Slide 1: We aim to change pregnancy care
WE AIM to change pregnancy care, to transform the experience into one with fewer uncertainties.
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, future financial po
Slide 3: Rising maternal and neonatal mortality in the U.S.
In the U.S., maternal and neonatal mortality rates are increasing, signaling a need for improved healthcare and innovation. One-third of pregnant women experience complications, often without warning, posing significant health risks for both mother and child.
Slide 4: Vision and Mission
Vision Mission Sera Prognostics aims to be a global leader in high- value women’s health diagnostics, delivering pivotal information to physicians and mothers to improve the health of pregnant women and newborns, and to simultaneously improve the economics of pregnancy care. Pregnancy complications
Slide 5: The Pregnancy Company
The Pregnancy Company® SPECIALTY LAB INNOVATIVE TESTS & PRODUCTS PREGNANCY OUTCOMES EMPOWERMENT RESEARCH- DRIVEN GLOBAL IMPACT Focuses on obstetric test offerings and analytics products Provides information to healthcare providers to guide personalized interventions Committed to driving advancements
Slide 6: Societal Impact
SOCIETAL IMPACT Focusing on neonatal and maternal outcomes can yield numerous benefits for all members of society Families: Decrease the burden linked to pregnancy complications Payers: Improve outcomes and the economics of care delivery Communities: Address growing health disparities in maternal ca
Slide 7: Improved pregnancy outcomes start with better information
Improved pregnancy outcomes start with better information Utilize proteomic testing early in the pregnancy to identify high-risk pregnancies Target individuals identified as high-risk for tailored preventive treatments Achieve healthier outcomes by reducing morbidity, mortality, and hospitalization
Slide 8: Why Proteomics?
Given the limitations of current screening practices for pregnancy complications, scientists at Sera discovered a biomarker prediction that fills a critical diagnostic gap. Why Proteomics? Personalized insights for each pregnancy. Proteomics provide insights into the biology of each pregnancy and go
Slide 9: Proprietary data assets and technology platform
Sera’s proprietary data assets and technology platform generate powerful insights Biobank of Blood Samples Clinical Outcomes Data Demographic & Geographic Diversity Advanced Mass Spectrometry Artificial Intelligence & Machine Learning Global Dataset 20,000 pregnant women Multiple clinical utility st
Slide 10: Transforming national averages into personalized insights
Sera’s technology platform transforms national averages into personalized insights The national risk of a complicated pregnancy is 31%. The probability of pregnancy complications range from 10 - 90%. Utilizing proteomic markers and data analytics, Sera can identify a mother’s pregnancy journey inclu
Slide 11: Near Term Execution: Accelerate PreTRM Adoption & Revenue
NEAR TERM EXECUTION Accelerate PreTRM Adoption & Revenue
Slide 12: Addressing the Problem of Preterm Birth
Addressing the Problem of Preterm Birth References: 1. Osterman MJK, Hamilton BE, Martin, J.A., Driscoll AKV, C.P. Births: Final Data for 2020. Division of Vital Statistics, National Center for Health Statistics, U.S. Centers for Disease Control and Prevention. 2022 Feb 7 (https://www.cdc.gov/nchs/n
Slide 13: Reducing health impacts of early delivery with the PreTRM Test
Reducing the health impacts of an early delivery with the PreTRM® Test Challenges facing risk assessment for preterm birth Knowing the Risk Enables Informed Action Reduce the impacts of preterm birth Up to half of all pregnant women who deliver prematurely have no known risk factors1,2 PreTRM’s sens
Slide 14: A strong foundation of evidence
A strong foundation of evidence C L I N I C A L S T U D I E S A N A L Y T I C A L V A L I D A T I O N C L I N I C A L V A L I D A T I O N C L I N I C A L U T I L I T Y E C O N O M I C U T I L I T Y CLINICAL MASS SPECTROMETRY / Bradford et al., 2017 • Achieved robust analytical validation of protein
Slide 15: New clinical utility evidence
Building on the foundation with new clinical utility evidence C L I N I C A L S T U D I E S A N A L Y T I C A L V A L I D A T I O N C L I N I C A L V A L I D A T I O N C L I N I C A L U T I L I T Y E C O N O M I C U T I L I T Y AVERT / Hoffman et al., 2023 PRIME / Iriye et al., ongoing Further inves
Slide 16: AVERT PRETERM Trial study design
Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker-guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503 The AVERT PRETERM Trial studied the health impacts of the PreTRM® t
Slide 17: AVERT results: 7 day reduction in hospital stay
Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker- guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503 Reduce the time the baby spends in the hospital on average by one
Slide 18: Severe morbidity and mortality significantly reduced
Severe morbidity and mortality rates were significantly reduced • 1-4 score given (4 = infant mortality) • The score increases by 1 point for each additional diagnosis of: • Respiratory distress syndrome • Bronchopulmonary dysplasia • Intraventricular hemorrhage grade III or IV • All stages of necro
Slide 19: AVERT results: increased gestational age at birth
Historical Arm (Standard of Care) N=155 Prospective (Test and Treat) N=15 Gestational Age at Birth <32 Weeks Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker- guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: h
Slide 20: AVERT results: 28 day reduction in length of stay
Reference: Matthew K. Hoffman, Carrie Kitto, Zugui Zhang, et al. Neonatal outcomes after proteomic biomarker- guided intervention: the AVERT PRETERM TRIAL. medRxiv 2023.09.13.23295503; doi: https://doi.org/10.1101/2023.09.13.23295503 Reduce the time the neonate spends in the hospital on average by o
Slide 21: PRIME Study & Real-World Evidence
Advancing PreTRM®’s Evidence Development for Enhanced Pregnancy Outcomes PRIME Study & Real-World Evidence Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs (PRIME) A pioneering clinical trial assessing the efficacy of the PreTRM Test and preventive int
Slide 22: Elevance economic utility study
Published Elevance Cost-Effectiveness Model Elevance Claims Data Results Analysis of >40,000 mothers and babies within commercially insured Elevance membership • Evaluated screening with PreTRM along with proactive interventions given to PreTRM-higher risk patients vs. standard care • Demonstrated r
Slide 23: Pregnancy Product Road Map
SERA Y PROGNOSTICS* Pregnancy Product Road Map
Slide 24: More than just the PreTRM Test
More than just the PreTRM® Test 2023 | 2024 | 2025 | 2026 | 2027 Commercially Available Estimated Product Launch P R E T R M T E S T P R E D I C T I V E A N A L Y T I C S P R O D U C T T I M E - T O - B I R T H T E S T P R E G N A N C Y R I S K P R E D I C T I O N P A N E L
Slide 25: Developing a portfolio to provide better answers
Developing a portfolio to provide better answers to life changing questions To provide a woman and her physician a risk assessment for spontaneous preterm birth To show a woman the most common outcomes in pregnancies of other women with similar clinical and demographic characteristics To provide a m
Slide 26: Robust Biomarker Pregnancy Pipeline
Robust Biomarker Pregnancy Pipeline PREDICTOR Est. U.S. Prevalence in Pregnancy PreTRM® Test for Risk of Preterm Birth Time-to-Birth Pregnancy Risk Prediction Panel Preeclampsia Predictive Analytics Product Fetal Growth Restriction (FGR) 10% 31% 5-8% N/A 3-7% DISCOVERY VERIFICATION VALIDATION COMMER
Slide 27: Technology Road Map
SERA Y PROGNOSTICS’ The Pregnancy Company” Technology Road Map fo) SERA 7 PROGNOSTICS* ® wee
Slide 28: Simplifying blood collection
Transitioning analyses for cost-effectiveness, faster turnaround times, and enhanced market accessibility • Diagnostic tests rely on biological samples, but there are current limitations on collection and transport • Sera is shifting to ambient conditions for sample transport to enhance the patient
Slide 29: Transitioning analyses to immunoassays
Transitioning analyses for cost-effectiveness, faster turnaround times, and enhanced market accessibility • Sera utilizes proteomic methods for discovering, verifying, and validating pregnancy tests. • The PreTRM® test, a prime example, is commercially launched using mass spectrometry, enabling swif
Slide 30: Sera Leadership Team
Sera Leadership Team Zhenya Lindgardt President & CEO • Former CEO, The Commons Project Foundation • Former VP of Platform and Customer Engagement, Uber Technologies • Former Senior Partner and Managing Director, The Boston Consulting Group • MBA, Harvard University Austin Aerts Chief Financial Offi
Slide 31: Thank You
Thank You a a