Sera Prognostics, Inc. · NASDAQ:SERA
Sera Prognostics — Technical Presentation (March 2025)
25 slides from Sera Prognostics's technical presentation, Mar 19, 2025
Slide 1: Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions
o Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicenter Randomized Controlled Trial The PRIME Study Group PRIME STUDY Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal OutcoMEs
Slide 2: Declaration of Interests
Declaration of Interests • J.O. – Regional PI- Cofounder of company w/ interest in developing interventions to prevent PTB, patent on progesterone compounds for PTB prevention. • M. W. and B.S. – Statistical Consultants, received fees from the Sera Prognostics (sponsor) for work services provided •
Slide 3: Introduction
Introduction • Preterm birth results from multiple diverse etiologies Infection • Worldwide in 2020- 13.4 million preterm births with 900,000 infant Stress Uterine Distension/ deaths abnormalities • US- 10.4% PTB rate Preterm • Essentially unchanged rates over Birth the last decade Placental Cervica
Slide 4: Current Screening
Current Screening • Current screening is challenging as risk scoring systems fail to identify 50-60% of pregnancies who deliver preterm Davey MA, Watson L, Rayner JA, Rowlands S. Ferreira A, Bernardes J, Gonçalves H. PRIME STUDY Risk-scoring systems for predicting preterm Risk Scoring Systems for Pr
Slide 5: IGFBP4/SHBG Biomarker Screening
IGFBP4/SHBG Biomarker Screening • Insulin-like Growth Factor Binding Protein- 4/ Sex Hormone Binding Globulin- • Validated as a predictor for spontaneous PTB when drawn mid-2nd trimester • Testing may detect an issue, but can the results inform actionable decisions? Saade GR, Boggess KA, Sullivan SA
Slide 6: Methods
Methods PRIME STUDY Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal OutcoMEs
Slide 7: PRIME Trial
PRIME Trial • A 19-site multicenter RCT of low-risk patients for preterm birth– if knowledge of a blood biomarker test with targeted treatment for higher- risk participants improved neonatal outcomes • Inclusion criteria • 18 years old, informed consent • 18 0/7 weeks to 20 6/7, singleton • Screenin
Slide 8: PRIME Trial-Exclusion Criteria
PRIME Trial-Exclusion Criteria Pregnancy-Related Conditions Chronic Medical Conditions •History of spontaneous preterm birth (PTB) •Chronic medical diseases requiring intensive maternal •Short Cervix < 2.5 cm by TV sono surveillance, such as: •Major fetal anomaly or genetic abnormality • Systemic lu
Slide 9: Methods
Methods • Simple randomization of participants in 1:1 ratio control to prevention arm • Control arm- Results were blinded, underwent routine care • Prevention arm- Results disclosed to patients • Low-risk- no change in care outside of notification • Higher-risk- Targeted treatment bundle: LDASA 81 m
Slide 10: Co-Primary Outcomes
Co-Primary Outcomes • 1) Neonatal Morbidity and Mortality Index (adapted from Hassan, 2011). 0 No Morbidity No NICU Admission 1 1 event 1-4 NICU days 2 2 events 5-20 NICU days 3 3 events > 20 NICU days 4 Neonatal Mortality Morbidity event defined as: • RDS, BPD, IVH (grade 3 or 4), PVL, NEC, or cult
Slide 11: Co-Primary Outcomes
Co-Primary Outcomes • 2) Neonatal Length of Stay (Cox regression) • Measured in the most affected quantile of approximately 10% (longest stay) Both Co- Primary Outcome Variables utilized a mITT population • High-Risk Prevention Patients underwent 2nd informed consent and approved treatment • Started
Slide 12: Statistical Analysis/Power Analysis
Statistical Analysis/Power Analysis Sample size based on simulations employing a range of possible values for baseline risk, compliance, prevention bundle efficiency and patient retention Based on 29% screen + rate for biomarker testing, an estimated 5600 patients was needed PRIME STUDY Prematurity
Slide 13: Results
Results PRIME STUDY Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal OutcoMEs
Slide 14: Baseline characteristics
• No significant differences overall between groups at baseline • Diverse population • 27.6% on pre- enrollment LDASA
Slide 15: Antepartum and Delivery Characteristics
Antepartum and Delivery Characteristics All Control Prevention (n = 5018) (n = 2492) (n = 2526) • There was no difference in other characteristics around delivery except for a significant increase in corticosteroid administration in the control group • There was not a single cerclage performed in th
Slide 16: Co-Primary Outcomes Prevention Vs. Control
Co-Primary Outcomes Prevention Vs. Control Outcome OR /HR 95% CI P value Neonatal Morbidity 0.75 (0.62-0.91) 0.003 Index (NMI) a Neonatal Length of 0.82 (0.69-0.99) 0.044 Hospital Stay b a NMI was measured in the entire mITT population b Neonatal Length of hospital stay was measured in the most 10%
Slide 17: Full Analysis Set and Intent to Treat (ITT)
Full Analysis Set and Intent to Treat (ITT) • Full analysis set was the randomized ITT population without the 4.3% of patients missing neonatal data for the 2 co-primary outcomes (home delivery, change of hospital, other loss to f/u) • ITT is all patients (N=5018) with missing data analyzed by multi
Slide 18: Full Analysis Set (Prevention vs. Control)
Full Analysis Set (Prevention vs. Control) N OR/HR/IRR (95% CI) P value NMI 4756 0.80 (0.66-0.96) 0.015 Neonatal LOS 4757 0.91 (0.88-0.94) < 0.001 NICU LOS (admitted to NICU) 4759 0.92 (0.88-0.97) 0.003 NICU admission 4762 0.78 (0.65-0.93) 0.006 Intent to Treat (N= 5018) Prevention vs. Control
Slide 19: Gestational Age at Birth (Prevention vs Control)
Gestational Age at Birth (Prevention vs Control) PRIME STUDY Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal OutcoMEs
Slide 20: Conclusion
Conclusion • In a population of patients at low risk for preterm birth, a mid-trimester blood biomarker test used to screen and target treatment with an intervention bundle was associated with reduced neonatal morbidity and reduced neonatal hospital stays within the mITT population • The ITT populat
Slide 21: Study Strengths
Study Strengths • Multicenter trial • Diverse population • At low risk for singleton preterm birth (control arm 7.8% with US avg of 8.7%) • Improvements come from a low-risk and easily implemented bundle • Neonatal outcomes with clinically notable reductions • NMI- reduced 19-20% • NNLOS- reduced 8-
Slide 22: Number Needed to Screen (NNS)
Number Needed to Screen (NNS) PRIME Reductions NNS To prevent 1 NICU day 3.1 To prevent 1 NICU Admission 41 • Cervical length population screening • Accepted by multiple societies (ACOG, ISUOG) • NNS = 150. • Conde-Agudelo, Romero R. Am J Obstet Gynecol. 2016 Feb;214(2):235-242. PRIME STUDY Prematur
Slide 23: Limitations
Limitations • Co-primary evaluation in mITT population may overestimate effects • FAS and ITT mitigate these risks and provide better internal validity • Biomarker results were disclosed in the prevention arm • This may have affected treatment patterns in the high-risk arm of the prevention group wh
Slide 24: Summary
Summary • In this low-risk population, implementing a “screen and treat” strategy led to clinically meaningful reductions in neonatal adverse outcomes, underscoring its potential to strengthen maternal care and improve neonatal outcomes. • This strategy suggests the potential to ameliorate the medic
Slide 25: Combine with Results of Avert
Combine with Results of Avert NMI Neonatal Length of stay PRIME STUDY Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal OutcoMEs
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