UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of May 2022
Commission File Number: 001-37993
OBSEVA SA
(Translation of registrants name into English)
Chemin des Aulx, 12
1228 Plan-les-Ouates
Geneva, Switzerland
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
This Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3, as amended (No. 333-221462, 333-233069, 333-260974 and 333-262820) of ObsEva SA (including any prospectuses forming a part of such registration statements) and the registration statements on Form S-8 (Registration No. 333-216170, 333-231629, 333-249457 and 333-263234) of ObsEva SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ObsEva SA | ||||||
Date: May 2, 2022 | By: | /s/ Brian OCallaghan | ||||
Name | Brian OCallaghan | |||||
Title: | Chief Executive Officer |
Exhibit 99.1
ObsEva Announces Appointment of Dr. Brandi Howard as Chief Clinical Officer
Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange
GENEVA, Switzerland May 2, 2022 ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for womens health, today announced the appointment of Dr. Brandi Howard as Chief Clinical Officer and member of the companys Executive Committee, effective May 9, 2022. Dr. Howard, who brings to ObsEva more than 20 years of womens health expertise, will be responsible for the Companys clinical development and medical affairs strategy. She succeeds Dr. Elizabeth Garner, who will be departing the Company 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.
We are pleased to welcome Brandi, a recognized expert in womens health, at this promising time for ObsEva as we anticipate our first product approvals in 2022 and further advancement of our attractive pipeline, said Brian OCallaghan, CEO of ObsEva. Brandi is the clear and unanimous choice of the Board and executive team to serve as our Chief Clinical Officer, given her demonstrated success leading clinical development programs, medical affairs organizations, new product launches, and regulatory processes. We wish Beth well in her future endeavors. I know I speak on behalf of all our employees when I say that it has been an honor and pleasure to work together, and I am very pleased that Beth will remain a key part of ObsEvas future success as an advisor to the Company.
Dr. Howard has deep womens health expertise with increasing responsibilities in medical affairs strategy and leadership, as well as leading large clinical development programs. She was previously Head of Medical and Clinical Affairs at Evofem Biosciences (NASDAQ: EVFM) since 2016 where she led the clinical program for the FDA approval of Phexxi®, as well as the creation of the medical affairs organization in support of the launch. Dr. Howard was also responsible for driving the successful Phase 2b/3 study for additional indications and the current Phase 3 confirmatory trial. Prior to joining Evofem, she spent eight years in various roles at Teva Pharmaceuticals (NYSE: TEVA) in Global and U.S. medical affairs, including as Head of U.S. Field Medical Affairs directing over 100 medical affairs professionals across eight therapeutic areas and the U.S. Medical Director for Womens Health. Dr. Howard has also been actively involved in investor relations and business development activities in prior roles. Her Ph.D. research at the University of Pennsylvania focused on adolescent sexual behaviors and contraceptive use. She earned her Bachelor of Science, Nursing, from the Medical College of Georgia and her Master of Science, Womens Health and Perinatology, from Georgia State University.
Dr. Howard commented: Its an exciting time to be joining ObsEva, with the expected approval of linzagolix for uterine fibroids in Europe and the United States in the next six months and subsequent transition to a commercial-stage company. With a talented team and promising pipeline in place, ObsEva is strongly positioned to address the most challenging unmet needs facing women and bring much needed innovation to the field. I look forward to building on the momentum created by Beth and the team to date, and being part of ObsEvas next phase of growth.
Dr. Garner added: It has been a privilege to work with the remarkably talented and driven team at ObsEva. Brandi and I have had a close professional relationship for a number of years, and I believe she is ideally suited to lead the clinical development and medical affairs strategy at ObsEva going forward. I look forward to contributing to the Companys ongoing achievements in my capacity as a consultant and am confident of ObsEvas future success.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve womens 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 ObsEvas 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 U.S. Food and Drug Administration (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, clinical development of ObsEvas product candidates, including the timing, advancement of, and potential therapeutic benefits of such product candidates, including linzagolix, the potential for linzagolix and other product candidates to be commercially competitive, the success of the Companys partnerships with third parties, expectations regarding regulatory and development milestones and ObsEvas ability to obtain and maintain regulatory approvals for its product candidates. 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 New Drug Application process for linzagolix, ObsEvas 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 ObsEvas Annual Report on Form 20-F for the year ended December 31, 2021 filed with 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 ObsEvas 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 Dillon
shauna.dillon@obseva.ch
+41 22 552 1550
Investor Contact
Katja Bührer
katja.buhrer@obseva.com
+1 (917) 969-3438