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ObsEva SA is a biopharmaceutical company based in Plan-les-Ouates, Switzerland, specializing in the development and commercialization of novel therapies to enhance women's reproductive and pregnancy health. Founded in 2012, ObsEva is dedicated to addressing unmet needs in reproductive medicine by focusing on innovative treatments that aim to improve fertility outcomes and manage preterm labor.
Currently, ObsEva is involved in several key projects, including their lead product linzagolix, an oral GnRH antagonist designed to treat uterine fibroids and endometriosis. This medication aims to offer significant benefits over existing treatments by providing symptom relief with fewer side effects.
ObsEva's approach is underscored by a robust pipeline and strategic partnerships with leading healthcare organizations. Financially, the company continues to navigate its path with a focus on securing funding to propel its clinical trials and regulatory submissions. Recently, ObsEva has made significant strides with positive results from their Phase 3 trials for linzagolix, putting them on track for potential market approval.
ObsEva's commitment to innovation and patient health is reflected through its continuous efforts in research and development, making significant progress in areas with high medical needs. The company's forward-looking strategy is built on scientific rigor, collaborative partnerships, and a deep understanding of women's health issues.
For more information, please contact:
General inquiries: contact@obseva.ch
Investor relations: IR@obseva.ch
ObsEva SA
Chemin des Aulx 12,
1228 Plan-les-Ouates,
Switzerland
ObsEva SA (NASDAQ: OBSV) reported financial results for Q3 2022, showcasing a significant shift due to a restructuring process that generated capital and streamlined its cost structure. The company raised $15 million from selling Ebopiprant rights to XOMA, aimed at resolving over-indebtedness and regaining compliance with Nasdaq listing requirements. Research and development expenses plummeted to $0.7 million from $11.5 million in the previous year, aided by a workforce reduction of approximately 70%. However, the net loss reached $12.1 million, compared to a net income of $0.8 million in the prior year.
ObsEva has sold its rights to Ebopiprant to XOMA for an upfront payment of $15 million and potential future milestone payments up to $98 million. This transaction aims to resolve ObsEva's over-indebtedness and withdraw its pending moratorium in Switzerland. The sale proceeds are expected to help the company regain compliance with Nasdaq's minimum stockholders' equity requirement, providing over a year of cash runway for strategic initiatives, particularly focusing on nolasiban, a treatment for improving pregnancy rates in IVF.
ObsEva SA (NASDAQ: OBSV) announced substantial completion of the linzagolix program transition to Kissei Pharmaceutical, saving approximately $16.0 million in contract commitments, including $3.7 million in assigned accounts payable. The company extended a forbearance agreement with JGB until December 1, 2022, lowering the conversion price of certain debts, now totaling $6.7 million. A Swiss court has granted a stay of moratorium proceedings until November 30, 2022. ObsEva aims to refocus resources on developing nolasiban, with a Phase 1 trial in China approaching.
ObsEva SA (NASDAQ: OBSV; SIX: OBSN) announced the approval of Yuyuan Bioscience's IND application for a Phase 1 clinical trial of nolasiban by China's National Medical Products Administration. Nolasiban, an oral oxytocin receptor antagonist, aims to enhance clinical pregnancy rates in women undergoing IVF. The trial will evaluate the safety and pharmacokinetics in healthy females. ObsEva has sublicensed rights to Yuyuan, with potential milestone payments of up to $132 million and royalties on net sales, reinforcing ObsEva's commitment to women's reproductive health.
ObsEva SA (NASDAQ: OBSV) announced significant restructuring efforts, including a reduction-in-force impacting 70% of employees, expected to save $7.6 million annually. The company is also reassigning $6.2 million in linzagolix program contracts to Kissei Pharmaceutical. Furthermore, ObsEva is working to regain compliance with Nasdaq’s minimum stockholders’ equity and bid price rules after receiving notifications of noncompliance. The company aims to enhance its focus on advancing licensing agreements for its fertility drug nolasiban as part of these restructuring efforts.
ObsEva SA (NASDAQ: OBSV) announced it received a notification from Nasdaq on August 19, 2022, indicating non-compliance with Listing Rule 5450(b)(1)(A) due to insufficient stockholders' equity, reported at ($2,103,000) as of June 30, 2022. Nasdaq has given ObsEva until August 29, 2022, to submit a compliance plan. If accepted, the company may receive an extension of up to 180 days to rectify the issue. The notification does not immediately affect trading, which continues on Nasdaq under the symbol OBSV.
ObsEva SA (NASDAQ: OBSV), a biopharmaceutical company, released its Second Quarter 2022 Financial Statements on August 17, 2022. The report highlights their ongoing commitment to developing therapies for women’s reproductive health, particularly focusing on preterm labor and IVF-related treatments. For further details, the financial statements are accessible on their website. ObsEva continues to pursue strategic in-licensing to enhance its clinical pipeline and improve pregnancy outcomes.
ObsEva SA (NASDAQ: OBSV) announced the early retirement of $31 million in debt owed to JGB Management, part of its Securities Purchase Agreement. The company will use cash held as collateral to retire the debt and has negotiated a forbearance agreement with JGB, which waives a 25% prepayment penalty. The outstanding convertible notes now total approximately $11 million, with the conversion price set at $0.26 per share. This restructuring aims to assist ObsEva's operations and potential court-sanctioned moratorium for its planned restructuring.
ObsEva SA announced that Jean-Pierre Gotteland, Chief Scientific Officer, is resigning effective September 30, 2022. His departure from the Executive Committee is immediate. The Board expressed gratitude for his seven years of service. ObsEva focuses on developing therapies for women’s reproductive health, including treatments for preterm labor and IVF success rates. The company operates under the ticker OBSV on Nasdaq and OBSN on the SIX Swiss Exchange.
ObsEva SA (NASDAQ: OBSV) announced significant corporate restructuring due to issues raised by the FDA regarding its New Drug Application for linzagolix. The company plans to terminate its license agreement with Kissei and apply for a court-sanctioned moratorium in Switzerland to aid restructuring. This decision aims to manage ongoing development costs amid potential delays in FDA approval. Despite challenges, ObsEva will continue to support existing partnerships, including agreements with Organon for ebopiprant and Yuyuan BioScience for nolasiban.
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