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 December 2021 positive Committee for Medicinal Products for Human Use (CHMP) opinion.

Linzagolix for endometriosis: Additional data from the 6-month analysis are expected in 1Q:22. Additional data from the post-treatment follow-up of the Phase 3 EDELWEISS 3 trial are expected in 2Q:22 and from the post-treatment follow-up of the extension study in 4Q:22

Linzagolix for Uterine Fibroids:    ObsEva is developing linzagolix, an oral GnRH receptor antagonist with potential best-in-class efficacy, a favorable tolerability profile, and unique and flexible dosing options for the treatment of uterine fibroids. 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. The CHMP of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of linzagolix in December 2021. ObsEva is working with the EMA toward approval, and is in dialogue with the regulatory agency to address questions on the marketing authorization application (MMA), which is expected to be discussed at the April CHMP plenary meeting. On February 10, 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. In the United States, the New Drug Application (NDA) 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.

Linzagolix for Endometriosis:    On January 6, 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 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 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 data from the 6-month analysis are expected in 1Q:22. Additional data from the post-treatment follow-up of the Phase 3 EDELWEISS 3 trial are expected in 2Q:22 and from the post-treatment follow-up of the extension study in 4Q:22

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 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.

Will Brown was appointed as Chief Financial Officer and member of the company’s Executive Committee. Mr. Brown is a Certified Public Accountant with deep experience in capital markets, accounting, and finance.

Katja Bührer was appointed as Chief Strategy Officer and member of the company’s Executive Committee. Ms. Bührer’s background spans expertise in corporate strategy, investor relations advisory, financial journalism, and capital markets.

ObsEva had cash and cash equivalents of $54.7 million at December 31, 2021 compared to $31.2 million at December 31, 2020. The increase of $23.5 million is primarily attributable to $51.7 million of net cash received during 2021 from the utilization of its at-the-market offering program, $22.1 million in warrant exercise proceeds, a $25 million upfront payment for the ebopiprant licensing agreement with Organon, offset by $70.3 million of cash used for operating activities.

Subsequent to December 31, 2021, the Company received $8.3 million from its securities purchase agreement with certain funds and accounts managed by JGB Management, Inc. (JGB), a $5.7 million upfront payment for the licensing agreement with Theramex, $4.6 million from its at-the-market offering program, and $2.9 million in other receivable collections.

In October 2021, ObsEva entered into a securities purchase agreement with JGB, which is structured to provide up to $135 million in borrowing capacity, available in nine tranches, subject to certain conditions to funding. The Company received $30 million at closing, which was used to retire the Company’s existing debt facility with Oxford Finance LLC, and $8.3 million in January 2021 in the second tranche under the agreement. In connection with the second tranche, the Company amended the securities purchase agreement and made a cash payment of $1.25 million in exchange for a waiver by JGB of certain funding conditions for the second tranche.

Operating income other than revenue was $20.1 million for the year ended December 31, 2021 compared to $17,000 in the prior year. The increase year-over-year was due to the recognition of the upfront payment associated with the ebopiprant licensing agreement, net of fees and recognition of the associated intangible asset.

Research and development expenses were $53.1 million for the year ended December 31, 2021, compared to $67.5 million in the prior year period, representing a decrease of $14.4 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 $21.5 million for the year ended December 31, 2021 compared to $12.2 million in the prior year, an increase of $9.3 million. The increase was attributable to professional fees associated with commercial launch preparation, legal fees, insurance, and additional employee compensation costs.

Finance expense was $4.3 million for the year ended December 31, 2021, compared to $3.9 million for the prior year. The increase was primarily due to higher interest costs related to our borrowings under the convertible note financing agreement with JGB Management, Inc. Finance income remained consistent year over year with $0.6 million for the year ended December 31, 2021, as compared to $0.65 million for the prior year period.

Net loss for the year ended December 31, 2021 was $58.4 million, or $0.78 net loss per share, compared to $83.0 million in the prior year, or $1.67 net loss per share. The difference in net loss was primarily attributable to the recognition of the upfront payment for the ebopiprant licensing agreement, lower research and development expenses, partially offset by higher general and administrative expenses.

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