powerpoint presentation · women in the u.s. are treated annually for fibroids. 10. linzagolix ....
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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.
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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
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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
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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
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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
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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
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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
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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
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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, …
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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 + placebo add-back
200 mg + add-back
Placebo + placebo add-back
100 mg + placebo add-back
100 mg + add-back
200 mg + placebo 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
100 mg + placebo add-back
200mg + add-back
200 mg + add-back
Placebo + placebo add-back
8-14 Weeks
Aiming to support the registration of two regimens of administration
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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
Linzagolix200 mg + ABT
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
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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
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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
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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
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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
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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
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SUMMARY OF ADVERSE EVENTS
Treatment emergent adverse events, n (%)
Placebo
n=105
Linzagolix100 mg
n=99
Linzagolix100 mg + ABT
n=102
Linzagolix200 mg
n=104
Linzagolix200 mg + ABT
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%)
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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
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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%*
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Linzagolix Potentially Best Meets the Needs of Women and Clinicians
Market survey results
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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
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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
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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
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, …
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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
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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
* Thromboembolic history or risk, CV history or risk , breast cancer history or risk, intolerance to ABT, patient preference, …
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 75 mg without ABT, first choice when ABT is a potential safety, tolerability or preference issue*
1
2
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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
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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
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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
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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
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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
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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
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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
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Commercialization through partnership under assessment
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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
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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
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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
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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
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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
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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