obsv-ex993

-Linzagolix (Yselty®) for uterine fibroids: US New Drug Application filing planned in Q3:21; European marketing approval recommendation anticipated in Q4:21-

-Actively pursuing new indications and partnerships to maximize value of pipeline candidates-

GENEVA, Switzerland – August 5, 2021 – 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 quarter ended June 30, 2021 and provided a business update.

“The outset of 2021 was focused on strengthening the financial position of the company, and we have continued to execute on our strategic plan, which most recently includes the global license to Organon of development, manufacturing and commercial rights to ebopiprant,” said Brian O’Callaghan, CEO of ObsEva. “This partnership is an important validation of ObsEva’s ability to generate value, and we view Organon as the ideal partner for the development and commercialization of ebopiprant to address the significant unmet need in preterm labor. In parallel, we remain laser focused on advancing linzagolix through the regulatory approval process and preparing for its commercialization. We look forward to providing additional updates in the near future.”

ObsEva expects to achieve the following key clinical and regulatory objectives in 2021:

Linzagolix for Endometriosis: The EDELWEISS 3 study in the EU is progressing as planned, with randomization of patients completed and primary endpoint data expected in Q4:2021. The ongoing Phase 3 EDELWEISS 3 study (Europe and US) enrolled 486 patients with endometriosis-associated pain, with a co-primary endpoint of response on both dysmenorrhea (menstrual pain) and non-menstrual pelvic pain. The study includes a 75 mg once-daily dose without hormonal ABT, and a 200 mg once-daily dose in combination with hormonal ABT (1 mg E2 / 0.5mg NETA). Subjects who complete the initial six-month treatment period have the option to enter a six-month treatment extension.

Net loss for the quarter ended June 30, 2021 was $19.1 million, or $0.25 per share, compared with a net loss of $18.2 million, or $0.38 per share, for the quarter ended June 30, 2020. Research and development expenses were $14.5 million and general and administrative expenses were $3.9 million for the quarter ended June 30, 2021, compared with $15.4 million and $2.2 million, respectively, for the corresponding prior year quarter. Net loss for the quarter ended June 30, 2021 included non-cash expenses of $0.9 million for stock-based compensation, compared with $1.4 million for stock-based compensation in the corresponding prior year quarter.

As of June 30, 2021, ObsEva had cash and cash equivalents of $58.9 million, compared with $31.2 million as of December 31, 2020.

The second quarter 2021 financial report will be available in the financial reports section of the Company’s website.

ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. 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.

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 other similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of and commercialization plans for ObsEva’s product candidates, ObsEva’s ability to generate value, expectations regarding regulatory and development milestones, including the potential timing of regulatory submissions to the EMA and FDA and ObsEva’s ability to obtain and maintain regulatory approvals for its product candidates, and the results of interactions with regulatory authorities. 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, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the 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 other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://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.

	Three-Month Period Ended June 30,						Six-Month Period Ended June 30,
(in USD ’000, except share and per share data) - unaudited	2021			2020			2021			2020
Operating income other than revenue		4			4			10			8
OPERATING EXPENSES
Research and development expenses		(14,485	)		(15,377	)		(30,001	)		(32,565	)
General and administrative expenses		(3,888	)		(2,191	)		(8,079	)		(5,900	)
Total operating expenses		(18,373	)		(17,568	)		(38,080	)		(38,465	)
OPERATING LOSS		(18,369	)		(17,564	)		(38,070	)		(38,457	)
Finance income		(55	)		48			574			108
Finance expense		(690	)		(690	)		(1,601	)		(1,701	)
NET LOSS BEFORE TAX		(19,114	)		(18,206	)		(39,097	)		(40,050	)
Income tax (expense) / benefit		(30	)		38			(51	)		19
NET LOSS FOR THE PERIOD		(19,144	)		(18,168	)		(39,148	)		(40,031	)
Net loss per share
Basic		(0.25	)		(0.38	)		(0.54	)		(0.86	)
Diluted		(0.25	)		(0.38	)		(0.54	)		(0.86	)
Weighted Average Number of Shares Outstanding		75,809,484			47,709,508			72,211,911			46,717,535

(in USD ’000) - unaudited	June 30, 2021			December 31, 2020
ASSETS
Current assets
Cash and cash equivalents		58,923			31,183
Other receivables		458			397
Prepaid expenses		8,010			5,388
Total current assets		67,391			36,968
Non-current assets
Right-of-use assets		834			1,425
Furniture, fixtures and equipment		65			151
Intangible assets		26,608			26,608
Other long-term assets		284			295
Total non-current assets		27,791			28,479
Total assets		95,182			65,447
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities
Other payables and current liabilities		7,515			10,760
Accrued expenses		10,312			10,248
Current lease liabilities		694			696
Total current liabilities		18,521			21,704
Non-current liabilities
Non-current lease liabilities		567			952
Non-current borrowings		25,519			25,300
Post-employment obligations		8,074			8,218
Other long-term liabilities		877			919
Total non-current liabilities		35,037			35,389
Shareholders’ equity
Share capital		6,948			4,878
Treasury shares		(630	)		(304	)
Share premium		424,567			356,822
Reserves		29,282			26,353
Accumulated losses		(418,543	)		(379,395	)
Total shareholders’ equity		41,624			8,354
Total liabilities and shareholders’ equity		95,182			65,447