24,
2023 – ObsEva SA (NASDAQ: OBSV; SIX:
OBSN), a biopharmaceutical company developing and
commercializing novel therapies for women’s health, today announced
a strategic reorganization that will consolidate operations in
Switzerland so as to preserve cash, focus resources towards the
development of nolasiban, a novel, oral oxytocin receptor agonist
to improve in vitro fertilization success rates, and manage its
out-licensed programs. As part of the reorganization, the Company
is downsizing its US-based Executive Management team and will
similarly propose a reduced Board of Directors at the next Annual
General Meeting. Additionally, ObsEva is retiring its convertible
debt, is expecting to be delisted from Nasdaq, and intends to
deregister from the US Securities and Exchange Commission (“SEC”),
while maintaining its current listing on SIX Swiss Exchange.
“On behalf of the Board of Directors, I extend
my sincere gratitude to Brian and the rest of the departing
executive team for their leadership and contributions to ObsEva,
and to all our departing employees for their efforts on behalf of
the Company,” said Annette Clancy, Chairwoman of the Board of
Directors. “The Board believes we are better positioned to deliver
shareholder value following these difficult reorganization
decisions. We look forward to strengthening the company by
continuing the clinical development of nolasiban and with the
future development of our out-licensed programs. We intend to
initiate a Phase 1b trial for nolasiban in the second half of 2023
as we remain committed to our mandate of improving women’s
health.”
Board of Directors and Management
ChangesIn connection with the reorganization, ObsEva’s
Chairwoman, Annette Clancy, and Board members Brian O’Callaghan,
Stephanie Brown, Anne VanLent, and Ed Mathers will not stand for
re-election at the Company’s upcoming annual general meeting of
shareholders. It is intended that ObsEva’s Founder, Dr. Ernest
Loumaye, will be nominated as Board Chairman along with the
nomination of Catarina Edfjäll as Board member.
Brian O’Callaghan stepped down as Chief
Executive Officer effective February 23, 2023, with Will Brown,
current Chief Financial Officer, appointed as Interim Chief
Executive Officer, while also retaining the title of Chief
Financial Officer. Additionally, Clive Bertram, Chief Commercial
Officer, Brandi Howard, Chief Clinical Officer, and Luigi Marro,
Chief Transformation Officer also departed the Company effective
February 23, 2023. The Company has initiated a search for a
permanent Chief Executive Officer to be based in Geneva,
Switzerland.
The reorganization is expected to provide annual
compensation savings of approximately $3.5 million.
Extinguishment of
Convertible DebtObsEva has also negotiated the early
retirement of $6.5 million in debt that represent amounts owed to
certain funds and accounts managed by JGB Management, Inc. (“JGB”)
pursuant to the Company’s Securities Purchase Agreement with
JGB.
Under the terms of the early retirement, ObsEva
and JGB agreed to apply $6.5 million previously held as collateral
in a control account against the outstanding convertible notes on a
pro rata basis, with JGB waiving a $1.1 million prepayment penalty
in exchange for approximately $566 thousand in cash and $250,000 in
the form of approximately 1.5 million common shares.
Delisting from the Nasdaq Capital
MarketObsEva has also notified The Nasdaq Stock Market LLC
(“Nasdaq”) of the Company’s inability to comply with Listing Rule
5450(a)(1) because the bid price of ObsEva’s common shares was not
at least $1.00 per share for ten consecutive business days since
receiving the non-compliance notice on September 12, 2022. ObsEva
had until March 13, 2023 to regain compliance with the minimum bid
price requirement. Upon delisting of ObsEva’s common shares from
the Nasdaq Capital Market, the Company intends to deregister with
the SEC to suspend its obligation to file periodic reports under
the Securities Exchange Act of 1934, as amended, including annual,
quarterly and current reports on Form 10-K, Form 10-Q and Form 8-K,
respectively, once certain conditions to deregistration are
satisfied, including the Company having fewer than 300 record
holders of its common shares. The Company expects the Nasdaq
delisting and SEC deregistration to contribute to lower general and
administrative costs in the future.
ObsEva intends to maintain its SIX Swiss
Exchange listing and to continue to trade under the ticker symbol
OBSN.
About NolasibanNolasiban is a
novel, oral oxytocin receptor antagonist being developed to improve
clinical pregnancy and live birth rates in women undergoing embryo
transfer following in vitro fertilization, a significant unmet
need.
ObsEva retains worldwide, exclusive, commercial
rights for nolasiban, except for the People’s Republic of China
where it has been sub-licensed to Yuyuan. Under the sublicense
agreement with Yuyuan for nolasiban, ObsEva is entitled to receive
aggregate milestone payments of up to $17 million upon the
achievement of specified development, regulatory, and first sales
milestones, and aggregate milestone payments of up to $115 million
upon the achievement of additional, tiered sales milestones. In
addition, Yuyuan has agreed to pay tiered royalties on net sales at
percentages ranging from high-single digit to low-double
digits.
About EbopiprantEbopiprant is
an investigational, orally active, selective prostaglandin F2α
(PGF2α) receptor antagonist being evaluated as a potential
treatment for preterm labor by reducing inflammation and uterine
contractions inlicensed from Merck KGaA. In July 2021, ObsEva
granted a license to Organon for the global development,
manufacturing, and commercial rights to Ebopiprant.
ObsEva sold and assigned all its rights to
Ebopiprant to XOMA Corporation (XOMA) in November 2022, including
the Company’s license agreements with Organon and Merck KGaA,
Darmstadt, Germany, and the intellectual property estate. The
Company received $15 million in upfront proceeds and is eligible to
receive up to $98 million upon the achievement of certain
development and regulatory milestones and sales milestones under
the license agreement with Organon.
About ObsEvaObsEva is a
biopharmaceutical company developing novel therapies to improve
women’s reproductive health and pregnancy. ObsEva has established a
development program focused on improving in vitro fertilization
success rates. ObsEva is listed on the Nasdaq Capital Market and is
traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange
where it is traded under the ticker symbol “OBSN”. For more
information, please visit www.ObsEva.com
Cautionary Note Regarding Forward
Looking Statements of ObsEva SA
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe”, “expect”, “may”, “plan”,
“potential”, “will”, and similar expressions, and are based on
ObsEva’s current beliefs and expectations. These forward-looking
statements include, without limitation, statements regarding
ObsEva’s plans for the future development of nolasiban; the plan to
downsize the Board of Directors; the expectations regarding
extinguishment of outstanding convertible debt with JGB, delisting
from Nasdaq and deregistration from the SEC; maintaining ObsEva’s
SIX listing and expectations regarding the impact of such strategic
decisions on ObsEva’s operations and financial condition. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include, without limitation, uncertainties
in ObsEva’s ability to successfully reorganize its
operations; ObsEva’s ability to recognize the anticipated
benefits of the reorganization, which may be affected by, among
other things, the ability of ObsEva to maintain relationships with
its partners and attract and retain management and key employees;
uncertainties in ObsEva’s ability to regain compliance
with the continued listing rules of Nasdaq and the effect
of a potential delisting from Nasdaq for ObsEva’s securities; the
ability of ObsEva to maintain its SIX listing; the expenses and
time that a delisting from Nasdaq and deregistration from the SEC
may require; inherent risks and uncertainties associated with the
conduct of clinical trials and clinical development, including the
risk that the results of earlier clinical trials may not be
predictive of the results of later stage clinical
trials; ObsEva’s reliance on third parties over which it
may not always have full control, and the capabilities of such
third parties; the impact of the ongoing novel coronavirus outbreak
and other economic or geopolitical events; and other risks and
uncertainties that are described in the Risk Factors section
of ObsEva’s Annual Report on Form 20-F for the year ended
December 31, 2021 filed with the SEC on March 10, 2022, in the
Reports on Form 6-K filed with the SEC on May 17,
2022, August 17, 2022 and December 1, 2022 and other
filings ObsEva makes with the SEC. These documents are available on
the Investors page of ObsEva’s website at http://www.ObsEva.com.
Any forward-looking statements speak only as of the date of this
press release and are based on information available to ObsEva as
of the date of this release, and ObsEva assumes no obligation to,
and does not intend to, update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
For further information, please
contact:
CEO Office contactShauna
Dillonshauna.dillon@obseva.ch+41 22 552 1550
Investor ContactWill
Brownwill.brown@obseva.com +1 (334) 313-2319
###
- ObsEva - PR - Strategic Reorganization_Feb 2023
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