-Linzagolix for uterine fibroids: Received confirmation of
positive CHMP opinion for marketing authorization application;
United States NDA PDUFA date in Q3:22-
-Linzagolix for endometriosis: Reported positive topline results
for linzagolix 200 mg with add-back therapy in the Phase 3
EDELWEISS 3 trial-
-Linzagolix franchise: Announced licensing agreement with
Theramex to support commercialization in Europe, in addition to
relationship with Syneos Health to support commercialization in the
United States-
Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss
Exchange
GENEVA,
Switzerland –
May
17,
2022 – ObsEva SA
(NASDAQ: OBSV)
(SIX: OBSN), a biopharmaceutical
company developing and commercializing novel therapies to improve
women’s reproductive health, today reported financial results for
the first quarter ended March 31, 2022 and provided a business
update.
“We are eagerly anticipating the approval of
linzagolix in Europe, which would mark our first product approval
and a major achievement for ObsEva,” said Brian O’Callaghan,
CEO of ObsEva. “With the potential to be, if approved, the first
and only approved GnRH antagonist with flexible dosing options with
and without hormonal add-back therapy, we believe linzagolix could
transform the standard of care for millions of women living with
uterine fibroids. In the United States, the regulatory review
process likewise remains on track, setting ObsEva up for multiple
potential approvals this year. We are advancing launch preparations
in both markets through our commercial agreements with Theramex and
Syneos Health to fully realize the significant commercial potential
of linzagolix, while continuing to evaluate strategic opportunities
in women’s health that could further enhance ObsEva’s value.”
Anticipated
Milestones
ObsEva anticipates the following key clinical
and regulatory objectives in 2022:
- Linzagolix for uterine
fibroids: Prescription Drug User Fee Act (PDUFA) target
action date of September 13, 2022, as set by the U.S. Food and Drug
Administration (FDA); European Commission approval expected
following confirmation in April of the Committee for Medicinal
Products for Human Use (CHMP) positive opinion for the marketing
authorization application (MAA).
- Linzagolix for
endometriosis: Additional data from the post-treatment
follow-up of the Phase 3 EDELWEISS 3 trial as well as data from the
long-term treatment in the extension study are expected in
mid-2022, and from the post-treatment follow-up of the extension
study in early
2023.
Pipeline Update
- Linzagolix for Uterine
Fibroids: ObsEva is developing linzagolix, an oral GnRH
receptor antagonist with potential best-in-class efficacy, a
favorable tolerability profile, and flexible dosing options for the
treatment of uterine fibroids. The CHMP of the European Medicines
Agency confirmed its positive opinion recommending approval of the
linzagolix MAA at the April 2022 CHMP meeting. The European
Commission is now reviewing the CHMP recommendation. If approved,
linzagolix will be the first and only approved oral GnRH antagonist
in uterine fibroids with a dosing option without additional
hormonal add-back therapy (ABT) to address the needs of women who
cannot or do not want to take hormones. In February 2022, ObsEva
announced a strategic licensing agreement with Theramex to support
the commercialization and market introduction of linzagolix across
global markets outside of the U.S., Canada and Asia, and EU launch
preparations are advancing. Theramex’s extensive women’s health
commercial infrastructure includes a dedicated sales force of more
than 180 experienced representatives across Europe, Brazil, and
Australia, alongside third-party distributors across approximately
60 countries. In the United States, the New Drug Application (NDA)
for linzagolix for uterine fibroids has been accepted for review by
the FDA, with a PDUFA target action date of September 13, 2022. In
October 2021, ObsEva announced a commercial sales agreement with
Syneos Health to commercialize linzagolix within the United States.
Syneos Health is a fully integrated biopharmaceutical solutions
organization with significant experience in women’s health
launches. ObsEva’s agreement with Syneos Health provides access to
a dedicated sales force, marketing, medical affairs professionals,
and market access in support of the linzagolix launch, if
approved.
At the American College of Obstetricians and
Gynecologists (ACOG) Annual Clinical and Scientific Meeting on May
6-8, additional data from the PRIMROSE Phase 3 studies of
linzagolix for uterine fibroids was featured in an oral
presentation and four posters. The analyses and post-treatment data
continue to underscore linzagolix’s clinical utility and
differentiated profile.
- Linzagolix for
Endometriosis: In January 2022, ObsEva announced positive
topline results from the Phase 3 EDELWEISS 3 trial in women with
moderate-to-severe endometriosis-associated pain. The 200 mg with
hormonal add-back therapy (ABT, estradiol 1mg/norethindrone 0.5mg)
dose met the co-primary efficacy objectives, demonstrating
reductions in dysmenorrhea (DYS) and non-menstrual pelvic pain
(NMPP) at 3 months. The 75 mg dose without hormonal ABT
demonstrated a statistically significant reduction versus placebo
in DYS at 3 months. Although the 75 mg dose without hormonal ABT
showed improvement in NMPP at 3 months, it did not reach
statistical significance versus placebo, and thus did not meet the
co-primary efficacy objective. Both doses were generally
well-tolerated and results support continued development of
linzagolix, including further exploration of dose options without
hormonal ABT. Additional efficacy results from the 6-month analysis
of the Phase 3 EDELWEISS 3 trial were announced in March 2022,
demonstrating rapid onset of treatment effect, positive impact on
quality of life, and intentions for surgery. Further data from the
post-treatment follow-up of the Phase 3 EDELWEISS 3 trial as well
as data from the long-term treatment in the extension study are
expected in mid-2022, and from the post-treatment follow-up of the
extension study in early 2023.
- Ebopiprant for Treatment of
Preterm Labor: In July 2021, ObsEva granted a license to
Organon (NYSE:OGN) for the global development, manufacturing and
commercial rights to ebopiprant. Ebopiprant 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. ObsEva
previously conducted clinical development through an ex-US Phase 2a
clinical trial, where reduced deliveries in singleton pregnancies
48 hours after the start of dosing were observed. Under the terms
of the agreement, ObsEva is entitled to receive tiered double-digit
royalties on commercial sales as well as up to $500 million in
upfront and milestone payments, including up to $90 million in
development and regulatory milestones. ObsEva is working closely
with Organon to discuss with the FDA the submission of an
Investigational New Drug Application for ebopiprant anticipated in
2022 to enable clinical development in the United States.
- Nolasiban for In Vitro
Fertilization: ObsEva is also advancing
nolasiban, an oral oxytocin receptor antagonist, to improve live
birth rates in women undergoing in vitro fertilization. ObsEva has
partnered with Yuyuan BioScience Technology for the development and
commercialization of nolasiban in China.
Leadership Transition
- Dr. Brandi
Howard was appointed as Chief Clinical Officer and member of the
company’s Executive Committee. Dr. Howard brings to ObsEva more
than 20 years of expertise in women’s health, with increasing
responsibilities in medical affairs strategy and leadership, as
well as leading large clinical development programs. Dr. Howard
succeeds Dr. Elizabeth Garner, who departed ObsEva on May 6, 2022
to pursue a new opportunity. To help ensure a smooth transition,
Dr. Garner has agreed to provide advisory consulting services to
ObsEva on an as needed basis.
Financial Results for
the First Quarter Ended
March 31,
2022
- ObsEva had cash
and cash equivalents of $57.6 million at March 31,
2022 compared to $54.7 million at December 31,
2021. The increase of $2.8 million is primarily
attributable to $5.7 million of net cash received during
the first quarter 2022 from the utilization of its at-the-market
offering program, $8.3 million in proceeds from the Company’s
securities purchase agreement with certain funds and accounts
managed by JGB Management, Inc. (JGB), a $5.7 million upfront
payment in connection with the Company’s licensing agreement with
Theramex, offset by cash used for operating activities.
- Operating income
other than revenue was $2.2 million for the quarter
ended March 31, 2022 compared to $6,000 in the
prior year period. The increase was due to the partial recognition
of the upfront payment associated with the Company’s licensing
agreement with Theramex, net of fees and recognition of the
associated intangible asset.
- Research and
development expenses were $5.6 million for the quarter
ended March 31, 2022, compared to $15.5 million in
the prior year period, representing a decrease of $9.9
million. The decrease was primarily due to decreased costs related
to the development of linzagolix due to the timing of clinical
trial activities.
- General and
administrative expenses were $7.2 million for the quarter
ended March 31, 2022 compared to $4.2
million in the prior year period, an increase of $3.0
million. The increase was attributable to professional fees
associated with commercial launch preparation, insurance, and
additional employee compensation costs; partially offset by lower
legal fees.
- Finance result,
net was $1.1 million for the quarter ended March 31,
2022, compared to $0.3 million for the prior year period.
The increased expense was primarily due to higher interest costs
related to ObsEva’s borrowings under its securities purchase
agreement with JGB.
- Net loss for the
quarter ended March 31, 2022 was $11.8 million,
or $0.14 net loss per share, compared to $20.0
million in the prior year period, or $0.29 net loss
per share. The difference in net loss was primarily attributable to
the recognition of the upfront payment in connection with the
Company’s licensing agreement with Theramex and lower research and
development expenses, offset by higher general and administrative
expenses.
The first quarter 2022 financial statements can
be accessed in the financial reports section of the Company’s
website, or directly here.
Webcast and Conference Call ObsEva will
host a conference call and webcast today at 8:00 a.m. Eastern
time, 2:00 p.m. Central European Time. Individuals may participate
via telephone by dialing (877) 300-8521 (domestic) or +1 (412)
317-6026 (international) and using conference ID 10166576. The
webcast can be accessed live here and will also be
accessible under “Events Calendar” in the investors section of
ObsEva’s website. The webcast will be archived on the
company’s website for at least 30 days after the conference
call.
About ObsEva
ObsEva is a biopharmaceutical company developing
and commercializing novel therapies to improve women’s health.
Through strategic in-licensing and disciplined drug development,
ObsEva has established a late-stage clinical pipeline with
development programs focused on new therapies for the treatment of
uterine fibroids, endometriosis, and preterm labor. ObsEva is
listed on the Nasdaq Global Select 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
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 “anticipate”, “believe”, “continue”,
“could”, “estimate”, “expect”, “intend”, “may”, “might”, “ongoing”,
“objective”, “plan”, “potential”, “predict”, “should”, “will”,
“would”, or the negative of these and similar expressions, and are
based on ObsEva’s current beliefs and expectations. These
forward-looking statements include expectations regarding the
potential approval of linzagolix by regulatory authorities,
including the European Commission and the FDA, and the timing of
such approval and subsequent transition of ObsEva to a
commercial-stage company, the timing or results of interactions
with regulatory authorities, the commercialization of linzagolix
across global markets, expected timing of the European Commission’s
decision and the FDA target action date for linzagolix, clinical
development of ObsEva’s product candidates, including the timing,
advancement of, and potential therapeutic benefits of such product
candidates, regulatory and development milestones, including the
anticipated milestones and pipeline updates, the potential for such
product candidates to be commercially competitive and the success
of the Company’s partnerships with third parties. 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 uncertainties inherent in 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, related interactions with
regulators, including interactions with the European Medicines
Agency during the marketing authorization application process and
with the FDA during the NDA process for linzagolix, 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 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 Securities and Exchange
Commission (SEC) on March 10, 2022, and other filings ObsEva makes
with the SEC. These documents are available on the Investors page
of ObsEva’s website at 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, except as required by law, 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 Contact:Shauna
DillonShauna.dillon@obseva.ch+41 22 552 1550
Investor
Contact:Katja
BührerKatja.buhrer@obseva.com+1 (917) 969-3438
Consolidated Statements of Comprehensive
Loss
(in USD ’000, except per
share data) |
|
|
Three-month periodended
March 31, |
|
|
|
|
2022 |
|
|
2021 |
|
Operating income other
than revenue |
|
|
|
2,237 |
|
|
|
6 |
|
OPERATING
EXPENSES |
|
|
|
|
|
|
|
|
|
Research and development
expenses |
|
|
|
(5,608 |
) |
|
|
(15,516 |
) |
General and administrative
expenses |
|
|
|
(7,233 |
) |
|
|
(4,191 |
) |
Total operating
expenses |
|
|
|
(12,841 |
) |
|
|
(19,707 |
) |
OPERATING
LOSS |
|
|
|
(10,604 |
) |
|
|
(19,701 |
) |
Finance income |
|
|
|
1,933 |
|
|
|
629 |
|
Finance expense |
|
|
|
(3,077 |
) |
|
|
(911 |
) |
NET LOSS BEFORE
TAX |
|
|
|
(11,748 |
) |
|
|
(19,983 |
) |
Income tax expense |
|
|
|
(53 |
) |
|
|
(21 |
) |
NET LOSS FOR THE
PERIOD |
|
|
|
(11,801 |
) |
|
|
(20,004 |
) |
Net loss per
share |
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
(0.14 |
) |
|
|
(0.29 |
) |
Diluted |
|
|
|
(0.14 |
) |
|
|
(0.29 |
) |
TOTAL OTHER COMPREHENSIVE
INCOME / (LOSS) |
|
|
|
— |
|
|
|
— |
|
TOTAL COMPREHENSIVE LOSS
FOR THE PERIOD |
|
|
|
(11,801 |
) |
|
|
(20,004 |
) |
Consolidated Balance Sheets
(in USD
’000) |
|
|
March 31,2022 |
|
|
December 31,2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
57,553 |
|
|
|
54,734 |
|
Other receivables |
|
|
|
953 |
|
|
|
3,560 |
|
Prepaid expenses |
|
|
|
5,756 |
|
|
|
5,223 |
|
Total current
assets |
|
|
|
64,262 |
|
|
|
63,517 |
|
Non-current
assets |
|
|
|
|
|
|
|
|
|
Right-of-use assets |
|
|
|
521 |
|
|
|
625 |
|
Furniture, fixtures and
equipment |
|
|
|
63 |
|
|
|
58 |
|
Intangible assets |
|
|
|
23,903 |
|
|
|
24,503 |
|
Other long-term assets |
|
|
|
395 |
|
|
|
288 |
|
Total non-current
assets |
|
|
|
24,882 |
|
|
|
25,474 |
|
Total
assets |
|
|
|
89,144 |
|
|
|
88,991 |
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
|
Other payables and current
liabilities |
|
|
|
4,734 |
|
|
|
9,038 |
|
Accrued expenses |
|
|
|
15,421 |
|
|
|
13,783 |
|
Current lease liabilities |
|
|
|
624 |
|
|
|
686 |
|
Total current
liabilities |
|
|
|
20,779 |
|
|
|
23,507 |
|
Non-current
liabilities |
|
|
|
|
|
|
|
|
|
Non-current lease
liabilities |
|
|
|
119 |
|
|
|
240 |
|
Non-current borrowings |
|
|
|
33,134 |
|
|
|
25,733 |
|
Post-employment obligations |
|
|
|
6,563 |
|
|
|
6,581 |
|
Other long-term liabilities |
|
|
|
584 |
|
|
|
591 |
|
Total non-current
liabilities |
|
|
|
40,400 |
|
|
|
33,145 |
|
Shareholders’
equity |
|
|
|
|
|
|
|
|
|
Share capital |
|
|
|
6,812 |
|
|
|
6,489 |
|
Share premium |
|
|
|
436,694 |
|
|
|
430,630 |
|
Reserves |
|
|
|
33,236 |
|
|
|
32,195 |
|
Accumulated losses |
|
|
|
(448,777 |
) |
|
|
(436,975 |
) |
Total shareholders’
equity |
|
|
|
27,965 |
|
|
|
32,339 |
|
Total liabilities and
shareholders’ equity |
|
|
|
89,144 |
|
|
|
88,991 |
|
###
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