Sera Prognostics, Inc. · NASDAQ:SERA

Sera Prognostics — Investor Presentation (January 2025)

34 slides from Sera Prognostics's investor presentation, Jan 13, 2025

  1. Slide 1: We at Sera aim to change pregnancy care

    ©2025 Sera Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States. In order to transform the experience into one with fewer uncertainties { WE AT SERA AIM TO CHANGE PREGNANCY CARE }

  2. Slide 2: 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 position, future revenue

  3. Slide 3: Preterm Birth is a Persistent Clinical & Economic Challenge

    Preterm Birth is a Persistent Clinical & Economic Challenge Preterm birth contributes to of newborn deaths2 Preterm birth causes numerous medical issues requiring more hospital time and pediatric visits4,5 References: 1. Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final

  4. Slide 4: Preterm Birth

    Preterm Birth References: 1. Martin JA, Hamilton BE, Osterman MJK. Births in the United States, 2022. NCHS Data Brief 2023; (477): 1-8.. 2. Callaghan WM, et al. The contribution of preterm birth to infant mortality rates in the United States. Pediatrics. 2006 Oct;118(4):1566-73. 3. Manuck TA, et al.

  5. Slide 5: Cost of preterm birth

    References: 1. Waitzman NJ, et al. Updating National Preterm Birth Costs to 2016 with Separate Estimates for Individual States: Final Report to the March of Dimes. Available from: marchofdimes.org/peristats/documents/Cost_of_Prematurity_2019.pdf 2. Phibbs CS, et al. Birth Hospitalization Costs and D

  6. Slide 6: Identifying patients at higher risk of preterm birth is a clinical challenge

    OF PREGNANT WOMEN who deliver prematurely have no known risk factors1 References: 1. Institute of Medicine Committee on Understanding Premature Birth and Assuring Healthy Outcomes. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press; 2007. 2. Iams JD, et al

  7. Slide 7: Sera discovered a biomarker risk predictor using proteomics

    Given the limitations of current screening practices for pregnancy complications, scientists at Sera discovered a biomarker risk predictor that fills a critical diagnostic gap Proteomics provide insights into the biology of each pregnancy and go beyond genetic inheritance Proteins reflect the functi

  8. Slide 8: Biologically important proteins are powerful predictors of spontaneous preterm birth

    ©2025 Sera Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States. Biologically important proteins are powerful predictors of spontaneous preterm birth, PreTRM® looks at each and their int

  9. Slide 9: PreTRM test is validated for prediction during weeks 18-20 of pregnancy

    SERA’S PRETRM® TEST IS VALIDATED FOR PREDICTION DURING WEEKS 18-20 OF PREGNANCY PAPR Validation Study1 (n=5501, 11 centers) The PreTRM® Test is highly predictive of spontaneous preterm birth with a single blood draw between 18 and 20 6/7 weeks of gestation2 Three Independent Studies (discovery, veri

  10. Slide 10: Our testing process integrates into women's health clinics

    Results delivered in an average of five days from a CLIA-certified, CAP-accredited lab Blood sample kits are provided for testing during 180/7-206/7 weeks with prepaid shipment to Sera’s lab Sample collection can be performed by staff and aligns with preexisting appointments ©2025 Sera Prognostics,

  11. Slide 11: The PreTRM Test kit contents

    KIT CONTENTS THE PRETRM® TEST The first of its kind to detect premature birth The PreTRM® Test predicts a patient’s individual risk of spontaneous preterm delivery in asymptomatic singleton pregnancies through a single blood draw performed during weeks 18 through 20 of gestational age. ©2025 Sera Pr

  12. Slide 12: Patients identified as higher risk by the PreTRM Test

    Patients identified as higher risk by the PreTRM Test are at increased risk for*: Final Communicates a patient’s risk of spontaneous preterm birth & helps physicians engage with patients TEST REPORT Spontaneous preterm birth Severe adverse neonatal outcomes Longer neonatal hospital length of stay Re

  13. Slide 13: Example clinical protocol

    Follow Patient with Regularly Scheduled Office Visits NO Is Patient <21 Weeks Gestation? Does Patient Meet PreTRM® Testing Criteria*? Provider Orders PreTRM® Blood Test Drawn at 18 Weeks to 20 Weeks-6 Days Results Sent to Provider Office Within 5 Days Do Test Results Show Higher Risk for Spontaneous

  14. Slide 14: Clinical Utility Validation

    Clinical Utility Validation PreTRM value has been demonstrated in multiple studies Biomarker Validation Studies PAPR Study (2016) 5,501 patients 11 sites Historical Controlled Trial AVERT PRETERM TRIAL (2024) 1,460 patients screened compared to 10,000 historical controls single site ©2025 Sera Progn

  15. Slide 15: The AVERT PRETERM Trial study design

    Neonatal outcomes after proteomic biomarker guided intervention: The AVERT PRETERM TRIAL STUDY DESIGN Care management Daily open label vaginal progesterone 200mg Daily aspirin 81mg Screened with the PreTRM® Test Historical Controls High Risk Treated with Interventions N=279 (mITT and ITT) Normal Car

  16. Slide 16: AVERT study results: reduced hospital stay

    AVERT STUDY RESULTS PreTRM helped reduce the length of time a baby spent in the hospital on average by one week Reference: Hoffman MK, Kitto C, Zhang Z, Shi J, Walker MG, Shahbaba B, Ruhstaller K. Neonatal Outcomes after Maternal Biomarker-Guided Preterm Birth Intervention: The AVERT PRETERM Trial.

  17. Slide 17: AVERT study results: morbidity and mortality reduced

    0-4 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 necrotizing enterocolitis Periventricular leukomalacia Proven severe sepsis *Seve

  18. Slide 18: Mother A without PreTRM, Mother B with PreTRM

    Mother A without PreTRM Mother B with PreTRM The PreTRM® Test is the first step to reduce the harms of preterm birth Medical Management Gestational Age at Birth Outcomes Time Spent in Hospital Standard care 30 0/7 weeks Necrotizing enterocolitis stage II/III Respiratory distress syndrome1 40 days1 W

  19. Slide 19: AVERT Study Results

    In the full mITT and ITT population neonates were discharged earlier from the hospital. NMI, significant in the full mITT primary analysis, remained significant in the full ITT population. NICU LOS was observed to be significantly reduced in the mITT and ITT populations. The number of patients neede

  20. Slide 20: PRIME study

    A pioneering clinical trial assessing the efficacy of the PreTRM Test and preventive interventions in lowering the occurrence of adverse pregnancy outcomes ©2025 Sera Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Progn

  21. Slide 21: PRIME randomized controlled trial design

    Care management Daily open label vaginal progesterone 200mg Daily aspirin 81mg Control Arm Full Analysis Set Not-Higher Risk Higher-Risk mITT Analysis Treated with Interventions Screened Arm The Randomized Controlled Trial Involved: 19 U.S. sites, including community practices and university-based o

  22. Slide 22: PRIME co-primary endpoints analysis

    TABLE 1 Modified intent-to-treat analysis of co-primary endpoints TABLE 2 Neonatal outcomes in the intent-to-treat population Variable Measure N Adjusted Rate (95% CI)* P NMI Odds Ratio 4468 0.75 (0.62-0.91) 0.003 NNLOS Hazard Ratio 437 0.82 (0.68-0.99) 0.044 NMI, neonatal morbidity index; NNLOS, ne

  23. Slide 23: Number Needed to Screen to prevent NICU admission

    Number Needed to Screen to prevent NICU admission is a critical metric of test performance for commercialization: PreTRM® Test shows powerful results The number of patients needed to screen (NNS) to improve a clinical outcome is a convenient and widely used metric that informs both the economic and

  24. Slide 24: Number Needed to Screen: widely adopted tests vs PreTRM

    Number Needed to Screen to prevent NICU admission is a critical metric of test performance for Commercialization: PreTRM® Test shows powerful results The number of patients needed to screen (NNS) to improve a clinical outcome is a convenient and widely used metric that informs both the economic and

  25. Slide 25: Economic value of PreTRM from a payer's perspective

    Economic value of PreTRM® from a Typical Fee-for-Service Payer’s Perspective Test costs $29,790 5 MILLION COVERED LIVES Source: Sera Economic Model leveraging inputs of costs of care from Elevance model: Burchard J, et al. Clinical and economic utility of a preterm birth predictor derived from an an

  26. Slide 26: Elevance Claims Data Results

    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 robust clinical and economic impacts of the PreT

  27. Slide 27: A physician shares a patient pregnancy story

    ©2025 Sera Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States. At a 6-week post-partum appointment, I walked into the exam room and my patient greeted me with a big smile and said… “I’

  28. Slide 28: Next Milestones

    Next Milestones Publications Commercialization: Driving Next Inflection Point Reimbursement Guidelines Regulatory Additional Evidence ©2025 Sera Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the Un

  29. Slide 29: Pathway to Reaching Commercial Inflection

    PRIME and AVERT Publications Awareness campaigns Early adopter cadre Institutional focus Awareness Building & Evidence Dissemination OUR FOCUS Pathway to Reaching Commercial Inflection Physician Demand & Early Payer Coverage Guidelines Inclusion Broad Payer Coverage & Reimbursement PRIME and AVERT P

  30. Slide 30: ACOG guidance and recommendation process

    Source: ACOG website, expert interviews. 1Gyamfi-Bannerman C , Thom EA , Blackwell SC , et al; NICHD Maternal–Fetal Medicine Units Network. Antenatal betamethasone for women at risk for late preterm delivery. N Engl J Med. 2016;374(14):1311-1320. doi:10.1056/NEJMoa1516783 Chronic Hypertension and Pr

  31. Slide 31: Sera's Strong Balance Sheet

    Q3 2024 earnings release highlights balance of ~$75M cash on Sera’s balance sheet Source: Sera Q3 2024 10Q. SERA’S STRONG BALANCE SHEET Sera cash position extends well into 2027 to support reaching seminal revenue inflection point ~$75M With <$30M annual operating spend, strong balance sheet allows

  32. Slide 32: Sera Leadership Team

    Sera Leadership Team Zhenya Lindgardt President & CEO • Former VP of Platform and Customer Engagement, Uber Technologies • Former Senior Partner and Managing Director, The Boston Consulting Group • Former CEO, The Commons Project Foundation • MBA, Harvard University Austin Aerts Chief Financial Offi

  33. Slide 33: Patient testimonial

    As a result of the weekly check-ins & overall care management, I was well-informed and empowered to advocate for myself and my baby. “ ” BONNIE Actual PreTRM® patient ©2025 Sera Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of

  34. Slide 34: Together, we can do better

    Educate Providers. Empower MOMS. HELP Babies. Advance Science. Elevate Care. Reach Maternity Deserts. Inform Payers. Evoke Change. TOGETHER, WE CAN DO BETTER ©2025 Sera Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Pro

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