Sera Prognostics (SERA) 8-KSera Prognostics Reports Fourth Quarter 2023 Financial Results

WE AIM to change pregnancy care, to transform the experience into one with fewer uncertainties.

 

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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.

 

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 occur frequently, often without warning. In the U.S., this is the reality for one-third of pregnancies. Sera Prognostics is transforming the pregnancy journey with innovative products aimed at identifying complications early and accurately. We provide personalized insights into the risk of preterm birth and other pregnancy complications, empowering all pregnant women and their caregivers with innovative products aimed at delivering better outcomes for mothers and babies.

 

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 in maternal-fetal medicine through rigorous research and clinical trials Works towards shaping the future of pregnancy care worldwide Aims to empower expectant mothers with actionable insights Utilizes cutting-edge technologies such as proteomics and AI

 

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 care Healthcare Providers: Provide tools to address unmet needs in pregnancy care Self-insured Employers: Enhance employer healthcare for employees and their families Policy: Support government programs targeting improvements in maternal healthcare

 

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 time for newborns 1st Trimester 2nd Trimester 3rd Trimester Postpartum E N H A N C E D S C R E E N I N G P E R S O N A L I Z E D M E D I C I N E I M P R O V E D O U T C O M E S

 

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 beyond genetic inheritance. Early detection and intervention. Proteins reflect the functions of specific cells allowing for early detection and intervention before symptoms arise. Answers provided by proteomics.

 

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 studies Broad sample collection across U.S. population North America, Europe, Asia and Africa 300+ proteins analyzed Discovering important predictors POWERFUL INSIGHTS: • Early risk prediction such as preterm birth or preeclampsia, before symptoms manifest. • Improving health outcomes by identifying high-risk individuals and implementing targeted interventions • Shared decision-making by empowering patients to make informed decisions regarding prenatal care • Reduced healthcare costs through improvements in the health of the baby and reducing the need for the NICU • Research advancements to help understanding the biology of pregnancy

 

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 inclusive of her complication risk within a 4% margin. 31% 10% 90%to +/-4%

 

NEAR TERM EXECUTION Accelerate PreTRM Adoption & Revenue

 

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/nvss/births.html. 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. Howson CP, et al. Born Too Soon: Preterm birth matters. Reprod Health 10, S1 (2013). 4. Crump C, et al. Prevalence of Survival Without Major Comorbidities Among Adults Born Prematurely. JAMA. 2019 Oct 22;322(16):1580-1588. 1 10in babies are born too soon1 Preterm birth contributes to 34.2% of newborn deaths2 Causes numerous medical issues requiring more hospital time and pediatric visits3,4

 

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 sensitivity of 88% allows healthcare providers to detect higher-risk patients who would have been missed with current screening tools3 Recent studies demonstrated an 18% reduction in severe neonatal morbidity and mortality when higher-risk pregnancies identified by the PreTRM Test received risk- reduction interventions compared to standard care4 1. Institute of Medicine Committee on Understanding Premature Birth and Assuring Healthy Outcomes. Preterm Birth: Causes, Consequences, and Prevention. Behrman RE, Butler AS, eds. Washington (DC): National Academies Press (US) 2. Iams JD, et al. Prevention of Preterm Parturition N Engl J Med 2014;370:254-61. DOI: 10.1056/NEJMcp1103640 3. Burchard, J., et al. Better Estimation of Spontaneous Preterm Birth Prediction Performance through Improved Gestational Age Dating. J. Clin. Med. 2022, 11, 2885. https:// doi.org/10.3390/jcm11102885 4. 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

 

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 biomarkers for risk of spontaneous preterm birth PAPR / Saade et al., 2016 • AJOG editor’s choice establishing PreTRM® analytical validation ACCORDANT THRESHOLD / Burchard et al., 2021 AJP REPORTS / Caughey et al., 2016 • Empirical data demonstrating the clinical and cost impact of prognostic test for early detection of preterm birth • Validated PreTRM threshold for clinical decision-making for risk of spontaneous preterm birth (sPTB) and adverse maternal and neonatal outcomes in cohorts with diverse racial and ethnic backgrounds

 

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 investigates the value of implementing the PreTRM® test-and-treat strategy to reduce both adverse singleton pregnancy outcomes and overall healthcare costs PreTRM® test-and-treat strategy demonstrates statistically and clinically significant improvement in neonatal health outcomes and hospital length-of-stay PREDICTION AND PREVENTION OF PTB / Combs et al., 2023 Study concludes that screening with the PreTRM® Test followed by care management intervention and LDA prolonged pregnancy and reduced adverse outcomes ACCORDANT CU (TREETOP) / Burchard et al., 2022 Combines real-world observational data with simulation to project significant potential improvements in neonatal outcomes among racially and ethnically diverse populations PREVENT / Branch et al., 2021 Study demonstrates positive impact of the company’s PreTRM® test-and-treat strategy on improving neonatal healthcare COST-EFFECTIVENESS OF A PROTEOMIC TEST FOR PRETERM BIRTH PREDICTION / Grabner et al., 2021 Showed both improved neonatal outcomes and reduced immediate and long-term treatment costs associated with premature birth, when compared to routine care

 

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® test-and-treat Strategy • The study took place from June 2018 - September 2020 at ChristianaCare Hospital (Newark, DE) • The proportion of Black women in both arms was 26.5%, reflecting the racial diversity in the study site’s patient population Neonatal outcomes after proteomic biomarker guided intervention: the AVERT PRETERM TRIAL Study Design Historically Controlled Care management Daily open label vaginal progesterone 200mg Daily aspirin 81mg Screened with the PreTRM® Test Historical Controls Low Risk High Risk Treated with Interventions N=286 Normal Care N=953 Historical Controls N=10,000

 

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 week 7 Day Reduction in neonatal hospital length of stay AVERT Study Results

 

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 necrotizing enterocolitis • Periventricular leukomalacia • Proven severe sepsis • The scale uses NICU stays to determine index scores if the length of stay gives a higher score than concomitant diagnoses: 1-4 days give a score of 1, 5-20 days a score of 2 and >20 days a score of 3.1 *Severe neonatal morbidity and mortality are defined as Neonatal Composite Morbidity & Mortality Index (NMI) ≥3 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 NMI scores were significantly reduced in the prospective arm vs the historical arm (OR 0.81; 95% CI 0.67-0.98; P=0.03) 18% reduction in severe neonatal morbidity and mortality* (probability of NMI ≥ 3) 18% REDUCTION AVERT Study Results

 

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: https://doi.org/10.1101/2023.09.13.23295503 Increase gestational age at birth to improve outcomes for those at risk of earliest delivery 2.48 Weeks Increased Gestational Age at Birth on Average by 27.46 (weeks) 29.93 (weeks) Mean Gestational Age at Birth (weeks) AVERT Study Results

 

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 one month for those at risk of earliest delivery 28 Day Reduction in neonatal length of hospital stay for patients born before 32 weeks’ gestation Neonatal length of hospital stay (days) for babies born <32 weeks’ gestation P ro p o rt io n o f N e o n a te s R e m a in in g i n t h e H o s p it a l Neonatal Hospital Length of Stay (days) Cox PH P = 0.046 AVERT Study Results

 

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 interventions in lowering the occurrence of adverse pregnancy outcomes. Achievement of a primary endpoint resulted in the early termination of the 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 robust clinical and economic impacts of the PreTRM test-and-treat strategy • 20% reduction in preterm birth rates • $1,608 gross savings, excluding a $745 PreTRM list price per pregnant woman (amortized over all pregnancies including non-tested) • 10% reduction in neonatal intensive care admissions • 7% reduction in overall hospital length-of-stay • 33% reduction in births <32 weeks • The test-and-treat strategy is dominant with respect to cost savings across all conservative probabilistic sensitivity analyses and scenarios Economic Utility Study

 

Pregnancy Product Road Map

 

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

 

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 more accurate estimate of when a mother’s baby will be delivered for the purposes of planning maternity leave, travel, visitors, etc. This is a lifestyle and wellness test rather than a clinical test. To provide a woman and her physician a risk assessment for multiple pregnancy complications assessing both High Risk (rule-in) and Low Risk (rule-out) results in a single test PreTRM® Test Predictive Analytics Product Time-to-Birth Test Pregnancy Risk Prediction Panel Test Am I at risk for a premature birth? What do pregnancies like mine look like? When will my baby be born? Am I at risk for the common pregnancy complications?

 

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 COMMERCIALIZED Upcoming Expected Milestones and Anticipated Timing • Publications of additional clinical and economic outcome studies in 2024-2025 • PRIME: interim analysis complete; final in late 2024 • Publication of data in 2024-2025 • Validation underway to assess which risk factors and other major pregnancy complications to be included; began market research • Public release of validationdata in 2024 • Product profile development underway • Early market testing in progress • Biomarker discovery completed • Product profile development underway N/A

 

Technology Road Map

 

 

 

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 Officer • Former VP, Finance and Corporate Controller, Sera • Former finance team member, Myriad • Former auditor, Ernst & Young LLP • Master of Accounting University of Utah; CPA Jay Boniface, Ph.D. Chief Scientific Officer Robert G. Harrison Chief Information Officer Benjamin Jackson General Counsel Paul Kearney, Ph.D, Chief Data Officer Michael Foley, M.D. Medical Advisor Doug Roach VP of Commercial

 

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