0001193125-19-286732.txt : 20191107 0001193125-19-286732.hdr.sgml : 20191107 20191107091155 ACCESSION NUMBER: 0001193125-19-286732 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20191107 FILED AS OF DATE: 20191107 DATE AS OF CHANGE: 20191107 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ObsEva SA CENTRAL INDEX KEY: 0001685316 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: V8 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37993 FILM NUMBER: 191198359 BUSINESS ADDRESS: STREET 1: CHEMIN DES AULX, 12 CITY: PLAN-LES-OUATES STATE: V8 ZIP: 1228 BUSINESS PHONE: 0041-0-22-552-1558 MAIL ADDRESS: STREET 1: CHEMIN DES AULX, 12 CITY: PLAN-LES-OUATES STATE: V8 ZIP: 1228 6-K 1 d829317d6k.htm 6-K 6-K

 

 

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 registrant’s 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such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.



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
EX-99.1 2 d829317dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

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 women’s 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 ObsEva’s 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 woman’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 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

EX-99.2 3 d829317dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

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 women’s 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 ObsEva’s website www.obseva.com.

 

1


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 women’s 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 ObsEva’s 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, ObsEva’s 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 ObsEva’s 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 ObsEva’s website at

 

2


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

EX-99.3 4 d829317dex993.htm EX-99.3 EX-99.3

Exhibit 99.3

 

LOGO

ObsEva Announces Third Quarter 2019 Financial Results

– Reports Update on Three Women’s 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 women’s 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 Company’s website.

To access the financial reports section of the Company’s 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 ObsEva’s website www.ObsEva.com.

About ObsEva

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 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 ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s 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, ObsEva’s 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 ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2018, the Risk Factors filed as Exhibit 99.1 to ObsEva’s 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 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.

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  
  

 

 

   

 

 

 

###

 

6

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