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 November 2019
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. 333-233069, 333-222820 and 333-221462) of ObsEva SA (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
Exhibit |
Description | |
99.1 | Press Release dated November 6, 2019. | |
99.2 | Press Release dated November 7, 2019. | |
99.3 | Press Release dated November 7, 2019. |
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: November 7, 2019 | By: | /s/ Ernest Loumaye | ||||
Name Ernest Loumaye | ||||||
Title: Chief Executive Officer |
Exhibit 99.1
ObsEva SA to Hold Conference Call to Discuss IMPLANT 4 Trial Results and Third Quarter 2019 Financial and Business Update on November 7, 2019
Geneva, Switzerland and Boston, MA November 6, 2019 - ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today announced that it will release results from the Phase 3 IMPLANT 4 clinical trial of nolasiban and third quarter 2019 financial results on Thursday, November 7, 2019. ObsEva management will host an investment community conference call at 8 a.m. Eastern Time, 2 p.m. Central European Time, Thursday November 7, 2019, to discuss these results.
Investors may participate by dialing (844) 419-1772 for U.S. callers or +1 (213) 660-0921 for international callers, and referring to conference ID 9273485. A webcast of the conference call can be accessed under the Investors section of ObsEvas website www.obseva.com.
About ObsEva
ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a womans 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 treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol OBSV and on the SIX Swiss Exchange where it is trading under the ticker symbol OBSN. For more information, please visit www.ObsEva.com.
For further information, please contact:
Media Contact Switzerland and Europe:
Christophe Lamps
Dynamics Group
cla@dynamicsgroup.ch
+41 22 308 6220 Office
+41 79 476 26 87 Mobile
Media Contact U.S.:
Marion Janic
RooneyPartners LLC
mjanic@rooneyco.com
+1 212 223 4017 Office
+1 646 537 5649 Mobile
CEO Office Contact:
Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550
Investor Contact:
Mario Corso
Senior Director, Investor Relations
mario.corso@obseva.com
+1 857 972 9347 Office
+1 781 366 5726 Mobile
Exhibit 99.2
Obseva Announces That Nolasiban Implant 4 Study Did Not Meet Primary
Endpoint
Company to Discontinue Current Nolasiban IVF Program
Geneva, Switzerland and Boston, MA November 7, 2019 ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today announced that the Phase 3 clinical trial results from its European confirmatory study of nolasiban (IMPLANT 4) in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF) did not meet the primary endpoint of an increase in ongoing pregnancy rate at 10 weeks, (39.1 % placebo vs 40.5 % nolasiban) (p = 0.745). Nolasiban was well tolerated. All subjects will continue to be followed up to delivery and infant development will be assessed up to 6 months.
IMPLANT4 is a randomized, double blind, placebo controlled clinical trial that included 807 patients from more than 40 fertility clinics across nine European countries. Women undergoing a Day 5 transfer of a single, fresh embryo were randomized to receive either a single 900 mg dose of nolasiban or placebo (1:1) 4 hours prior to ET. The primary endpoint of the trial was ongoing pregnancy as determined by ultrasound at 10 weeks following ET.
We are extremely disappointed with these unexpected results, not in the least for the millions of women hoping to have a baby through IVF. I would like to acknowledge the excellent execution of the study by our employees, and to thank our investigators as well as the women who participated in our trials, said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva. Based on these results, we have decided to discontinue the current nolasiban IVF program and will explore potential repositioning of the product candidate. We remain more committed than ever to developing our innovative pipeline of late-stage products aimed at unmet needs in uterine fibroids, endometriosis and preterm labor and will focus our resources on these programs immediately.
Conference Call
ObsEva will host a conference call and audio webcast today beginning at 8:00 a.m. Eastern Time/2:00 p.m. Central European Time to discuss IMPLANT 4 trial results and third quarter financial results. Investors may participate by dialing (844) 419-1772 for U.S. callers or +1 (213) 660-0921 for international callers and referring to conference ID 9273485. A live or archived webcast of the conference call can be accessed under the Investors section of ObsEvas website www.obseva.com.
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About Nolasiban
Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist which was licensed from Merck KGaA, Darmstadt, Germany, in 2013. ObsEva retains worldwide, exclusive, commercial rights.
About linzagolix
Linzagolix (previously known as OBE2109) is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for linzagolix.
About OBE022
ObsEva is developing OBE022, a potential first-in-class, once daily, oral and selective prostaglandin F2alpha receptor antagonist for the treatment of preterm labor. OBE022 was licensed from Merck KGaA, Darmstadt, Germany, in 2015. ObsEva retains worldwide, exclusive, commercial rights.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol OBSV and on the SIX Swiss Exchange where it is trading 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 believe, expect, may, plan, potential, will, and similar expressions, and are based on ObsEvas current beliefs and expectations. These forward-looking statements include statements regarding the potential to reposition nolasiban. 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 and related regulatory reviews and approvals, including the risk that the results of earlier clinical trials may not be predictive of the results of later-stage clinical trials, ObsEvas reliance on third parties over which it may not always have full control, 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, 2018, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEvas website at
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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.
For further information, please contact:
Media Contact Switzerland and Europe:
Christophe Lamps
Dynamics Group
cla@dynamicsgroup.ch
+41 22 308 6220 Office
+41 79 476 26 87 Mobile
Media Contact U.S.:
Marion Janic
RooneyPartners LLC
mjanic@rooneyco.com
+1 212 223 4047 Office
+1 646 537 5649 Mobile
CEO Office Contact:
Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550
Investor Contact:
Mario Corso
Senior Director, Investor Relations
mario.corso@obseva.com
+1 857 972 9347 Office
+1 781 366 5726 Mobile
###
3
Exhibit 99.3
ObsEva Announces Third Quarter 2019 Financial Results
Reports Update on Three Womens Health Product Candidates
Focusing on Phase 3 Programs for Linzagolix and the Phase 2
Program for OBE022
Company to Host Conference Call/Webcast Today at 8 am ET/2pm CET
GENEVA, Switzerland and BOSTON, MA (November 7, 2019) ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today reported financial results for the third quarter ended September 30, 2019 and announced top line results of the IMPLANT 4 trial.
Despite the unexpected results for IMPLANT 4, we remain optimistic and committed to the development of our innovative pipeline with potentially best in class product candidates for serving unmet medical needs of millions of women. In particular, we are looking forward to PRIMROSE 2 study top line results, which we expect to announce this quarter said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva.
Pipeline Update
1. | Nolasiban |
IMPLANT 4 study did not meet primary endpoint: The Company has decided to discontinue the current development of nolasiban for IVF and will be exploring potential repositioning of the product.
2. | Linzagolix |
| Completed Patient Randomization for Two Pivotal Phase 3 trials For Women with Uterine Fibroids (PRIMROSE 1 and PRIMROSE 2): The studies include approximately 1,000 women in total with heavy menstrual bleeding (HMB) associated with uterine fibroids. The efficacy and safety of two oral doses of linzagolix are being studied, including 100mg once daily without hormonal add-back therapy (ABT) and 200mg once daily with ABT. |
1
| Positive Phase 2b (EDELWEISS 1) Results Presented at the American Society of Reproductive Medicine (ASRM) Annual Meeting: ObsEva presented positive 52-week results of linzagolix for treating endometriosis-associated pain. |
| Phase 3 trials EDELWEISS 2 (U.S.) and EDELWEISS 3 (U.S. and Europe) Currently Enrolling Patients: Each trial will enroll approximately 450 women with endometriosis-associated pain, and will include two oral doses of linzagolix, 75mg once daily without low-dose ABT and 200mg once daily with ABT. |
3. | OBE022 To Delay Preterm Birth |
| Data Monitoring Committee Recommended Continuation of Phase 2 Study in Europe (PROLONG): In July 2019, the independent data monitoring committee (IDMC) recommended continuing the ongoing PROLONG trial with no modifications based upon the first 30 patients enrolled in Part B. Part B is the multicenter, randomized, double-blind, placebo-controlled portion of the trial that will enroll up to 120 patients with preterm labor at a gestational age of between 24 and 34 weeks. |
Anticipated Near-Term Milestones
ObsEva expects to achieve the following clinical and regulatory milestones in 2019 2020:
Fourth quarter 2019
| Linzagolix: Report six-month primary endpoint data from the PRIMROSE 2 Phase 3 trial (U.S. and Europe) to treat HMB due to uterine fibroids. |
| OBE022: Receive interim update in 60 patients dosed in Part B of the PROLONG Phase 2a trial in acute pre-term labor and decide next steps in development. |
Second Quarter 2020
| Linzagolix: Report six-month primary endpoint data from the Phase 3 PRIMROSE 1 trial (U.S.) of linzagolix for the treatment of HMB due to uterine fibroids. |
Second Half 2020
| Linzagolix: |
| Read-out 12 month data for PRIMROSE 1 and PRIMROSE 2 |
| Conduct pre-submission meeting with the European Medicines Agency and the U.S. Food and Drug Administration for uterine fibroid indication. |
| OBEO22: Report PROLONG study final results |
2
Third Quarter 2019 Financial Results
Net loss for the third quarter of 2019 was $27.6 million, or $0.63 per share, compared with a net loss of $18.6 million, or $0.42 per share, for the third quarter of 2018. Research and development expenses were $21.9 million and general and administrative expenses were $4.9 million for the third quarter of 2019, compared with $15.9 million and $3.1 million, respectively, for the third quarter of 2018. The net loss for the third quarter of 2019 included non-cash expenses of $3.0 million for stock-based compensation, compared with $2.0 million in the prior-year period.
As of September 30, 2019, the Company had cash and cash equivalents of $91.0 million, compared with $138.6 million as of December 31, 2018.
The full Q3 2019 financial report shall be available from November 11, 2019, in the financial reports section of the Companys website.
To access the financial reports section of the Companys website, please click [here].
To access the Q3 2019 financial report directly, please click [here].
Conference Call Today
ObsEva will host a conference call and audio webcast today beginning at 8:00 a.m. Eastern Time/2:00 p.m. Central European Time to provide a business update and discuss the third quarter results. Investors may participate by dialing (844) 419-1772 for U.S. callers or +1 (213) 660-0921 for international callers and referring to conference ID 9273485. A live or archived webcast of the conference call can be accessed under the Investors section of ObsEvas website www.ObsEva.com.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve womens 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 treating endometriosis, uterine fibroids, preterm labor, and improving ET outcomes following IVF. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol OBSV and on the SIX Swiss Exchange where it is trading 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 believe, expect, may, plan, potential, will, and similar expressions, and are based on ObsEvas current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEvas product candidates, the timing of enrollment in and data from clinical trials and the results of interactions with
3
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, ObsEvas reliance on third parties over which it may not always have full control, 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, 2018, the Risk Factors filed as Exhibit 99.1 to ObsEvas Form 6-K filed on August 7, 2019, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEvas 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.
For further information, please contact:
Media Contact Switzerland and Europe:
Christophe Lamps
Dynamics Group
cla@dynamicsgroup.ch
+41 22 308 6220 Office
+41 79 476 26 87 Mobile
Media Contact U.S.:
Marion Janic
RooneyPartners LLC
mjanic@rooneyco.com
+1 212 223 4017 Office
+1 646 537 5649 Mobile
CEO Office Contact:
Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550
Investor Contact:
Mario Corso
Senior Director, Investor Relations
mario.corso@obseva.com
+1 857 972 9347 Office
+1 781 366 5726 Mobile
4
Consolidated Statements of Comprehensive Loss
Three-month period ended September 30, |
Nine-Month Period Ended September 30, |
|||||||||||||||
(in USD 000, except share and per share data)unaudited | 2019 | 2018 | 2019 | 2018 | ||||||||||||
Operating income other than revenue |
5 | 2 | 11 | 10 | ||||||||||||
OPERATING EXPENSES |
||||||||||||||||
Research and development expenses |
(21,935 | ) | (15,909 | ) | (70,513 | ) | (46,945 | ) | ||||||||
General and administrative expenses |
(4,865 | ) | (3,137 | ) | (16,306 | ) | (10,287 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
(26,800 | ) | (19,045 | ) | (86,819 | ) | (57,231 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
OPERATING LOSS |
(26,795 | ) | (19,043 | ) | (86,808 | ) | (57,221 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Finance income |
219 | 430 | 425 | 616 | ||||||||||||
Finance expense |
(1,021 | ) | | (1,608 | ) | | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
NET LOSS BEFORE TAX |
(27,597 | ) | (18,613 | ) | (87,991 | ) | (56,605 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Income tax (expense) |
(10 | ) | 23 | (51 | ) | 23 | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
NET LOSS FOR THE PERIOD |
(27,607 | ) | (18,590 | ) | (88,042 | ) | (56,582 | ) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per share |
||||||||||||||||
Basic |
(0.63 | ) | (0.42 | ) | (2.01 | ) | (1.45 | ) | ||||||||
Diluted |
(0.63 | ) | (0.42 | ) | (2.01 | ) | (1.45 | ) | ||||||||
Weighted Average Number of Shares Outstanding |
43,739,938 | 43,196,686 | 43,693,245 | 39,092,256 |
5
Consolidated Balance Sheets
(in USD 000)unaudited | September 30, 2019 |
December 31, 2018 |
||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
91,017 | 138,640 | ||||||
Other receivables |
776 | 885 | ||||||
Prepaid expenses |
5,964 | 5,715 | ||||||
|
|
|
|
|||||
Total current assets |
97,757 | 145,240 | ||||||
Non-current assets |
||||||||
Right-of-use assets |
2,202 | | ||||||
Furniture, fixtures and equipment |
261 | 319 | ||||||
Intangible assets |
26,608 | 21,608 | ||||||
Other long-term assets |
270 | 273 | ||||||
|
|
|
|
|||||
Total non-current assets |
29,341 | 22,200 | ||||||
|
|
|
|
|||||
Total assets |
127,098 | 167,440 | ||||||
|
|
|
|
|||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current liabilities |
||||||||
Current tax liability |
46 | | ||||||
Other payables and current liabilities |
6,515 | 2,766 | ||||||
Accrued expenses |
19,595 | 14,163 | ||||||
Current lease liabilities |
598 | | ||||||
|
|
|
|
|||||
Total current liabilities |
26,754 | 16,929 | ||||||
Non-current liabilities |
||||||||
Non-current lease liabilities |
1,665 | | ||||||
Non-current borrowings |
24,830 | | ||||||
Post-employment obligations |
3,608 | 3,547 | ||||||
Other long-term liabilities |
414 | 48 | ||||||
|
|
|
|
|||||
Total non-current liabilities |
30,517 | 3,595 | ||||||
Shareholders equity |
||||||||
Share capital |
3,448 | 3,420 | ||||||
Share premium |
318,226 | 314,565 | ||||||
Reserves |
20,122 | 12,858 | ||||||
Accumulated losses |
(271,969 | ) | (183,927 | ) | ||||
|
|
|
|
|||||
Total shareholders equity |
69,827 | 146,916 | ||||||
|
|
|
|
|||||
Total liabilities and shareholders equity |
127,098 | 167,440 | ||||||
|
|
|
|
###
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