powerpoint presentation · women in the u.s. are treated annually for fibroids. 10. linzagolix ....

M a y 2 0 2 0

2

D ISCLAIMER

Matters discussed in this presentation may constitute forward-looking statements. The forward-looking statements contained in thispresentation reflect our views as of the date of this presentation about future events and are subject to risks, uncertainties, assumptions, andchanges in circumstances that may cause our actual results, performance, or achievements to differ significantly from those expressed orimplied in any forward-looking statement. Although we believe that the expectations reflected in the forward-looking statements arereasonable, we cannot guarantee future events, results, performance, or achievements. Some of the key factors that could cause actualresults to differ from our expectations include our plans to develop and potentially commercialize our product candidates; our planned clinicaltrials and preclinical studies for our product candidates; the timing of and our ability to obtain and maintain regulatory approvals for ourproduct candidates; the extent of clinical trials potentially required for our product candidates; the clinical utility and market acceptance of ourproduct candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position; and ourability to identify and in-license additional product candidates. For further information regarding these risks, uncertainties and other factorsthat could cause our actual results to differ from our expectations, you should read our Annual Report on Form 20-F for the year endedDecember 31, 2019, as filed with the Securities and Exchange Commission on March 5, 2020 and our other filings we make with theSecurities 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 sellor 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 oreffectiveness for the purposes for which it is being investigated. The trademarks included herein are the property of the owners thereof andare 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 growthand other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undueweight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of themarkets in which we operate are necessarily subject to a high degree of uncertainty and risk.

3

FOCUSED ON UNMET NEEDS IN WOMEN’S HEALTH

LINZAGOLIX OBE022

Potential to delay preterm birth to improve newborn health and

reduce medical costs

Potential to relieve symptoms from heavy menstrual bleeding due to uterine fibroids and pain associated with endometriosis

NOLASIBAN

Potential to improve live birth rate following IVF & ET

4

PHASE 1 PHASE 2 PHASE 3 MARKET SIZE MILESTONES

LINZAGOLIX(OBE2109)Oral GnRH receptor antagonist

~4M women diagnosed and treated in the U.S.

Positive 24W primary endpoint results Q4:19, 52W results expected Q2:20

24W primary endpoint data expected Q2:20

MAA/NDA: Q4:20 / 1H::21

~5M women diagnosed and treated in the U.S.

Ph3 trials initiated Q2:19

Enrollment of new patients placed on voluntary hold Q1:20 amid COVID-19 pandemic

Positive Phase 2b results in 2018/19

OBE022Oral PGF2αreceptor antagonist

500,000 annual cases in both the U.S and Europe

Phase 2a results expected2H:20

Pre-clinical/Phase 1 complete

NOLASIBANOral oxytocinreceptor antagonist

Resuming development>2M IVF Global cycles/year

IMPLANT 2 Ph3 met primary & secondary endpoints

IMPLANT 4 Ph3 missed primary endpoint

YuYuan BioScience (PRC): IND submission 2H:20 in China

MULTIPLE PROGRAMS TO INNOVATE AND DRIVE VALUE

* Primary and secondary endpoints met

Uterine Fibroids – Ph3 PRIMROSE 1 U.S.

Preterm Labor – Ph2a PROLONG

IVF – Ph3 IMPLANT 2/4 EU

Uterine Fibroids – Ph3 PRIMROSE 2 EU & U.S. *

Endometriosis – Ph3 EDELWEISS 2 U.S.

Endometriosis – Ph3 EDELWEISS 3 EU & U.S.

Endometriosis – Ph2b EDELWEISS*

Preterm Labor – Ph1

IVF – Ph 1/2 in China

5

52020 MAJOR CATALYSTS

COVID-19: Top priority is safety of patients, employees, healthcare professionals Voluntary hold on enrollment of new patients in Phase 3 EDELWEISS trials No impact on timing of PRIMROSE or PROLONG trial readout

Phase 3 linzagolix trials in uterine fibroids 12 month PRIMROSE 2 and 6 month primary endpoint PRIMROSE 1 readout in Q2:20 MAA filing planned late 2020

Phase 2a OBE022 in preterm labor PROLONG PART B readout in 2H:20

Linzagolix regional commercial partnership 2020 corporate objective Maximize best in class potential

Nolasiban development in IVF proceeding in China Partner YuYuan Bioscience submitting IND 2H:20 Assessing higher and longer exposure to nolasiban

Linzagolix (OBE2109)

D O S E - D E P E N D E N T E S T R O G E N S U P P R E S S I O N TO T R E AT U T E R I N E F I B R O I D S A N D E N D O M E T R I O S I S

7

L INZAGOLIXD O S E - D E P E N D E N T R E D U C T I O NO F E S T R O G E N TO T R E AT U T E R I N EF I B R O I D S & E N D O M E T R I O S I S GnRH

Uterus

2. Prevents receptor activation by endogenous GnRH

1. Linzagolix binds competitively to pituitary gland GnRH receptors

4. Gonadotropin suppression leads to dose-dependent decrease in serum estradiol concentration

Anterior pituitary

gland

Hypothalamus

3. Rapid suppression of LH and FSH

Ovary

FSH, LH

Estradiol

Linzagolix

8

L INZAGOLIXO P T I M A L P R O F I L E TO A C H I E V E C L I N I C A L O U T C O M E SW I T H O N C E - D A I LY D O S I N G

Note: The data on this page are not from head-to-head comparisons.* ABT is not co-formulated with linzagolix to allow for use with or without according to physician choice; ** ABT is co-formulated with relugolix

Linzagolix Orilissa (Elagolix) Relugolix

Dose options

Endometriosis 75 mg

200 mg with ABT*

150 mg

200 mg BID without ABT40 mg with ABT**

Uterine Fibroids100 mg

200 mg with ABT*300 mg BID with ABT 40 mg with ABT**

Dosing frequency / day QD QD or BID QD

PK Characteristics

Half-Life 14-15 hours 2-6 hours 37-42 hours

Bioavailability > 80% 30 – 50% 11%

Food Effect No No Yes

CYP3A4 induction(ABT, contraception) No Yes No

9

UTERINE F IBROIDS A L A R G E M A R K E T W I T H U N M E T N E E D

Total U.S. costs estimated at up to

from direct costs, lost workdays and complications

$34B /yr9million

women in the U.S. suffer from fibroids

70%+of women have

fibroids by age 50

Qualityof Life

Premenopausal women may experience heavy menstrual bleeding, anemia, bloating, infertility, pain and swelling

600,000Hysterectomies are performed

annually in the U.S.

300,000Are because of uterine fibroids

> 4millionwomen in the U.S. are

treated annually for fibroids

10

L INZAGOLIX D E L I V E R I N G T H E F U L L P O W E R O F T H E G n R H A N TA G O N I S T C L A S S

The only GnRH antagonist offering two dosing options to treat MORE women with uterine fibroids

Linzagolix 200 mg with ABT, first choice for its outstanding efficacy

Linzagolix 100 mg without ABT, first choice when ABT is a potential safety, tolerability or preference issue*

1

2

* Thromboembolic history or risk, CV history or risk , breast cancer history or risk, intolerance to ABT, patient preference, …

11

PRIMROSE 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

The trial was powered under the assumption of a 30% placebo response rate based on historical studies

PRIMROSE 1100% U.S. sites

PRIMROSE 270% European sites30% U.S. sites

Main Study (N=500, 100/arm) Follow up

24 Weeks

Primary Endpoint:Responder-HMB Reduction

Q4:19/Q2:20

Placebo + placebo add-back

100 mg + placebo add-back

100 mg + add-back


200 mg + add-back



100 mg + add-back


200 mg + add-back

28 Weeks24 Weeks

Screening

Screening Follow-up100 mg + add-back

200 mg + add-back

100mg + placebo add-back

200 mg + add-back

200 mg + add-back

Follow-up100 mg + add-back

200 mg + add-back


200mg + add-back

200 mg + add-back


8-14 Weeks

Aiming to support the registration of two regimens of administration

12

PRIMROSE 2 D E M O G R A P H I C A N D B A S E L I N E C H A R A C T E R I S T I C S

* Anemia = hemoglobin value is less than 12.0 g/dL** MBL: Menstrual Blood Loss – upper limit of normal is 80 mL/month

Full Analysis Set

Placebo

n=102

Linzagolix100 mg

n=97

Linzagolix100 mg + ABT

n=101

Linzagolix200 mg

n=103


n=98

Total

n=501

Age (years) - mean (SD) 42.9 (5.3) 43.4 (5.4) 42.5 (5.1) 42.7 (5.8) 43.1 (4.8) 42.9 (5.3)

BMI (kg/m2 ) - mean (SD) 26.83 (5.42) 27.44 (5.67) 27.22 (5.82) 26.82 (5.55) 26.80 (5.47) 27.02 (5.57)

Hb < 10 g/dL – n(%) 14 (13.7) 21 (21.6) 16 (15.8) 18 (17.5) 24 (24.5) 93 (18.6)

Hb < 12 g/dL – n(%)* 51 (50.0) 61 (62.9) 59 (58.4) 57 (55.3) 56 (57.1) 284 (56.7)

MBL** (mL) at baselinemean (SD) 218 (128) 246 (161) 193 (92) 219 (136) 212 (142) 218 (134)

95% Caucasian / 5% Black

13

PRIMROSE 2P R I M A RY E N D P O I N T A C H I E V E D F O R B O T H TA R G E T D O S I N GR E G I M E N S – R E S P O N D E R * A N A LY S I S

Error bars are 95% CI

* Primary endpoint is the proportion of women with menstrual blood loss ≤ 80 mL (by alkaline hematin method) and ≥ 50% reduction from baseline

PRO

POR

TIO

N O

F W

OM

EN

100

80

60

40

20

0

29.4%

56.7%

93.9%

Placebo Linzagolix 100mg

Linzagolix 200mg + ABT

P

14

PRIMROSE 2 S I G N I F I C A N T A M E N O R R H E A * R AT E F O R B O T H TA R G E T D O S E S

Note: Error bars are 95% CI

PRO

POR

TIO

N O

F W

OM

EN

WIT

H A

MEN

OR

RH

EA

100

80

60

40

20

0 11.8%

34.0%

80.6%

Placebo Linzagolix100mg

Linzagolix200mg + ABT

p

15

KEY SECONDARY ENDPOINTS ACHIEVED

Key Secondary Endpoints Measurement p-value

Reduction in menstrual blood loss

• Time to reduced menstrual blood loss (i.e., ≤80 mL and ≥50% reduction from baseline) up to Week 24

• Number of days of uterine bleeding for the last 28-day interval prior to Week 24

p < 0.001

p < 0.001

Amenorrhea • Percentage at Week 24• Time to amenorrhea up to Week 24

p < 0.001p < 0.001

Improvement in anemia • Hemoglobin level at week 24 in anemic subjects (defined as subjects with Hb < 12 g/dL at baseline)

p < 0.001

Reduction in pain • Change from baseline pain score at week 24 p < 0.001

Reduction in volume • Fibroid volume change from baseline at Week 24o 100mg without ABTo 200mg with ABT

• Uterine volume change from baseline at Week 24

p < 0.055p < 0.008p < 0.001

Improvement in quality of life • Change from baseline health-related quality of life (UFS-QoL*) at Week 24 p < 0.001

* UFS-QoL = Uterine Fibroids Symptoms and Health-Related Quality of Life questionnaire

16

PRIMROSE 2 PA I N R E D U C T I O N A N D PAT I E N T S AT I S FA C T I O N F O R B O T H TA R G E T D O S E S

Note: Error bars are 95% CI; * p

17

EFF ICACY DATA FROM RECENT TRIALS OF GnRH ANTAGONISTS IN UTERINE F IBROIDS

Source: Company information –Note: NR = not reported.² PRIMARY ENDPOINT: Proportion of women with menstrual blood loss ≤ 80 mL (by alkaline hematin method) and ≥ 50% reduction from baseline

Linzagolix Relugolix Elagolix

PRIMROSE 2 LIBERTY 1 LIBERTY 2 ELARIS 1 ELARIS 2

Mean Age (y) 43.1 41.3 42.1 42.6 42.5

Baseline Menstrual Blood Loss (mL per cycle) 212 229 227 238 229

DoseRegimen

200mg + ABTOnce daily

40mg + ABTOnce daily

300mg + ABTTwice daily

Responder² Rate (RR) (%) 93.9 73.4 71.3 68.5 76.5

Placebo-adjusted RR (%) 64.5 54.8 56.5 60.0 66.0

Amenorrhea (%) 80.6 52.3 50.4 48.1 52.9

Placebo-adjusted RR (%) 68.8 46.8 - 43.7 48.2

PainFibroid VolumeUterine VolumeMenstrual Blood LossAnemiaQuality of Life

NRNRNR

NRNRNR

Caution advised when comparing across clinical trials. Below data are not head-to-head comparison, and no head-to-head trials have been completed, nor are underway

18

SUMMARY OF ADVERSE EVENTS

Treatment emergent adverse events, n (%)

Placebo

n=105

Linzagolix100 mg

n=99


n=102

Linzagolix200 mg

n=104


n=101

Total

n=511

Subjects with at least one TEAE

47 (44.8) 50 (50.5) 45 (44.1) 62 (59.6) 51 (50.5) 255 (49.9)

Vascular disorders* 6 (5.7) 15 (15.2) 12 (11.8) 36 (34.6) 14 (13.9) 83 (16.2)

* Vascular disorders include hot flushes, hypertension, flushing, varicose veins

Most common TEAEs (>5%)

‒ Hot flushes (13.9%)‒ Anemia (10.4%)‒ Headache (6.8%)

19

PRIMROSE 2 TRIAL B M D % C H A N G E F R O M B A S E L I N E AT W E E K 2 4

Mean % change in BMD from baseline to 24 weeks

* ABT: Add Back Therapy (estradiol + norethindrone acetate)

-5

-4

-3

-2

-1

0

1

2

Lumbar Spine Total hip Femoral neck

200mg + ABT

200mg

100mg + ABT

100mg

Placebo

Error bars are 95% CIs

100mg 200mg + ABT

Patients in the trial received no vitamin D or calcium supplementation

20

PRIMROSE 2N O D I F F E R E N C E E X P E C T E D B E T W E E N G n R H A N TA G O N I S T SI N T E R M S O F B M D I M PA C T

Source: Company information.

PRIMROSE 2 –OVERALL

POPULATION*

PRIMROSE 1 US only*

ELARIS-I (EGX)

ELARIS-2(EGX)

LIBERTY 1(RGX)

LIBERTY 2(RGX)

Subjects (n) 501 526 308 283 255 254

Black (%) 5.2% 64.3% 68/66% 67/66% 42/41% 42/42%

Age (mean year/SD) 42.9 (5.3) 41.6 (5.9) 41/42 42/42 42/41 42/42

Weight (kg/SD) 74.06 (15.90) 91.48 (19.78)

BMI (mean /SD) 27.02 (5.57) 32.70 (6.84) 34/33 34/33 32/31 32/3124 Week BMD Change (%, spine) -1.31% - -0.76% -0.61% -0.36% -0.13%

* PRIMROSE Trials no Vitamin D/Calcium supplementation

• Blacks have higher BMD and are more resistant to BMD loss than Caucasians• Higher body weight and BMI are protective against BMD loss• Vitamin D/Calcium supplementation reduces BMD loss at 12 months by an estimated 0.5%*

Linzagolix Potentially Best Meets the Needs of Women and Clinicians

Market survey results

22

Method Discreet choice modeling based on the responses of 101 U.S. patients with symptomatic uterine fibroids

MARKET FEEDBACKW H AT M AT T E R S F O R U T E R I N E F I B R O I D S PAT I E N T S ?

Source: AplusA US patient research (n = 101), Oct-Dec 2019

Pain Reduction

Bleeding Reduction

Needfor ABT Amenorrhea

HotFlushes

DailyIntake

0.0 0.0 0.0 0.0 0.0 0.0

In 8 /10 pts

In 6 /10 pts

In 4 /10 pts

In 8 /10 pts

In 6 /10 pts

In 4 /10 pts

No need

Required

In 8 /10 pts

In 6 /10 pts

In 4 /10 pts

In 1 /10 pts

In 3 /10 pts

In 5 /10 pts

QD

BID

Gain in utility

values from the

least to the most

positive perceived

levels

The ‘full package’ is required to win1

ABT matters for women2

Rank ordered perceived incremental value of the tested component levels in UF patients choice

Utility values are calculated for each attribute level to express their perceived relative value for patients when choosing the UF treatment they would prefer to receive instead of the current/latest one

Nearly 1/3 of women suffering from HMB due to uterine fibroids would prefer to avoid ABT

23

MARKET RESEARCHW H AT M AT T E R S F O R C L I N I C I A N S ?

AplusA US clinician research (n = 131), Oct-Dec 2019

Method Discrete choice modeling based on the responses of 131 US gynecologists

Price is key driver1

Bleeding outranks pain2

Perceived incremental value of the tested components levels in UF treatment choice

YearlyCost

Bleeding Reduction

Pain Reduction

HotFlushes

Needfor ABT

DailyIntake

0.0 0.0 0.0 0.0 0.0 0.0

$5 000

$6 250

$7 500

$8 750

$10 000

In 8 /10 pts

In 6 /10 pts

In 4 /10 pts

No need

Required

In 8 /10 pts

In 6 /10 pts

In 4 /10 pts

In 1 /10 ptsIn 3 /10 pts

In 5 /10 pts

QD

BID

Gain in utility

values from the worst to

best perceived

levels ABT less influential3

Incremental utility values for each attribute are calculated for each attribute level to express the perceived incremental value for physicians when going from one level to the next one for this attribute when choosing a GnRH analogue

24

L INZAGOLIX S T U D Y R E S U LT S & M A R K E T S U RV E Y S C O N F I R M P O T E N T I A L B E S T- I N -C L A S S




1

2


25

ENDOMETRIOSISA N E M O T I O N A L LY A N D P H Y S I C A L LY PA I N F U L C O N D I T I O N

Total U.S. costs estimated at up to

$22B /yr5 million

women in the U.S. are treated annually for endometriosis

Qualityof LifePremenopausal women may experience pelvic pain, pain during intercourse and defecation, infertility and emotional distress

10%Endometriosis affects up to

in the general population

50% in the infertile population60% in patients with chronic pelvic pain

176 millionwomen worldwide suffer

from endometriosis

60%of women will feel symptoms

by age 16

26

L INZAGOLIX D E L I V E R I N G T H E F U L L P O W E R O F T H E G N R H A N TA G O N I S T C L A S S





1

2

27

0

20

40

60

80

100

120

25mg 50mg 75mg 100mg 200mg

(whiskers represent 10% / 90% percentile)

EDELWEISS PHASE 2BD O S E - D E P E N D E N T S U P P R E S S I O N O F E 2

Endometriosis PatientsWeek 24 Modeled E2 Data

Linzagolix Daily Dose (mg) for 24 Weeks

Linzagolix 75mg

Linzagolix200mg

E2 concentration

(pg/ml)

(whiskers represent 10% / 90% percentile)

Target Range

E2 range: Symptom relief without BMD harm

28

PHASE 2B EDELWEISS TRIALE N D O M E T R I O S I S PAT I E N T S

**BMD: Bone Mineral Density* Titration after 12 weeks based on E2 serum level at weeks 4 and 8

MAIN STUDY FOLLOW UP

Enrollment 328 patients, ~65/arm 50 sites in U.S. (n=177)14 sites in EU (n= 151)

PRIMARY ENDPOINT: VRS PAIN SCORE RESPONDER RATE

SECONDARY ENDPOINT: BMD**

8–14 WEEKS

LEAD-IN

50mg daily

100mg daily

200mg daily

75mg daily

75mg daily*

PLACEBO

12 WEEKS 12 WEEKS 24 WEEKS

50mg daily

200mg daily

75mg daily

*Titrated dose 50-100mg

100mg daily

OPTIONAL EXTENSION:6M + 6M FOLLOW-UP

FOLLOW-UP

29

PHASE 2B EDELWEISS TRIALK E Y D O S E S M E T E F F I C A C Y E N D P O I N T S

Potential point of differentiation as 75mg partial suppression dose is nearly as effective as

200mg full suppression dose

Overall Pelvic Pain (%) Responder (0-3 VRS)

28,50

68,258,3

78,9 84,1

Week 12 Week 24

Plc 75mg 200mg

Dysmenorrhea (%)

Non-menstrual Pelvic Pain (%)

Responder (0-3 VRS)

Responder (0-3 VRS)

34,5

61,570,8

56,3

77,3

Week 12 Week 24

Plc 75mg 200mg

37,1

58,572,9

47,7

72,7

Week 12 Week 24

Plc 75mg 200mg

***

*** ***

*

* p value

30

PHASE 2B EDELWEISS TRIAL S U S TA I N E D I M P R O V E M E N T I N O V E R A L L E N D O M E T R I O S I S S Y M P TO M S ( P G I C )

PGIC (%)% Much and very much improvement (%)

* p value

31

PHASE 2B EDELWEISS TRIAL 7 5 m g E F F E C T I V E W I T H O U T S I G N I F I C A N T LY A F F E C T I N G B M D

-4

-3

-2

-1

0

1

2

Lumbar Spine Total hip Femoral neck

200mg

100mg

75mg FD

50mg

Placebo

Mean % change in BMD from baseline to 24 weeks (12 weeks for placebo)

* ABT: Add Back Therapy (estradiol + norethindrone acetate)

75mg 200mg

Error bars are 95% CIs

32

PHASE 3 ENDOMETRIOSIS TRIALS E D E LW E I S S 2 A N D 3

MAIN STUDY FOLLOW UP

11±5 WEEKS 6 MONTHS TREATMENT 6 MONTHS EXTENSION STUDY 6 MONTHS

CO-PRIMARY ENDPOINT:DYS/ NMPP RESPONDER ANALYSIS

LEAD-IN

INITIATED 1H:19

200mg daily + ABT

75mg daily

PLACEBO

75mg daily

200mg daily + ABT

75mg daily

200mg daily + ABT

FOLLOW-UP

33

Differentiated regimen offering compelling

commercial proposition

LINZAGOLIX A S I G N I F I C A N T O P P O R T U N I T Y

LINZAGOLIX is the only GnRH antagonist intended to be developedas two different, SIMPLE & WELL TOLERATED regimens for both indications

Commercial launches in 2022

Potentially best-in-class GnRH antagonist

Large markets with significant unmet need in U.S.

~ 4M treated for heavy menstrual bleeding resulting from uterine fibroids ~ 5M treated for endometriosis associated pain

Best-in-class response for HMB control in uterine fibroids and pain control in endometriosis with full suppression option

Only option under development for women with uterine fibroids who cannot or do not want to take ABT in both indications

Convenient, oral, once-daily dosing

1

2

3

Strong IP: exclusivity beyond 2036

33

Commercialization through partnership under assessment

OBE022

P O T E N T I A L TO D E L AY P R E T E R M B I R T H TO I M P R O V E N E W B O R N H E A LT H A N D R E D U C E M E D I C A L C O S T S

35

PRETERM DELIVERY: L IFE ALTERING & COSTLY

Preterm birth is the

TREMENDOUS MEDICAL & SOCIETAL COST

1 in 10babies are born premature Prematurity related deaths in 2015

35

of death of children under 5 years of age

LEADING CAUSE

more than

1 million

Average cost for a preterm infant (U.S.)

$50K Average cost per survivor infant born 24-26 weeks

$195K

B A B I E S S U RV I V I N G P R E M AT U R E B I R T H FA C E G R E AT E R R I S K O F N E O N ATA L C O M P L I C AT I O N S A N D L I F E L O N G D I S A B I L I T I E S

U.S. economic burden

$26B+ $16.9B+ U.S. Infant medical

care costs

36

MODE OF ACTION OF PGF 2α RECEPTOR ANTAGONIST TO CONTROL PRETERM LABOR

PGE2 PGF2α

PGHS -1/2 = COX1/2

EP1EP3

EP2EP4 FP

PGH2

contractrelaxcontract

Selectively blocks the PGF2αreceptor

Has the potential to treat preterm labor with improved safety over NSAIDs

OBE022

UTERUS:

Phospholipids

Arachidonic Acid

x

37

OBE022P R O L O N G P H 2 A S T U D Y PA R T B

Study design:Double-blind, randomized Atosiban + OBE022 versus Atosiban + Placebo

24-month Infant FU

Q1:18

Final Part B: Main analysis

2H:20 2H:22

Endpoint:Complete 7 days of dosing without delivery

Main Study completion

~120 patients

Dosing: 7 days up to 60 patients

Followed thru delivery

Interim Update 60 patients

Interim Update 30 patients

IDMC Reviews

38

F INANCIAL OUTLOOK 2020/21 Achievements Key Milestones

M a r c h 3 1 , 2 0 2 0 C A S H :

$62 million

E X P E C T E D C A S H R U N WAY:

Q3:21 including credit facility

PRIMROSE 1 and 2 Completion Uterine Fibroid regulatory filings (EU & US) PROLONG readout Nolasiban phase 1 trial results

in China

Ongoing Activities EDELWEISS 2 and 3 continuation Nolasiban phase 2 initiation in China Preparing commercialization of linzagolix

through partnership(s)

F I R S T L I N Z A G O L I XC O M M E R C I A L L A U N C H :

EU Q1:22

Slide Number 1disclaimerFocused on unmet needs in women’s health�Multiple programs to innovate AND drive value2020 Major catalystsLinzagolix (OBE2109)Linzagolix�Dose-dependent Reduction�of Estrogen to Treat Uterine�Fibroids & Endometriosis Linzagolix�optimal profile to Achieve clinical outcomes�with once-daily dosingUterine fibroids �A Large Market With Unmet Need�Linzagolix �delivering the full power of the GnRH antagonist classPrimrose 1 & 2 �Phase 3 clinical trials for the Treatment of Uterine FibroidsPRIMROSE 2 �Demographic and Baseline CharacteristicsPrimrose 2�Primary endpoint achieved for BOTH target Dosing�Regimens – Responder* analysisPRIMROSE 2 �SIGNIFICANT Amenorrhea* rate for both target DOSES KEY SECONDARY ENDPOINTS ACHIEVEDPrimrose 2 �PAIN REDUCTION and patient satisfaction for BOTH target DOSES Efficacy data from Recent trials of GnRH antagonists in uterine fibroidsSUMMARY OF ADVERSE EVENTSPrimrose 2 trial �BMD % change FROM BASELINE at week 24PRIMROSE 2�No difference expected between GnRH antagonists�in terms of BMD impactLinzagolix Potentially Best �Meets the Needs of Women and CliniciansMarket feedback�what matters for uterine fibroids patients?MARKET RESEARCH�what matters for clinicians?Linzagolix �study results & market surveys confirm potential best-in-classEndometriosis�An emotionally and physically Painful conditionLinzagolix �delivering the full power of the GnRH antagonist classEDELWEISS Phase 2b�dose-dependEnt suppression of e2Phase 2b EDELWEISS trial�endometriosis patientsPhase 2b EDELWEISS trial�key doses met efficacy endpointsPhase 2b EDELWEISS trial �sustained improvement in overall endometriosis symptoms (PGIC)Phase 2b EDELWEISS trial �75mg effective without significantly affecting BMDPhase 3 Endometriosis trials �EDELWEISS 2 and 3Linzagolix �a significant opportunityOBE022Preterm DELIVERY: Life altering & costlyMode of action of Pgf2 receptor antagonist to control preterm laborOBE022�PROLONG Ph2a Study Part B financial outlook

powerpoint presentation · women in the u.s. are treated annually for fibroids. 10. linzagolix ....

Documents