JP MORGAN January 2020 - ObsEva
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
JP MORGAN CONFERENCE January 2020
2 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.
3
F O C U S E D O N U N M E T N E E D S I N W O M E N ’ S H E A LT H
LINZAGOLIX OBE022 NOLASIBAN
Potential to relieve symptoms Potential to delay preterm birth Potential to improve live birth
from heavy menstrual bleeding to improve newborn health and rate following IVF & ET
due to uterine fibroids and pain reduce medical costs (repositioning)
associated with endometriosis
4
M U LT I P L E L AT E - S TA G E P R O G R A M S T O D R I V E VA L U E
PHASE 1 PHASE 2 PHASE 3 MARKET SIZE MILESTONES
LINZAGOLIX ~4M women diagnosed Positive 24W primary endpoint
Uterine Fibroids – Ph3 PRIMROSE 2 EU & U.S. * and treated in U.S. results
(OBE2109)
24W primary endpoint data
Oral GnRH Uterine Fibroids – Ph3 PRIMROSE 1 U.S. Q2:20
receptor antagonist
MAA/NDA: Q4:20 / Q1:21
~5M women diagnosed Initiated Ph3 in Q2:19
Endometriosis – Ph3 EDELWEISS 2 U.S.
and treated in U.S.
Endometriosis – Ph3 EDELWEISS 3 EU & U.S. Positive Phase 2b results in
2018/19
Endometriosis – Ph2b EDELWEISS
OBE022 Preterm Labor – Ph2a PROLONG *
500,000 annual cases in Interim update in 60 patients
each of U.S and Europe Q1:20
Oral PGF2α
receptor antagonist
Preterm Labor – Ph1
Pre-clinical/Phase 1 complete
NOLASIBAN IVF – Ph3 IMPLANT 2/4 EU
Resuming development Positive IMPLANT 2 Ph3 Results
Oral oxytocin > 2M IVF Global IMPLANT 4 Ph3 missed primary
receptor antagonist cycles/year endpoint
IVF – Ph 1/2 in China Partnership with Yuyuan
BioScience Technology (PRC)
* Primary and secondary endpoints met
5 2 0 2 0 C ATA LY S T S Multiple value driving catalysts in the upcoming year Two ongoing Phase 3 linzagolix trials in uterine fibroids to generate additional data starting in Q2:20 First linzagolix regulatory filing in uterine fibroids planned for late 2020 Phase 2 results of OBE022 expected in 2H:20 Corporate objective to establish commercial partnerships for Linzagolix that maximize compound value and prudently manage cash investments Resuming Nolasiban in IVF – YUYUAN Ltd (CHINA) partnership – aiming at assessing higher and longer exposure to nolasiban around embryo transfer in a potentially “enriched” IVF population
Linzagolix (OBE2109) OPTIMIZING APPROACH FOR R E D U C I N G E S T R O G E N T O T R E AT UTERINE FIBROIDS AND ENDOMETRIOSIS
7
LINZAGOLIX: DOSE-DEPENDENT REDUCTION OF ESTROGEN
T O T R E AT U T E R I N E F I B R O I D S & E N D O M E T R I O S I S
Validated MoA: Inhibition of endogenous GnRH signaling
Linzagolix binds competitively to
GnRH
pituitary gland GnRH receptors Hypothalamus
Prevents receptor activation by
endogenous GnRH Anterior pituitary gland
GnRH
‒ Induces neither downregulation nor antagonist FSH, LH
desensitization of the receptors
Immediate onset of action leads to
rapid, dose-dependent suppression of
gonadotropins, LH and FSH Estradiol Ovary
Gonadotropin suppression leads to a
dose-dependent decrease in blood
estradiol concentration
Uterus
8
LINZAGOLIX: PK PROFILE
Linzagolix Orilissa (Elagolix) Relugolix
75 mg 150 mg
Endometriosis 40 mg with ABT
200 mg with ABT 400 mg (200 BID) with ABT
100 mg
Dose options Uterine Fibroids 600 mg (300 BID) with ABT 40 mg with ABT
200 mg with ABT
Dosing frequency / day 1x 1x or 2x 1x
Half-Life 14-15 hours 2-6 hours 37-42 hours
Bioavailability > 80% 30 – 50% 11%
PK Moderate Major Major
Hepatic Elimination
Characteristics
Food Effect No No* Yes
CYP3A4 induction
No Yes No
(ABT, contraception)
Note: The data on this page are not from head-to-head comparisons.
* In a dedicated food effect study using a single 200 mg dose, there was a decrease of 24% and 36% in AUC and Cmax, respectively, under high-fat meal conditions; however, labelling states elagolix can be taken without regard to meals.
9
UTERINE FIBROIDS: A LARGE
MARKET WITH UNMET NEED
Total U.S. costs
estimated at up to
9 million 70%+
$34B
from direct costs, lost
/yr
women in the U.S.
suffer from fibroids
of women have
fibroids by age 50
workdays and complications
Quality
of Life
600,000
Hysterectomies are performed
annually in the U.S.
> 4 million
women in the U.S.
Premenopausal women may are treated annually
experience heavy menstrual
bleeding, anemia, bloating,
infertility, pain and swelling
300,000 for fibroids
Are because of uterine fibroids
10
MARKET FEEDBACK
W 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 ?
Method Discreet choice modeling based on the responses of 101 U.S. patients
with symptomatic uterine fibroids
Rank ordered perceived incremental value of the
tested component levels in UF patients choice
Pain Bleeding Need Hot Daily
Amenorrhea
Reduction Reduction for ABT Flushes Intake
In 8 /10
pts
The ‘full package’ is
In 8 /10 1
In 6 /10
pts No need
required to win
pts In 8 /10
pts In 1 /10
Gain in pts QD
ABT matters for
utility
values
In 6 /10
In 6 /10 2
from the
least to the
pts
pts
In 3 /10
women
most pts
positive
perceived
levels
0.0 In 4 /10 0.0 In 4 /10 0.0 Required 0.0 In 4 /10 0.0 In 5 /10 0.0 BID
pts pts pts pts
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
Source: AplusA US patient research (n = 101), Oct-Dec 201911
PRIMROSE 1 & 2: PHASE 3 CLINICAL TRIALS FOR THE
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
Primary Endpoint:
Responder-HMB Reduction
Main Study (N=500, 100/arm) Q4:19/Q2:20 Follow up
Placebo + placebo add-back
PRIMROSE 1
100% U.S. sites Placebo + placebo add-back 200mg + add-back
100 mg + placebo add-back 100 mg + placebo add-back
Screening 100 mg + add-back 100 mg + add-back Follow-up
200 mg + placebo add-back 200 mg + add-back
200 mg + add-back 200 mg + add-back
Placebo + placebo add-back 200 mg + add-back
PRIMROSE 2
70% European sites 100 mg + placebo add-back 100mg + placebo add-back
30% U.S. sites
100 mg + add-back 100 mg + add-back
Screening Follow-up
200 mg + placebo add-back 200 mg + add-back
200 mg + add-back 200 mg + add-back
8-14 Weeks 24 Weeks 28 Weeks 24 Weeks
Aiming to support the registration of two regimens of administration12
PRIMROSE 2: DEMOGRAPHIC AND BASELINE
CHARACTERISTICS
Linzagolix Linzagolix Linzagolix Linzagolix
Placebo 100 mg 100 mg + ABT 200 mg 200 mg + ABT Total
Full Analysis Set n=102 n=97 n=101 n=103 n=98 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 baseline
218 (128) 246 (161) 193 (92) 219 (136) 212 (142) 218 (134)
mean (SD)
95% Caucasian / 5% Black
* Anemia = hemoglobin value is less than less than 12.0 g/dL
** MBL: Menstrual Blood Loss13
PRIMROSE 2 PHASE 3 – UTERINE FIBROIDS
DOSE-DEPENDENT SUPPRESSION OF E2
Placebo Linzagolix 100 mg Linzagolix 100 mg + ABT
Linzagolix 200 mg Linzagolix 200 mg + ABT
120
Median serum E2 pg/mL
100
80
E2 range: symptom relief
without BMD harm
60
E2 Target Range 40
20
0
0 4 8 12 16 20 24
Weeks
ABT = Add Back Therapy (ActivellaTM )P R I M R O S E 2 – P 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 14
TA R G E T D O S I N G R E G I M E N S – R E S P O N D E R * A N A LY S I S
P15
K E Y S E C O N D A RY E N D P O I N T S A C H I E V E D
Key Secondary
Measurement p-value
Endpoints
Reduction in menstrual • Time to reduced menstrual blood loss (i.e., ≤80 mL and ≥50% p < 0.001
blood loss reduction from baseline) up to Week 24
• Number of days of uterine bleeding for the last 28-day interval prior p < 0.001
to Week 24
Amenorrhea • Percentage at Week 24 p < 0.001
• Time to amenorrhea up to Week 24 p < 0.001
Improvement in anemia • Hemoglobin level at week 24 in anemic subjects (defined as p < 0.001
subjects with Hb < 12 g/dL at baseline)
Reduction in pain • Change from baseline pain score at week 24 p < 0.001
Reduction in volume • Fibroid volume change from baseline at Week 24 for 100mg without p < 0.055/0.008
ABT and 200mg with ABT
• Uterine volume change from baseline at Week 24 p < 0.001
Improvement in • Change from baseline health-related quality of life (UFS-QoL*) at p < 0.001
quality of life Week 24
* UFS-QoL = Uterine Fibroids Symptoms and Health-Related Quality of Life questionnaire16
PRIMROSE 2: SIGNIFICANT AMENORRHEA RESPONSE
F O R B O T H TA R G E T D O S E S
p17
P R I M R O S E 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
Pain Reduction Patient Global Impression of Improvement
p=0.047 pR E C E N T T R I A L S O F G n R H A N TA G O N I S T S I N U T E R I N E F I B R O I D S 18
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
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
212 229 227 238 229
(mL per cycle)
Dose 200mg + ABT 40mg + ABT 300mg + ABT
Regimen Once daily Once daily Twice 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
Pain NR NR
Fibroid Volume NR NR
Uterine Volume NR NR
Menstrual Blood Loss
Anemia
Quality of Life
BMD Loss (%, Spine) -1.31 -0.36 -0.13 -0.76 -0.61
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 baseline19
S U M M A RY O F A D V E R S E E V E N T S
Placebo Linzagolix Linzagolix Linzagolix Linzagolix Total
Treatment emergent 100 mg 100 mg 200 mg 200 mg
adverse events, n (%) + ABT + ABT
n=105 n=99 n=102 n=104 n=101 n=511
Subjects with at least 47 (44.8) 50 (50.5) 45 (44.1) 62 (59.6) 51 (50.5) 255 (49.9)
one TEAE
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%)P R I M R O S E 2 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 20
C O N S I S T E N T W I T H I N D I C AT I V E R E F E R E N C E S
Placebo Linzagolix 100 mg Linzagolix 100 mg + ABT
Linzagolix 200 mg Linzagolix 200 mg + ABT
2 ELAGOLIX/MPA
“The absence of significant bone
loss was supported if the lower
from baseline BMD
bounds of the CIs for the mean
Mean % change
0 percentage change in BMD were
≥−2.2% for both the spine and
femur at week 24, which was
selected to reflect recommendations
-2 from the FDA (internal
communication)”*
-4
ELAGOLIX NDA Review 2018
“FDA considers BMD loss of ≤
3% to be within the variability of
-6 DXA measurement.”
Lumbar Femoral Total
spine neck hip
Patients in the trial received no vitamin D or calcium supplementation
* Carr B, Dmowski PD, O’Brien C, Jiang P, Burke J, Jimenez R, et al. Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone
acetate for the treatment of endometriosis: Effects on bone mineral density. Reproductive Sciences 2014; 21(11): 1341-51.21
P R I M R O S E 2 : B M D D ATA I N T E R P R E TAT I O N ( I )
Literature supports relationship between BMD, RACE & BMI
Race is one of the most important determinants of BMD
Blacks consistently reported to have higher BMD than other races1,2
‒ Unadjusted LS/FN BMDs 7-12% & 14-24% higher in black vs white women6
Caucasian race is a known risk factor for lower BMD and fracture3,4,5
Body weight and body mass index (BMI) are positively correlated with BMD
and protective against bone loss7-15
Low body weight or BMI is a risk factor for low bone mass and increased bone loss
In some studies, weight more predictive than BMI
LS=lumbar spine
FM=femoral neck
7Qiao D et al, Public Health 2019;180:22-28; 8Cao J, Journal of Orthopaedic Surgery and Research 2011; 6(30); 9Albala C et al, Int J
1Powe EC et al, NEJM 2013; 369(21); 2Looker AC et al, Osteoporos Int 2009; 20:1141–1149
3Cosman et al, Journal of Bone and Mineral Research. 2007; 22:S2; V34-38; 4Gourlay; J Bone
Obes Relat Metab Disord 1996; 20:1027–32; 10Asomaning K et al, J Women's Health 2006; 15:1028–34; 11Nielson CM et al, J Bone
Miner Res 2012; 27:1-10; 12Kim SJ et al; J Bone Metab 2012; 19(2):95-102; 13Finkelstein J et al; J Clin Endocrinol Metab 2008; 93(3);
Metab 2014; 21:61-68; 5Cauley JA et al, JAMA 2005; 293:2102-2108; 6Finkelstein J et al, J Clin
81-868; 14Lo J et al, Obstet Gynecol Clin N Am 2011; 38(3): 503-517; 15Dolan E et al, Nutrition Reviews 2017; 75(10):858-870
Endocrinol Metab. 2002; 87(7):3057-306722
P R I M R O S E 2 : B M D D ATA I N T E R P R E TAT I O N ( I I )
Study populations not similar for risk of BMD loss
PRIMROSE 2 –
PRIMROSE 2 PRIMROSE 1 ELARIS-I ELARIS-2 LIBERTY 1 LIBERTY 2
OVERALL
US Only US only (ELGX) (ELGX) (RLGX) (RLGX)
POPULATION
Subjects
(n)
501 48 526 308 283 255 254
Black
(%)
5.2% 52% 64.3% 68/66% 67/66% 42/41% 42/42%
Age
42.9 (5.3) 41.8 (5.6) 41.6 (5.9) 41/42 42/42 42/41 42/42
(mean year/SD)
Height
165.5 (6.1) 165.7 (6.8) - - - - -
(mean cm/SD)
Weight
74.06 (15.90) 91.48 (19.78) - - - - -
(mean Kg/SD)
BMI
27.02 (5.57) 33.29 (6.95) 32.70 (6.84) 34/33 34/33 32/31 32/31
(mean /SD)
PRIMROSE 1 trial – read-out 24 weeks – 2Q:20
In the overall population in the PRIMROSE 2 trial, the non-ABT group, BMD loss inversely related to BMI23
ENDOMETRIOSIS: AN
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
176 million 60%
$22B /yr
women worldwide suffer
from endometriosis
of women will feel
symptoms by age 16
Quality
of Life
Endometriosis affects up to
10% in the general
population
5 million
women in the U.S.
Premenopausal women may
experience pelvic pain, pain
during intercourse and
50% in the infertile
population
are treated annually
for endometriosis
defecation, infertility and
emotional distress 60% in patients with
chronic pelvic pain24
E D E LW E I S S P H A S E 2 B – Endometriosis Patients
ENDOMETRIOSIS: DOSE- Week 24 Modeled E2 Data
DEPENDENT SUPPRESSION
OF E2 E2
concentration
(pg/ml)
120 Linzagolix
75mg
100
Linzagolix
10% / 90% percentile) 200mg
E2 range: Symptom relief
(whiskers represent 80
without BMD harm
60
Target Range 40
20
0
25mg 50mg 75mg 100mg 200mg
Linzagolix Daily Dose (mg) for 24 Weeks
(whiskers represent 10% / 90% percentile)25
P 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 : Enrollment 328 patients, ~65/arm
50 sites in U.S. (n=177)
E N D O M E T R I O S I S PAT I E N T S 14 sites in EU (n= 151)
MAIN STUDY FOLLOW UP
PRIMARY ENDPOINT: SECONDARY ENDPOINT:
VRS PAIN SCORE RESPONDER RATE BMD** RESULTS:
JUNE 2018 SEPTEMBER 2018 1H 2019
PLACEBO
50mg daily 50mg daily
FOLLOW-UP
75mg daily 75mg daily
LEAD-IN
100mg daily 100mg daily
200mg daily 200mg daily OPTIONAL EXTENSION:
75mg daily* *Titrated dose 50-100mg 6M + 6M FOLLOW-UP
8–14 WEEKS 12 WEEKS 12 WEEKS 24 WEEKS
* Titration after 12 weeks based on E2 serum level at weeks 4 and 8 **BMD: Bone Mineral Density26
LINZAGOLIX PHASE 2B ENDOMETRIOSIS:
KEY DOSES MET EFFICACY ENDPOINTS
Dysmenorrhea (%)
Overall Pelvic Pain (%) Responder (0-3 VRS)
Responder (0-3 VRS) Plc 75mg 200mg
Plc 75mg 200mg 78,9 84,1
77,3 68,2
70,8 58,3
***
61,5 ***
56,3 28,5
** 0
34,5 *
Week 12 Week 24
Non-menstrual Pelvic Pain (%)
Responder (0-3 VRS)
Week 12 Week 24 Plc 75mg 200mg
72,9 72,7
58,5
47,7
Potential point of differentiation as 75mg partial suppression dose is 37,1 *
nearly as effective as 200mg full suppression dose
Week 12 Week 24
* p value27
P H A S E 2 B E D E LW E I S S T R I A L
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
Mean % change in BMD from baseline to 24 weeks (12 weeks for placebo)
Lumbar Spine Total hip Femoral neck
75mg 200mg
Placebo
50mg
75mg FD
-1.6% lower 100mg
bound Cl for
75mg 200mg
-3.6% lower
bound Cl for
200mg
Error bars are 95% CIs
* ABT: Add Back Therapy (estradiol + norethindrone acetate)28
LINZAGOLIX PHASE 3 ENDOMETRIOSIS TRIALS:
E D E LW E I S S 2 A N D 3
MAIN STUDY FOLLOW UP
CO-PRIMARY ENDPOINT:
DYS/ NMPP RESPONDER ANALYSIS
INITIATED 1H:19 75mg daily
PLACEBO 200mg daily + ABT
FOLLOW-UP
LEAD-IN 75mg daily 75mg daily
200mg daily + ABT 200mg daily + ABT
6 MONTHS TREATMENT 6 MONTHS EXTENSION STUDY
11±5 WEEKS 6 MONTHS29
LINZAGOLIX: A SIGNIFICANT OPPORTUNITY
LINZAGOLIX is the only GnRH antagonist intended to be developed
as two different, SIMPLE & WELL TOLERATED regimens for both indications
1 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
2 Potentially best-in-class GnRH antagonist
Best-in-class response for HMB control in uterine fibroids and pain
control in endometriosis with full suppression option
Differentiated regimen
Only option under development for women with uterine fibroids who
cannot or do not want to take ABT in both indications offering compelling
Convenient, oral, once-daily dosing commercial proposition
3 Significant revenue opportunity
IP protection beyond 2036OBE022 P O T E N T I A L T O D E L AY P R E T E R M B I R T H T O I M P R O V E N E W B O R N H E A LT H A N D REDUCE MEDICAL COSTS
31
P R E T E R M D E L I V E RY: L I F E A LT E R I N G & C O S T LY
Babies surviving early birth face greater likelihood of lifelong disabilities
Preterm labor is the
LEADING
CAUSE
of death of children
more
than 1in10 1million
babies are born premature
under 5 years of age premature deaths in 2015
Tremendous avoidable medical & societal cost
$50K $195K $26B+ $16.9B+
Average cost Average cost per U.S. U.S. Infant
for a preterm survivor infant economic medical
infant (U.S.) born 24-26 weeks burden care costs32
M O D E O F A C T I O N O F P G F 2 R E C E P T O R A N TA G O N I S T T O
CONTROL PRETERM LABOR
Phospholipids
Arachidonic Acid
PGHS -1/2 = COX1/2
Selectively Has the potential to
PGH2 blocks the treat preterm labor
OBE022 PGF2 with improved
receptor safety over NSAIDs
PGE2 PGF2
x
EP1 EP2
FP
EP3 EP4
UTERUS: contract relax contract33
O B E 0 2 2 : P R O L O N G P H 2 A S T U D Y PA R T B
Dosing: 7 days up Study design:
to 60 patients Double-blind, randomized Atosiban + OBE022
Followed thru delivery versus Atosiban + Placebo
Main Study
completion
120 patients
Interim Interim
Update Update
30 60 Endpoint:
patients patients Complete 7 days of dosing without delivery
Final Part B: Main analysis 24-month Infant FU
Q1:18 2H:20 2H:22
IDMC Reviews34
34
FINANCIAL OUTLOOK
2020
SEPTEMBER 30, 2019 CASH:
investment includes
$91 million FOUR ONGOING
Phase 3 trials:
E X P E C T E D C A S H R U N W AY:
Q1:21 with PRIMROSE 1
credit facility PRIMROSE 2
EDELWEISS 2
EDELWEISS 3You can also read
