GlobeNewswire by notified

ObsEva Hosts Symposium and Presents Clinical Data on Oral GnRH Antagonist Linzagolix at SEUD Congress 2021

Share

-Symposium on oral GnRH antagonists and personalized therapeutic approaches for women with uterine fibroids to be hosted Friday, December 10 at 1 p.m. CET-

-52-Week Data from the Phase 3 PRIMROSE studies of linzagolix for the treatment of uterine fibroids demonstrating sustained safety and efficacy results at 52weeks to be presented orally-

-Long-term follow-up data from Phase 2bEDELWEISS study of linzagolix for the treatment of endometriosis demonstratingbone mineral density recovery to be presented orally-

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

GENEVA, Switzerland December10, 2021 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced upcoming presentations of its linzagolix clinical development program at the 7th Society of Endometriosis and Uterine Disorders (SEUD) Congress being held virtually and in Stockholm, Sweden as a hybrid event from December 9-11, 2021. ObsEva will also be hosting a symposium on Friday, December 10, 2021, at 1 p.m. CET, which will highlight the importance of more personalized therapeutic approaches and the potential of oral GnRH antagonists in uterine fibroid management.

“The encouraging data presented at SEUD highlights the differentiated therapeutic potential of linzagolix, which, if approved, would be the only GnRH antagonist that would provide flexible dosing options to better address the individual needs of women with uterine fibroids,” said Jacques Donnez, M.D., Ph.D., a key opinion leader in gynecologic therapeutics. “We are encouraged by the sustained results observed at 24-weeks and 52-weeks at both high and low doses of linzagolix, as well as with and without hormonal add-back therapy. The bone-mineral-density (BMD) changes in this patient population are consistent with the dose-dependent suppression of serum estradiol as well as the presence of hormonal add-back therapy. In the endometriosis indication, the long-term results from the Phase 2b study showing BMD recovery are encouraging. Together, these results build upon a compelling foundation that underscores, if approved, the potential clinical utility of linzagolix and the opportunity to offer unique dosing options that could balance efficacy and safety across indications.”

Details on the data presentations are provided below.

Linzagolix for the Treatment of Uterine Fibroids

The presentation titled “Long Term Efficacy of Linzagolix for Treatment of Heavy Menstrual Bleeding (HMB) due to Uterine Fibroids (UF): 52-Week Results from Two Placebo-Controlled, Randomized, Phase 3 Trials,” is being presented by Dr. Hugh Taylor.

Summary of the data and key takeaway: Once daily doses of linzagolix 100 and 200 mg with and without ABT improved heavy menstrual bleeding (HMB) and other symptoms of uterine fibroids, including pain and Quality of Life, compared to placebo at 24 weeks and these improvements were maintained at 52 weeks.
HMB: Reductions observed at 24 weeks in all active treatment groups compared to placebo (p≤0.003).
Responder rates for menstrual blood loss (MBL):

Placebo100 mg100 mg +ABT200 mg 200 mg + ABT
MBL P1 at 24 weeks35%56%67%71%75%
MBL P2 at 24 weeks29%57%77%78%94%
MBL P1 at 52 weeks39%61%91%76%86%
MBL P2 at 52 weeksNA53%91%85%92%

Mean pain scores at 52 weeks: Reductions in mean pain scores of 2-4 were observed in all linzagolix groups compared to <1 in the placebo groups (p≤0.002).
Uterine volume at 52 weeks: Uterine volume was substantially decreased at 24 weeks by approximately 40% in the linzagolix 200 mg without ABT group but not in the other groups. Furthermore, after the addition of ABT in this group, uterine volumes increased again by 52 weeks.

The presentation titled “Long Term Safety and Tolerability of Linzagolix for Treatment of Heavy Menstrual Bleeding (HMB) due to Uterine Fibroids (UF): 52-Week Results from Two Placebo-Controlled, Randomized, Phase 3 Trials,” is being presented by Dr. Jacques Donnez.

Summary of the data and key takeaway: Effects on safety and tolerability including hot flushes, BMD changes, serum lipid and liver transaminase increases, were consistent with the dose dependent suppression of serum estradiol and the presence or not of hormonal ABT.
Serum estradiol: Levels were suppressed below 20 pg/mL in the linzagolix 200 mg without ABT group and maintained between 20-60 pg/mL in the other linzagolix groups.

Meanlumbar spine percent BMD change from baseline: At 24 weeks BMD change ranged from 0–2% in all active treatment groups except 200 mg linzagolix (3–4%). At 52 weeks BMD change was 3.6% in P1 and 2.4% in P2 with linzagolix 100 mg; 1.3 in P1 and 2.0% in P2 with linzagolix 200 mg + ABT compared to 2.3% with placebo (P1 only).
Lipids andliver transaminases: There were minor elevations in lipids and rare increases in liver transaminases in the linzagolix groups; no specific signal for potential of drug-induced liver injury was identified.

Adverse Events (AE): The most common AE up to 52 weeks, were hot flushes, which was reported in 22% of subjects in the 200mg group and between 6% to 12% in the other linzagolix arms, compared to 8% in placebo subjects.

Linzagolix for the Treatment of Endometriosis

The presentation titled “Recovery of Bone Mineral Density (BMD) after Long Term Treatment with Linzagolix in Women with Endometriosis: Results from a Phase 2b Dose-Ranging Trial,” is being presented by Dr. Jacques Donnez.

Summary of the data and key takeaway: Subjects remained within the age normalized range during and after treatment. Bone safety was demonstrated in the vast majority of subjects across all doses of linzagolix.

Mean lumbar spine percent BMD change from baseline: Once daily linzagolix for 52 weeks in patients with endometriosis was associated with dose-dependent changes in bone mineral density (BMD) of the lumbar spine at doses of 75 mg and above. Mean changes ranged from about -1% at 75mg to more than -2% at 200/100 mg and were reversed 6 months after stopping treatment.

50 mg75 mg100 mg200 mg
BMD at 24 weeks0.14%-0.8%-1.4%-2.6%
BMD at 52 weeks0.14%-1.1%-1.4%-2.2%
BMD after 6 months1.3%1.2%0.2%0%

At 52 weeks, the proportion of subjects with a BMD decrease >3% was 50% in the high dose group and <20% in the low dose groups (75 and 100 mg) and no subjects in any group had a BMD decrease >8%.

About Linzagolix

Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile1,2,3. Linzagolix is the subject of submitted marketing authorization applications for the treatment of heavy menstrual bleeding associated with uterine fibroids and is currently in late-stage clinical development for the treatment of pain associated with endometriosis. Obseva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.

About the Phase 3 PRIMROSE Program in Uterine Fibroids

PRIMROSE 1 & 2 were prospective, randomized, parallel group, double-blind, placebo-controlled Phase 3 studies that investigated the efficacy and safety of two dosing regimens of linzagolix, 100 mg and 200 mg once daily, alone and in combination with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate) for the treatment of heavy menstrual bleeding associated with uterine fibroids. PRIMROSE 1 was conducted in the United States and enrolled 574 women. PRIMROSE 2 was conducted in Europe and the United States and enrolled 535 women. Both trials comprised a 52-week treatment period followed by a 6-month post treatment follow-up period. Additional information can be found here. The primary efficacy endpoint was reduced MBL at 24 weeks (MBL ≤ 80 mL and ≥ 50% reduction from baseline). Other efficacy assessments included amenorrhea, hemoglobin, pain (0–10 numerical rating scale), uterine and fibroid volume, and quality of life. For additional information on this trial see clinicaltrials.gov [NCT03070899, NCT03070951]

About EDELWEISS

EDELWEISS, a Phase 2b, randomized, double blind, placebo controlled clinical trial was designed to evaluate the safety and efficacy of multiple doses of linzagolix in 327 women with moderate-to-severe endometriosis-associated pain. Patients were randomized to receive either an oral once daily dose of linzagolix (50mg, 75mg, 100mg or 200mg) or placebo for up 12 weeks. Subjects originally randomized to placebo were switched to 100mg at 12 weeks and subjects randomized to 200mg were switched to 100mg at 24 weeks. Bone mineral density (BMD) was assessed using Dual Energy X-ray Absorptiometry (DXA) at baseline, after 24 and 52 weeks of treatment and 24 after stopping treatment. For additional information on this trial see clinicaltrials.gov [NCT02778399].

About Obseva

Obseva is a biopharmaceutical company built to address some of the most challenging unmet needs in women’s health – an under-researched, under-invested field of medicine. With deep expertise in clinical development, Obseva is passionate about the pursuit of advances that benefit women and their health and the importance of delivering truly meaningful innovation in this space. 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.

About Kissei

Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D.

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 “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Obseva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development and potential therapeutic and clinical benefits of and commercialization plans for Obseva’s product candidates, including linzagolix, expectations regarding regulatory and development milestones, including the Obseva’s ability to obtain and maintain regulatory approvals for its product candidates, and the results of interactions with regulatory authorities, including the FDA and EMA. 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 that FDA’s review of the linzagolix NDA may determine that the existing clinical data is insufficient to support approval or that significant labeling limitations would be required, 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, 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 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, 2020 filed with Securities and Exchange Commission (SEC) on March 5, 2021 and in the Report on Form 6-K filed with the SEC on November 4, 2021, 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 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 Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

Investor Contact
Joyce Allaire
jallaire@lifesciadvisors.com
+1 (617) 435-6602

1. Stewart E, ASRM 2020; Late-breaker abstract P-930
2. Al-Hendy A, NEJM 2021; 384:630-42
3. Schlaff W, NEJM 2020; 382:328-40

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Idorsia expands its commercialization partnership with Syneos Health for daridorexant in Europe and Canada26.1.2022 07:00:00 CET | Press release

Idorsia expands its commercialization partnership with Syneos Health for daridorexant in Europe and Canada Idorsia to capitalize upon the unique opportunity to transform the insomnia treatment paradigm, notably in Europe where daridorexant would be the first dual orexin receptor antagonist made available to patients with insomniaCollaboration with Syneos Health to effectively reach the primary care market in Europe and Canada Allschwil, Switzerland& Morrisville, N.C. – January26, 2022 Idorsia Ltd (SIX: IDIA), a leading Swiss biopharmaceutical company, and Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, today announced the extension of an existing collaboration to commercialize daridorexant, a novel dual orexin receptor antagonist for the treatment of insomnia across Europe and Canada. Simon Jose, Chief Commercial Officer of Idorsia, commented: “Daridorexant represents a significant advance in the treatment of insomnia, and it is now our

Sharing of Staking Rewards Announcement26.1.2022 07:00:00 CET | Press release

January 26th 2022 CoinShares Digital Securities Limited CoinShares Physical Staked Tezos CoinShares Physical Staked Polkadot Sharing of Staking Rewards CoinShares Digital Securities Limited (the “Issuer”) hereby announces in accordance with Condition 5.3.2 of the Conditions of the CoinShares Digital Securities that Staking Rewards in relation to the class (the “Specified Class”) specified below will be applied by a reduction in the Management Fee applicable to the Specified Class to zero and a positive daily accrual to the Coin Entitlement to the Specified Class provided in the table below . Such reduction to the Management Fee and positive daily accrual to the Coin Entitlement shall apply from the start of trading on January 26th, 2022 until a date to be specified in a further announcement in accordance with Condition 5.3.2. ClassISINManagement FeeStaking Reward (positive daily accrual to Coin Entitlement) CoinShares Physical Staked Tezos GB00BMWB4803 Reduced to 0.0% p.a. 3.00% p.a. C

Aino Health AB (publ): Norberg & Partner Sustainable Group AB (publ) tecknar aktier i Aino Health AB (publ).25.1.2022 19:45:00 CET | Pressemelding

Detta pressmeddelande utgör inte ett offentligt uppköpserbjudande eller annars ett erbjudande om att förvärva aktier. Norberg & Partner Sustainable Group AB (publ)tecknar aktier i Aino Health AB (publ) och utlöser därmed budplikt. Norberg & Partner Sustainable Group AB (publ), org.nr 559268-0663 (”Norberg & Partner”) har idag tecknat 15 384 616 aktier i Aino Health AB (publ), org.nr 559063-5073 (”Aino Health”) till ett pris om 0,65 kronor per aktie. Efter förvärvet äger Norberg & Partner cirka 36,38 procent av aktierna och rösterna i Aino Health. Genom förvärvet utlöses budplikt, vilket innebär att Norberg & Partner är skyldig att offentliggöra ett budpliktsbud avseende resterande aktier i Aino Health inom fyra veckor från förvärvet, alternativt avyttra så många aktier så att aktieinnehavet representerar mindre än tre tiondelar av röstetalet för samtliga aktier i Aino Health. För ytterligare information, se Norberg & Partners hemsida. www.norbergpartner.se/ Kontaktperson: Jyrki Eklund,

Sword Group: 2021 Fourth Quarterly Results | Exceptional Profitability25.1.2022 19:15:00 CET | Press release

2021 Fourth Quarterly Results Consolidated Revenue: €59.7m Consolidated Growth: +31.8% Organic Growth: +21.9% EBITDA Margin: 15.0% RESULTS 4TH QUARTER 2021 Q4 (1) €m 2021 2020 Revenue 59.7 45.3 EBITDA 9.0 7.6 EBITDA Margin 15.0% 13.0% (1) non audited figures Organic growth on a like-for-like basis and at constant exchange rates: +21.9%. YEAR 2021 Consolidated Revenue: €214.6m Organic Growth: +21.5% EBITDA Margin: 13.6% ANALYSIS The Revenue for the Fourth Quarter of 2021 amounts to €59.7m in consolidated terms and to €55.2m without taking into account the acquisition of AiM, added to the perimeter on 1 July 2021. The EBITDA margin for the quarter amounts to 15.0% and organic growth to +21.9%. For 2021, the consolidated revenue amounts to €214.6m with an EBITDA margin of 13.6%. Organic growth for the year amounts to +21.5%. The Group established its 2021 Business Plan based on an organic growth hypothesis of 13%. Sword outperformed in terms of growth while maintaining and even exceeding

Aino Health AB (publ): The board of Aino Health resolves on a directed issue of shares to Norberg & Partner Sustainable Group AB (publ).25.1.2022 19:00:00 CET | Press release

This document in English is a translation of the original in Swedish. In case of any discrepancy, the Swedish original will prevail. The board of Aino Health AB (publ), reg. number 559063-5073 (the “Company”) has today, based on the authorisationfrom the annual general meeting on 24th of May 2021, resolved on a directed issue of 15 384 616 shares with deviation from the shareholders’ pre-emption right.The issue is directed to Norberg & Partner Sustainable Group AB (publ) (”Norberg & Partner”) in order to secure the Company’s long-term financing in a time-and cost-efficient manner and entails an estimated capital injection of approximately SEK 10 million. The subscription price was, after negotiations with the subscriber, determined to SEK 0.65 per new share, which corresponds to the market value as assessed by the board. The reason for the deviation from the shareholders’ pre-emptive right is to secure the Company’s long-term financing in a time- and cost-efficient manner. The new shar

Aino Health AB (publ): Styrelsen i Aino Health AB (publ) beslutar om en riktad nyemission till Norberg & Partner Sustainable Group AB (publ).25.1.2022 19:00:00 CET | Pressemelding

Styrelsen i Aino Health AB (publ), org.nr 559063-5073 (”Bolaget”) har, med stöd av bemyndigandet från årsstämman den 24 maj 2021, idag beslutat att genomföra en riktad nyemission av 15 384616 aktier med avvikelse från aktieägarnas företrädesrätt. Nyemissionen är riktad till Norberg & Partner Sustainable Group AB (publ) (”Norberg & Partner”) i syfte att säkra Bolagets långsiktiga finansiering och medför ett förväntat kapitaltillskott om ca 10 miljoner kronor. Teckningskursen har efter förhandling med teckningsberättigade fastställts till 0,65 kronor per aktie, vilket motsvarar av styrelsen bedömt marknadsvärde. Skälet till avvikelsen från aktieägarnas företrädesrätt är att emissionslikviden ska användas i syfte att på ett snabbt och kostnadseffektivt sätt stärka Bolagets långsiktiga finansiering. Betalning för de nyemitterade aktierna sker genom kontant betalning. Antalet aktier i Bolaget ökar med 15 384 616 aktier, från 26 901 155 aktier till 42 285 771 aktier. Aktiekapitalet i Bolaget

EXTRAORDINARY GENERAL MEETING APPROVES INCREASE OF CONDITIONAL CAPITAL AND SIKA PROPOSES ELECTION OF GORDANA LANDEN TO THE BOARD OF DIRECTORS25.1.2022 18:00:00 CET | Press release

EXTRAORDINARY GENERAL MEETING APPROVES INCREASE OF CONDITIONAL CAPITAL AND SIKA PROPOSES ELECTION OF GORDANA LANDEN TO THE BOARD OF DIRECTORS At an Extraordinary General Meeting, Sika’s shareholders approved the increase of conditional capital. Sika recommends the election of Gordana Landento the Board of Directors at the next Annual General Meeting, to be held on April 12, 2022. On January 25, 2022, an Extraordinary General Meeting of Sika AG was held. Based on Ordinance 3 of the Federal Council on measures to prevent the spread of COVID-19, it was not possible for shareholders to physically attend the Extraordinary General Meeting. Instead, shareholders cast their votes through the independent proxy. The shareholders approved an increase to the existing conditional capital from CHF 155,893.20 (corresponding to 15,589,320 registered shares with a par value of CHF 0.01 each) to CHF 187,893.20 (corresponding to 18,789,320 registered shares with a par value of CHF 0.01 each). Shareholder