-Linzagolix for uterine fibroids: Pending regulatory approval in the US and
-Linzagolix for endometriosis: Readout from Phase 3 EDELWEISS 3 study expected in Q4:21-
-Ebopiprant: Global License Agreement completed with Organon -
-Actively pursuing new indications and partnerships to maximize value of pipeline candidates-
Ad hoc announcement pursuant to Art. 53 LR of the
“Recent months have been noteworthy for many reasons, especially the progress made in defining the futures of both the linzagolix and ebopiprant programs,” reported Brian O’Callaghan, CEO of ObsEva. “Regulatory filings for approval of linzagolix in the treatment of uterine fibroids have now been made in both
Anticipated Milestones
- Linzagolix for uterine fibroids: Committee for Medicinal Products for Human Use (CHMP) marketing approval recommendation (Q4:21)
- Linzagolix for endometriosis: Phase 3 EDELWEISS 3 study topline results readout (Q4:21)
Pipeline Update
- Linzagolix for Uterine Fibroids:
ObsEva is developing linzagolix, an oral GnRH receptor antagonist with the prospect to treat more women due to its 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 only GnRH antagonist in uterine fibroids with a low dose non-ABT option to address the needs of women who cannot or do not want to take hormones. The Company is working closely with theEuropean Medicines Agency (EMA) to achieve marketing approval, with an approval recommendation (positive opinion) from the CHMP projected in Q4:2021. In Q3:2021, the Company also submitted a New Drug Application with theUS FDA . Commercial planning efforts are also underway with a recently established relationship with Syneos Health (NASDAQ: SYNH).
- 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
- Ebopiprant for Treatment of Preterm Labor: In Q3:2021,
ObsEva granted a license to Organon (NYSE: OGN) for the global development, manufacturing and commercial rights to ebopiprant. Plans for the further development of ebopiprant are yet to be announced.
- 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.
Financial Update
Net income for the quarter ended
As of
In
The third quarter 2021 financial report will be available in the financial reports section of the Company’s website.
To access the financial reports section of the Company’s website, please click [here].
To access the third quarter 2021 financial report directly, please click [here].
About
Cautionary Note Regarding Forward Looking Statements of
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 of and commercialization plans for ObsEva’s product candidates, 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, 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
For further information, please contact:
CEO Office Contact:
Shauna.dillon@obseva.ch
+41 22 552 1550
Investor Contact:
jallaire@lifesciadvisors.com
+1 (617) 435-6602
Consolidated Statements of Comprehensive Loss
Three-Month Period Ended | Nine-Month Period Ended | |||||||||||||||
(In USD ’000, except share and per share data) - unaudited | 2021 | 2020 | 2021 | 2020 | ||||||||||||
Operating income other than revenue | 20,098 | 3 | 20,108 | 11 | ||||||||||||
OPERATING EXPENSES | ||||||||||||||||
Research and development expenses | (11,531 | ) | (20,125 | ) | (41,532 | ) | (52,690 | ) | ||||||||
General and administrative expenses | (7,035 | ) | (3,514 | ) | (15,114 | ) | (9,414 | ) | ||||||||
Total operating expenses | (18,566 | ) | (23,639 | ) | (56,646 | ) | (62,104 | ) | ||||||||
OPERATING INCOME / (LOSS) | 1,532 | (23,636 | ) | (36,538 | ) | (62,093 | ) | |||||||||
Finance income | 128 | 184 | 702 | 292 | ||||||||||||
Finance expense | (822 | ) | (918 | ) | (2,423 | ) | (2,619 | ) | ||||||||
NET INCOME / (LOSS) BEFORE TAX | 838 | (24,370 | ) | (38,259 | ) | (64,420 | ) | |||||||||
Income tax (expense) / benefit | (19 | ) | (14 | ) | (70 | ) | 5 | |||||||||
NET INCOME / (LOSS) FOR THE PERIOD | 819 | (24,384 | ) | (38,329 | ) | (64,415 | ) | |||||||||
Net earnings / (loss) per share | ||||||||||||||||
Basic | 0.01 | (0.49 | ) | (0.53 | ) | (1.35 | ) | |||||||||
Diluted | 0.01 | (0.49 | ) | (0.53 | ) | (1.35 | ) | |||||||||
Weighted Average Number of Shares Outstanding | 77,971,008 | 50,086,923 | 74,152,705 | 47,848,862 |
Consolidated Balance Sheets
(In USD ’000) - unaudited | 2021 | 2020 | ||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | 62,884 | 31,183 | ||||||
Other receivables | 3,428 | 397 | ||||||
Prepaid expenses | 5,746 | 5,388 | ||||||
Total current assets | 72,058 | 36,968 | ||||||
Non-current assets | ||||||||
Right-of-use assets | 730 | 1,425 | ||||||
Furniture, fixtures and equipment | 62 | 151 | ||||||
Intangible assets | 24,503 | 26,608 | ||||||
Other long-term assets | 283 | 295 | ||||||
Total non-current assets | 25,578 | 28,479 | ||||||
Total assets | 97,636 | 65,447 | ||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
Current liabilities | ||||||||
Other payables and current liabilities | 7,347 | 10,760 | ||||||
Accrued expenses | 10,723 | 10,248 | ||||||
Current lease liabilities | 698 | 696 | ||||||
Total current liabilities | 18,768 | 21,704 | ||||||
Non-current liabilities | ||||||||
Non-current lease liabilities | 383 | 952 | ||||||
Non-current borrowings | 25,623 | 25,300 | ||||||
Post-employment obligations | 8,116 | 8,218 | ||||||
Other long-term liabilities | 577 | 919 | ||||||
Total non-current liabilities | 34,699 | 35,389 | ||||||
Shareholders’ equity | ||||||||
Share capital | 6,948 | 4,878 | ||||||
(630) | (304 | ) | ||||||
Share premium | 424,561 | 356,822 | ||||||
Reserves | 31,014 | 26,353 | ||||||
Accumulated losses | (417,724) | (379,395 | ) | |||||
Total shareholders’ equity | 44,169 | 8,354 | ||||||
Total liabilities and shareholders’ equity | 97,636 | 65,447 |
###
Attachment
- Press Release in Pdf
Source:
2021 GlobeNewswire, Inc., source