Innovating Women's Reproductive Health and Pregnancy Therapeutics - September 2019
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September 2019
Innovating Women’s Reproductive Health
and Pregnancy Therapeutics
DISCLAIMER
Matters discussed in this presentation may constitute forward-looking statements. The forward-looking statements contained in this
presentation reflect our views as of the date of this presentation about future events and are subject to risks, uncertainties,
assumptions, and changes in circumstances that may cause our actual results, performance, or achievements to differ significantly
from those expressed or implied in any forward-looking statement. Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee future events, results, performance, or achievements. Some of
the key factors that could cause actual results to differ from our expectations include our plans to develop and potentially
commercialize our product candidates; our planned clinical trials and preclinical studies for our product candidates; the timing of
and our ability to obtain and maintain regulatory approvals for our product candidates; the extent of clinical trials potentially required
for our product candidates; the clinical utility and market acceptance of our product candidates; our commercialization, marketing
and manufacturing capabilities and strategy; our intellectual property position; and our ability to identify and in-license additional
product candidates. For further information regarding these risks, uncertainties and other factors that could cause our actual results
to differ from our expectations, you should read our Annual Report on Form 20-F for the year ended December 31, 2018, as filed
with the Securities and Exchange Commission on March 5, 2019 and our other filings we make with the Securities and Exchange
Commission from time to time. We expressly disclaim any obligation to update or revise the information herein, including the
forward-looking statements, except as required by law. Please also note that this presentation does not constitute an offer to sell or
a solicitation of an offer to buy any securities.
This presentation concerns products that are under clinical investigation and which have not yet been approved for marketing by the
U.S. Food and Drug Administration. It is currently limited by federal law to investigational use, and no representation is made as to
its safety or effectiveness for the purposes for which it is being investigated. The trademarks included herein are the property of the
owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products.
This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size
and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned
not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the
future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 2
O B S E VA I S A C L I N I C A L S TA G E B I O P H A R M A
C O M PA N Y D E D I C AT E D TO W O M E N ’ S H E A LT H
Strategic Focus
We are passionately focused to innovate for (Women ages 15 - 49)
addressing serious, quality-of-life impacting
conditions and reproductive challenges Infertility – ART
faced by women around the world.
Our lead candidate Nolasiban has the Uterine Fibroids
potential to be the first-in-class to increase
rate of live birth following Embryo Transfer
(IVF)
Endometriosis
Our second product candidate Linzagolix
has the potential to be best-in-class in
treating endometriosis and uterine fibroids Preterm Labor
Other Women’s
Tickers: OBSV (NASDAQ) - OBSN (SIX) Health Needs
Headquarters: Geneva, Switzerland U.S. office: Boston, MA
Employees: 53
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O B S E VA – A U N I Q U E I N V E S T M E N T O P P O R T U N I T Y
• Multibillion USD opportunity
Deliver more IVF babies 3 Product candidates in 4 large indications
NOLASIBAN
at lower cost Wholly-owned exclusive WW rights*
IP ≥ mid-2030 for all 3 product candidates
Effective without • Major catalysts in 2019
LINZAGOLIX hormone
replacement therapy Nolasiban IMPLANT 4 IVF Ph3 readout and MAA filing
Linzagolix PRIMROSE Fibroid Ph3 readout
OBE022 PROLONG PTL Ph2a readout
OBE022 Potential to save
newborn lives • NOLASIBAN – Expected first launch in EU (1Q 2021)
* Except for linzagolix Asia rights own by KISSEI
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SEASONED LEADERSHIP TEAM
Ernest Loumaye, Tim Adams Jean-Pierre Gotteland, PhD Wim Souverijns Beth Garner
MD, PhD, OB/GYN Chief Financial Officer Chief Scientific Officer Chief Commercial Officer Chief Medical Officer
CEO and Co-founder
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O B S E VA P I P E L I N E
PRODUCT PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NEXT MILESTONES COMMERCIAL
CANDIDATE RIGHTS
IVF – Ph3 IMPLANT 2 EU * Primary endpoint data
IMPLANT 4 Q4 2019
NOLASIBAN IVF – Ph3 IMPLANT 4 EU ** Exclusive
Oral oxytocin EU MAA filing planned
Worldwide
receptor antagonist
IVF – Ph3 IMPLANT 3 US ** late 2019
U.S. IMPLANT 3 Initiation
Q4 2019/Q1 2020
IVF – Ph3 IMPLANT 5 CHINA
Endometriosis – Ph2b EDELWEISS *** LT follow-up completed
1H:19
Endometriosis – Ph3 EDELWEISS 2 US ***
LINZAGOLIX Initiated Phase 3
Q2 2019 Exclusive
(OBE2109) Endometriosis – Ph3 EDELWEISS 3 EU & US Worldwide
Oral GnRH (ex-Asia)
receptor antagonist Uterine Fibroids – Ph3 PRIMROSE 1 US 24W Primary Endpoint
Data Q4 2019-H1 2020
Uterine Fibroids – Ph3 PRIMROSE 2 EU & US NDA targeted end of 2020
OBE022 EU Phase 2a PROLONG Exclusive
Oral PGF2α Preterm Labor – Ph2a PROLONG Interim Efficacy Q4 2019 Worldwide
receptor antagonist
* Week 10 ongoing pregnancy primary endpoint met – Live Birth Rate secondary endpoint met
** Second Phase 3 study (EU/Canada/Russia) initiated *** Primary and secondary endpoints met
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NOLASIBAN (OBE001) IVF: Deliver more IVF babies at lower cost
N O L A S I B A N ( O B E 0 0 1 ) – F I R S T- I N - C L A S S
O R A L O X Y T O C I N R E C E P T O R A N TA G O N I S T T O I M P R O V E
E M B RY O T R A N S F E R O U T C O M E ( I V F )
NOLASIBAN
Well-characterized profile; Positive Phase 3 EU trial results
At a Glance Dosing Profile Target Markets
• Oxytocin Receptor • Single oral 900mg dose +/- 4 • >2.0M ART/IVF cycles/year
Antagonist hours prior to embryo globally
transfer
• MOA uterine contractions/ • >800K cycles in Europe and
blood flow, endometrium • tmax at 2-4h; t1/2= 12h China
receptivity
• High bioavailability • ~260K cycles in US in 2016
• Exclusive worldwide license
from Merck Serono • >650 subjects exposed – well • ART cycle cost: $10-20K+ in
tolerated the US, € 4-10K in the
• IP Protection to ≥ 2035 - 2036 EU/China
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I N F E R T I L I T Y I S A G L O B A L P U B L I C H E A LT H I S S U E
1 Infertility – a health & societal issue
9% of women 20-44 affected globally China: ~22.7 million
Ageing population problematic women aged 20–44
Europe: ~7.2 million
2 Too few healthy babies women aged 20–44
Despite good quality embryos & using
best practice transfer techniques,
Japan: ~1.6 million
IVF success rate not optimal U.S.: ~4.8 million
women aged 20–44 women aged 20–44
3 IVF comes with a significant cost
Patients often self-fund
Payers see an unacceptably high multiple
pregnancy rate
Society pays a higher cost per healthy baby
1WHO infertility website, April 2018. – http://www.who.int/reproductivehealth/topics/infertility/perspective/en/
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 9M U LT I P L E E M B RY O T R A N S F E R S S I G N I F I C A N T LY
I N C R E A S E M U LT I P L E B I R T H S
Four or more
0.7%
Live Multiple
No. ET
birth % birth %
Single ET 50.2% 2.0%
Multiple ET 58.0% 43.8% One
45.8%
• >50% of day 5 transfers with 2 or
more embryos
Three
• Relative 15% higher live birth rate 4.6%
• Relative 2000% higher multiple
birth rate
Two
48.9%
Source: US CDC 2016 ART National Summary Report
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 10NOLASIBAN: PHASE 3 TRIAL IN IVF
IMPLANT 2
Main study Follow Up
2 weeks Primary Analysis
Ongoing
900mg nolasiban
pregnancy
n=194
D3 ET Not pregnant 10 weeks
9 weeks Placebo
n=194
Screening
– IVF
900mg nolasiban
n=194 Neonatal Infant
D5 ET Pregnant W6 W10 FU FU
Placebo
n=196 28 days 6 months
• Age 18–36 y Randomize Birth
• Fresh D3 or D5 SET
• Max 1 failed previous IVF
• P4 ≤ 4.7 nmol on day hCG
• Vaginal P4 for luteal support 778 Patients enrolled – Trial conducted in 41 fertility centers in 9 European countries
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 11E F F I C A C Y R E S U LT S : P R I M A RY A N A LY S I S
POOLED D3/D5
50%
p=0.031 p=0.025
7.1% absolute 40%
Placebo n=390
35.6%
increase or 25% 34.8%
Nolasiban 900mg, n=388
relative increase in 30% 28.5% 27.7%
LBR versus placebo
for pooled D3 and 20%
D5 SET data
10%
0
Ongoing pregnancy Live birth rate (%)
rate at 10 weeks (%)
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IN LBR FOR NOLASIBAN VS. PLACEBO
D3 SET D5 SET
Placebo n=194 Nolasiban n=194 Placebo n=196 Nolasiban n=194
p=0.034 p=0.025
50% 50%
45.9%
44.8%
40% 40%
34.7%
33.2%
p=0.477 p=0.552
30% 30%
25.3% 24.7%
22.7% 22.2%
20% 20%
10% 10%
0 0
Ongoing pregnancy Live birth rate (%) Ongoing pregnancy Live birth rate (%)
rate at 10 weeks (%) rate at 10 weeks (%)
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 13I M P L A N T 2 S A F E T Y F O L L O W- U P R E S U LT S
Pregnancy and Live Birth
• Lower miscarriage rate
• No increase in ectopic pregnancy
• No increase in congenital malformations
28 day Neonatal Follow-up
• No difference in ICU admissions
• No difference in reported neonatal morbidity
6 month Infant follow-up
• No treatment related SAE’s identified
• ASQ-3 scores similar to placebo
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 14IMPLANT 4 EU STUDY DESIGN
READOUT 4Q:19
Main study Follow Up
2 weeks Primary analysis
10 week
900mg Not Pregnant pregnancy rate
9 weeks
n = 410
Screening D5 Set
Placebo Preg. Infant
n = 410 Pregnant W6 W10
FU FU
28 days 6 & 12
months
Randomize
Sample Size Study
Endpoint
Total (per arm) Placebo Active Power
820 (410) Ongoing pregnancy 34.7% 45.9% 90%
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 152019 NOLASIBAN DEVELOPMENT PLAN
IMPLANT4 Trial initiated Q4:18 – MAA filing 4Q:19
800 patients, 40 centers in Europe, Russia, Canada
Day 5, Fresh SET
Primary endpoint 10 week ongoing pregnancy
Planning U.S. Ph3 program start
EOP2 FDA meeting completed Q2:19
Submitting updated IND/protocol, trial start Q4:19/Q1:20
Getting started in China
Opening IND
Assessing development and commercial strategic options
Proprietary & Confidential Materials of ObsEva S.A. 16Key hypotheses on mode of action of OT antagonism in IVF:
supported by literature and nolasiban study conducted in 45 HV undergoing hormonal preparation
mimicking the conditions of frozen thawed embryo transfer1
Reduced uterine
NOLASIBAN contractions2,1
Oxytocin • Uterine contraction frequency reduced over 24 hour
Oxytocin measurement period
Receptor
NOLASIBAN
OTR
Antagonist
Increased endometrium
blood flow3,1
• Improved perfusion (flow and vascularity) in the endometrium,
Functional oxytocin receptors
but not uterus, showing targeted activity favorable for embryo
are expressed in human implantation
non-pregnant uterus on:
• Myometrium smooth muscle cells
• Uterus arteries smooth muscle cells
Increased endometrium
receptivity4,1
• In vitro changes consistent with improved receptivity4 and in vivo
• Endometrium glandular epithelial cells
changes in gene expression potentially relevant for uterine
receptivity1
1 Study 18-OBE001-004: data on file; 45 healthy women underwent hormonal preparation mimicking the conditions of a frozen thawed embryo transfer and treated at 900 or 1800 mg nolasiban or placebo.
Effects on uterine contractions, perfusion, and endometrial genomics in addition to safety and pharmacokinetics were assessed.
2 Lan Reprod Biomed Online. 2012 Sep;25(3):254-60; 3 Kalmantis et al., Arch Gynecol Obstet 2012; 285:265-270; 4 Sztachelska et al., RBMO, 2019
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 17A L E A N O P E R AT I O N TO C O M M E R C I A L I Z E
N O L A S I B A N E F F E C T I V E LY
1 Highly concentrated
2 Sophisticated B2B market
3 No competition
ART Centers (#) 105 134 354 231 82 ~ 500
100 FTEs can drive a blockbuster business
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 18K E Y TA K E AWAY S
Concentrated market allows us to
1 In our reach
go to market ourselves
Nolasiban can impact the physical, mental, and
2 Offsetting the pain of IVF
financial pain of IVF
3 Strong value proposition High economic value of nolasiban
Peak sales potential ranging from $0.5B to nearly
4 Significant opportunity
$2B depending on share & price assumptions
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 19LINZAGOLIX (OBE2109) Endometriosis and Uterine Fibroids: Effective without hormone replacement therapy
L I N Z A G O L I X , A P O T E N T I A L B E S T- I N - C L A S S , O R A L ,
G n R H R E C E P TO R A N TA G O N I S T
LINZAGOLIX
Validated MOA, Ph3 Trials ongoing targeting large populations
At a Glance Dosing Profile Target Markets
• Oral GnRH receptor • 15h t1/2 for once daily dosing • Uterine Fibroids for heavy
antagonist menstrual bleeding
• High bioavailability, low
~ 4 million women diagnosed
• Licensed from Kissei (WW volume of distribution
and treated
rights, excludesAsia)
• No interaction with food, ~ 200,000 surgeries/year
• IP protection to ≥ 2036 CYP3A, OATP1 • Endometriosis for menstrual
and non menstrual pelvic pain
• > 1,850 female subjects
exposed ~ 2.5 million women
diagnosed and treated
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 21O U R A I M – P R O V I D I N G T H E M O S T S I M P L E , C O N V E N I E N T,
E F F E C T I V E A N D S A F E S T, L O N G T E R M T R E AT M E N T
Week 24 Modeled E2 Data
(whiskers represent 10%/90% percentile)
1
Linzagolix 75mg 1 Preferred first line option
2
Linzagolix 200mg + estradiol If needed, higher dose
+ norethindrone acetate* 2
option with ABT available
Linzagolix Daily Dose (mg) for 24 Weeks * Add Back Therapy (ABT) ActivellaTM
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 22P H A S E 2 B E D E LW E I S S C L I N I C A L T R I A L
E N D O M E T R I O S I S PAT I E N T S
Primary endpoint: Secondary
VRS pain score endpoint:
responder rate BMD**
June 2018 September 2018
12 weeks
Placebo 12 weeks Follow-up results
1H 2019
8–14 weeks 50 mg daily 50 mg daily
24 weeks
LEAD-IN 75 mg daily 75 mg daily FOLLOW-UP
100 mg daily 100 mg daily
200 mg daily 200 mg daily Optional
extension
75 mg daily* * Titrated dose 50–100 mg 6 m + 6m f-up
* Titration after 12 weeks based on E2 serum level at weeks 4 and 8
Enrollment 328 patients • 50 sites in US (n=177) • 14 sites in EU (n= 151)
**BMD: Bone Mineral Density
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 23E D E LW E I S S P R I M A RY A N D S E C O N D A RY E N D P O I N T S
* = p valueLINZAGOLIX PHASE 3 ENDOMETRIOSIS TRIALS
E D E LW E I S S 2 A N D 3 + E X T E N S I O N S T U D I E S
Initiated 1H:19
6 months extension study
6 months treatment 75 mg daily
11±5 weeks Placebo 200 mg daily + ABT 6 months
Lead-in 75 mg daily 75 mg daily Follow-up
200 mg daily + ABT 200 mg daily + ABT
6 months Follow-up
Co-Primary endpoint:
DYS/ NMPP responder analysis
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 25PRIMROSE 1 & 2: P H A S E 3 C L I N I C A L T R I A L S F O R T H E T R E AT M E N T O F
U T E R I N E F I B R O I D S : C O N T R O L L I N G H E AV Y M E N S T R U A L B L E E D I N G
Primary endpoint:
Responder-HMB Reduction
8–14 weeks 24 weeks
Q4:19/H1:20 28 weeks
PRIMROSE 1 24 weeks Placebo + placebo add-back
100% US sites
n = 100 Placebo + placebo add-back 200mg + add-back
n = 100 100mg + placebo add-back 100mg + placebo add-back
24w follow-up
n = 100 Screening 100 mg + add-back 100 mg + add-back
n = 100 200 mg + placebo add-back 200 mg + add-back
n = 100 200 mg + add-back 200 mg + add-back
PRIMROSE 2
70% Europe
30% US sites n = 100 Placebo + placebo add-back 200mg + add-back
n = 100 100mg + placebo add-back 100mg + placebo add-back
24w follow-up
n = 100 Screening 100 mg + add-back 100 mg + add-back
n = 100 200 mg + placebo add-back 200 mg + add-back
n = 100 200 mg + add-back 200 mg + add-back
• IND granted in April 2017
• Currently recruiting • Aiming at supporting the registration of two regimens of administration
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 26“ A B T O R N O A B T, T H AT I S T H E Q U E S T I O N ”
D I F F E R E N T I AT I N G B Y N O A B T
*
Gynecologist survey in US shows high preference
1
of no ABT as first line therapy
Preferred dosing is to start low and go higher as
2
needed
Trend toward patients preferring avoidance of
3 hormone therapy vs. endogenous estrogen
management
4 ABT comes with HRT black box warning*
* Activella US FDA Label: cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 27L I N Z A G O L I X S T R AT E G Y A N D D I F F E R E N T I AT I O N :
O B S E VA I S T H E O N LY C O M PA N Y D E V E L O P I N G A S I M P L E & S A F E
N O A B T R E G I M E N F O R B O T H I N D I C AT I O N S
Administration
• Once a day – no food interaction – no DDI
• Applicable to low dose and high dose
Partial E2 suppression – no need for ABT
• Preferred option – only one active drug
• In development for both endometriosis and uterine fibroids
• Responder rate approximating 50% regarded as highly clinically meaningful
Full E2 suppression – need for ABT
• Second line – Combination of 3 active drugs
• In development for both endometriosis and uterine fibroids
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 28OBE022 Preterm Labor: Potential to save newborn lives
O B E 0 2 2 , F I R S T- I N - C L A S S
O R A L A N D S E L E C T I V E P G F 2 Α R E C E P T O R A N TA G O N I S T F O R
PRETERM LABOR (PTL)
OBE022
Well-characterized MOA, Strong pre-clinical/Phase 1 safety
At a Glance Dosing Profile Target Markets
• Prostaglandin F2α (FP) • Targeting myometrium • Preterm labor (GA 24-34
receptor antagonist contractions, cervix dilation, weeks) incidence
membrane rupture, • US ~ 500K
• Licensed from Merck Serono inflammatory processes • EU ~ 500K
• Composition of matter • Asia ~ 6.9M1
• Current treatments limited
protection through 2037 with efficacy & restrictive safety • Economic burden for
PTE premature infants in the US
• Goal to delay labor by 2-7 ~$26B ($16.9B in infant
days to treat fetus for organ medical care)
protection
1 WHO ‘Born Too Soon: The Global Action Report on Preterm Birth’ (2012)
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 30OBE022
P R O L O N G P H 2 A S T U D Y ( PA R T S A A N D B )
Preliminary safety Final Part A Main study end End of Infant FU
& PK analysis Main analysis
Part A Dosing for 7d Maternal + neonatal FU 24-month Infant FU
Up to 8 patients
Open-label: Atosiban + OBE022
Final Part B
Main analysis
Part B Dosing for 7d Maternal + neonatal FU 24-month Infant FU
up to 60 patients + up to 60 patients
• Double-blind: Atosiban + OBE022 vs Atosiban + PLACEBO
• Part A completed
• Part B began Q4:18
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 312019 FINANCIAL OUTLOOK
June 30 2019 Cash $98.5 million
Projected 2019 Cash Use $105-110 million
Expected Cash Runway Q4:20 with $75 million credit facility
2019 Investment Includes as many as 6 Phase 3 trials enrolling
Phase 3 data readouts for linzagolix and nolasiban
Getting started with nolasiban in U.S. and China
Phase 2 decision for OBE022
Pre-commercial nolasiban in EU
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 32O B S E VA – A U N I Q U E I N V E S T M E N T O P P O R T U N I T Y
• Multibillion USD opportunity
Deliver more IVF babies 3 Product candidates in 4 large indications
NOLASIBAN at lower cost Wholly-owned exclusive WW rights*
IP ≥ mid-2030 for all 3 product candidates
Effective without • Major catalysts in 2019
LINZAGOLIX hormone
replacement therapy Nolasiban IMPLANT 4 IVF Ph3 readout and MAA filing
Linzagolix PRIMROSE Fibroid Ph3 readout
OBE022 PROLONG PTL Ph2a readout
OBE022 Potential to save
newborn lives • NOLASIBAN – Expected first launch in EU (1Q 2021)
* Except for linzagolix Asia rights own by KISSEI
©2019 OBSEVA S.A. CONFIDENTIAL AND NOT FOR DISTRIBUTION. COPYING OF THIS MATERIAL BY ANY MEANS WITHOUT OBSEVA’S PRIOR WRITTEN CONSENT IS PROHIBITED. 33THANK YOU
September 2019
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