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DISCUSSION AND ANALYSIS OF FINANCIALCONDITION AND RESULTS OF OPERATIONS. Statement
DID YOU KNOW? Preterm Birth is a Persistent Clinical & Economic
Challenge Preterm birth contributes to 1 in 10 The US rate rose from % BABIES 34.2 % % ARE BORN 9.6 to 10.4 1 2 3 TOO SOON of newborn deaths 2013-2023 4,5 Preterm birth causes numerous medical issues requiring more hospital time and pediatric visits
References: 1. Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2022. Natl Vital Stat Rep. 2024 Apr;73(2):1-56. PMID: 38625869. 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. March of Dimes 2024 report,. 4. Howson CP, et al. Born Too Soon: Preterm birth matters. Reprod Health 10, S1 (2013). 5. Crump C, et al. Prevalence of Survival Without Major
Preterm birth is a prevalent complication and a leading cause of
neonatal morbidity and mortality Preterm Birth Prevalence Mortality 1 2 Any birth before 37 weeks of gestation 10.4% in 2023 34.2% of newborn deaths are attributed to preterm birth 4 3 Median hospital length of stay by gestational week (Aetna)
Neonatal outcomes are dependent on gestational age at birth Major Morbidities: Persistent pulmonary hypertension; Intraventricular hemorrhage grade II/IV; Seizures; Hypoxic-ischemic encephalopathy; Necrotizing enterocolitis stage II/III;
Bronchopulmonary dysplasia Minor Morbidities: Intraventricular hemorrhage grade I/II; Necrotizing enterocolitis stage I; Respiratory distress syndrome; Hyperbilirubinemia requiring treatment; Hypotension requiring treatment References: 1. March of
Dimes 2024 report.. 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. Preterm neonatal morbidity and mortality by gestational age: a
contemporary cohort. Am J Obstet Gynecol. 2016;215(1):103. 4. Beam et al, Estimates of healthcare spending for preterm and low-birthweight infants in a commercially insured population: 2008-2016, Journal of Perinatology (2020) 40:1091-1099.
The health impacts of preterm birth drive increased expenditures, with
significant cost of care reductions as gestational age at birth increases 3 Expenditure distributions stratified by gestational age In the U.S., the cost to manage the complications of prematurity in 2016 was on average, $64,815 1 per preterm birth
The lifetime costs associated with preterm birth are estimated to be 10 times higher than those associated with a full-term 2 birth in the U.S. Preterm births account for 61% of neonatal costs 2 for in-hospital deliveries 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. 2. Phibbs CS, et al. Birth Hospitalization Costs and Days of Care for Mothers and Neonates in California,
2009-2011. J Pediatr. 2019 Jan; 204:118-125.e14. 3. Beam et al, Estimates of healthcare spending for preterm and low-birthweight infants in a commercially insured population: 2008-2016, Journal of Perinatology (2020) 40:1091-1099. 2025
Importantly, an 50% effective treatment to reduce PTB OF PREGNANT
" ACOG defined characteristics of should be available, WOMEN who deliver an effective screening program and the screening prematurely have no 1 program should be known risk factors feasible, cost- effective, and accessible to all IDENTIFYING
PATIENTS 2 patients. AT HIGHER RISK OF PRETERM BIRTH IS A CLINICAL CHALLENGE 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. American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Prediction and Prevention of Spontaneous Preterm Birth: ACOG Practice Bulletin, Number 234.
Prognostics, Inc. in the United States.
Given the limitations of current screening practices for pregnancy
complications, scientists at Sera discovered a biomarker risk predictor that fills a critical diagnostic gap Answers provided by PROTEOMICS Proteomics provide insights into the biology of each pregnancy and go beyond genetic inheritance Proteins
Sera Prognostics, Inc. in the United States.
Biologically important proteins are powerful predictors of spontaneous
preterm birth, PreTRM looks at each and their interaction Precise mass spectrometry measurements of proteins on blood drawn at 18-20 weeks are used algorithmically to generate a single probability score for preterm birth that is reported to
the ordering physician. 1. Sitar T, et al. Structural basis for the inhibition of insulin-like growth factors by insulin-like growth factor-binding proteins. Proc Natl Acad Sci USA 2006 103: 13028-13033. 2. Grishkovskaya I, et al. Resolution of a
logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States.
SERA'S PRETRM TEST IS VALIDATED FOR PREDICTION DURING WEEKS
18-20 OF PREGNANCY o The PreTRM Test is highly predictive of spontaneous preterm birth with a single blood 2 draw between 18 and 20 6/7 weeks of gestation PAPR o Three Independent Studies (discovery, verification, Validation validation)
reported in a large, multi-center trial 1 Study o Published as Editor's Choice article in American (n=5501, 11 centers) Journal of Obstetrics & Gynecology (May 2016) References 1. Saade GR, et al. development and validation of spontaneous
preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016;214:633e1-24. 2. Burchard, J., et al. Better Estimation of Spontaneous Preterm Birth Prediction Performance through Gestational Age Dating. J. Clin. Med. 2022, 11, 2885.
PreTRM was designed to screen women without obvious risk factors
for preterm birth After a physician places the order { OUR TESTING PROCESS SEAMLESSLY INTEGRATES INTO WOMEN'S HEALTH CLINICS } Blood sample kits are Sample collection can be Results delivered in an provided for testing performed by staff and
and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States.
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 collection performed during weeks 18 through 20 of gestational age. 2025 Sera
TEST REPORT Communicates a patient's risk of spontaneous preterm
birth & helps Final physicians engage with patients Pregnancies identified as higher risk by the PreTRM Test are at increased risk for*: Longer neonatal Spontaneous hospital length preterm birth of stay Severe adverse neonatal outcomes
*Reference: Burchard J, et al. Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study. J. Clin. Med. 2021, 10, 5088. doi: 10.3390/jcm10215088.
AS A RISK STRATIFICATION BIOMARKER TEST PreTRM identifies those
who may benefit most from targeted preterm birth interventions Follow Patient with Regularly Does Patient Meet PreTRM Testing Criteria*? NO *PreTRM TESTING Scheduled Office Visits CRITERIA o Single Fetus Provider Orders PreTRM Blood
Test Drawn at 18 Weeks to 20 Weeks-6 Days o No History of Preterm Birth o Unknown or Normal Cervical Length Results Sent to Provider Office Within 5 Days o Intact Membranes o No Signs of Preterm Labor Do Test Results Show Higher Risk NO for
Spontaneous Preterm Birth? YES TARGETED PROGESTERONE LOW-DOSE CARE MANAGEMENT ASPIRIN INTERVENTION SUPPLEMENTATION Refer patient to care management services for weekly phone Start daily vaginal progesterone Start LDA 81mg/day BUNDLE outreach &
assessment 200mg until 36 Weeks This is an example clinical protocol from a large integrated system. Sera does not give medical advice or endorse any specific protocol for any specific practice or patient. You should customize this document to fit
PreTRM value has been demonstrated in multiple studies Validation
Clinical Utility Historical Controlled Randomized Biomarker Validation Trial Controlled Trial Studies AVERT PRETERM TRIAL PRIME TRIAL (2025) PAPR Study (2016) (2024) 5,018 patients 5,501 patients 1,460 patients screened 19 sites 11 sites compared to
Neonatal outcomes after proteomic biomarker guided intervention: The
AVERT PRETERM TRIAL S T U D Y D E S I G N Screened with the Historical Controls PreTRM Test High Risk Low Risk The AVERT PRETERM Trial studied the health Treated with Declined Historical Normal Care Interventions Treatment N=939 Controls
(mITT and ITT) N=10,000 N=279 (mITT and ITT) N=214 (ITT) impacts of the PreTRM Care June 2018 - September 2020 test-and-treat strategy management ChristianaCare Hospital (Newark, DE) Black women comprised 26.5% of study participants,
reflecting racial diversity as Daily open label compared to the U.S. population vaginal progesterone The AVERT study characterized the benefits of the PreTRM test-and-treat 200mg strategy. mITT is used to assess whether the interventions themselves
work when compliance Daily aspirin 81mg has occurred with the treatment protocol. ITT analysis is used to estimate the impact of the strategy in study by evaluating the outcomes occurring in all patients, whether they Reference: Hoffman MK, Kitto C,
Zhang Z, Shi J, Walker MG, Shahbaba B, Ruhstaller K. Neonatal Outcomes after Maternal complied with the protocol or not. Biomarker-Guided Preterm Birth Intervention: The AVERT PRETERM Trial. Diagnostics. 2024; 14(14):1462.
AVERT STUDY RESULTS PreTRM helped reduce the length of time a baby
spent in the hospital on average by one week Neonatal length of hospital stay (days) for babies with the longest hospital stays Reduction in neonatal hospital length of stay Length of stay (days) 7 Days 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. Diagnostics. 2024; 14(14):1462. https://doi.org/10.3390/diagnostics14141462 2025 Sera Prognostics,
AVERT STUDY RESULTS Positive Impact on Neonatal Health Severe morbidity
and mortality rates were *Severe neonatal morbidity and significantly reduced mortality are defined as Neonatal Composite Morbidity & Mortality Index (NMI) 3 NMI scores were significantly 0-4 score given (4 = infant mortality) reduced in
the prospective The score increases by 1 point arm vs the historical arm for each additional diagnosis of: (OR 0.81; 95% CI 0.67-0.98; P=0.03) NMI Scores o Respiratory distress syndrome o Bronchopulmonary dysplasia o Intraventricular hemorrhage
grade III or IV 18% reduction in severe o All stages of necrotizing enterocolitis o Periventricular leukomalacia neonatal morbidity o Proven severe sepsis and mortality* 18% (probability of NMI 3) The scale uses NICU stays to determine index
scores Reduction 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 Reference: Hoffman MK, Kitto C, Zhang Z, Shi J, Walker MG, Shahbaba B,
PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States.
AVERT Study Results The AVERT study achieved statistically significant
reductions in neonatal length of stay (NNLOS)* and neonatal morbidity/mortality (NMI), its two co-primary outcomes, in the mITT and ITT population. 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 needed to screen
to reduce one NICU ** day was calculated to be between 3 and 4 The odds of PTB and sPTB at several gestational age cut-offs was either significantly reduced or showed a trend in the direction of benefit in both the mITT and ITT populations.
*Among those babies with the longest stays **Internal data on file NNLOS: Neonatal hospital length of stay NICU LOS: NICU length of stay GAB: Gestational age at birth NMI: Neonatal morbidity and mortality, evaluated using a composite index PTB:
Preterm birth sPTB: Spontaneous preterm birth mITT: Modified intent-to-treat ITT: Intent-to-treat Reference: Hoffman MK, Kitto C, Zhang Z, Shi J, Walker MG, Shahbaba B, Ruhstaller K. Neonatal Outcomes after Maternal Biomarker-Guided Preterm Birth
trademarks of Sera Prognostics, Inc. in the United States.
Imaginary Imaginary The PreTRM Test Mother A Mother B without
PreTRM with PreTRM is the first step to reduce the harms Risk of Singleton o Perceived as low-risk o Higher-risk result from Spontaneous o Normal cervical length the PreTRM Test of preterm birth Preterm Birth o No history of preterm birth Medical
Standard care o Weekly nurse calls Management o Daily open label vaginal progesterone 200mg AVERT OUTCOMES: o Daily aspirin 81mg o Increased gestational age at birth on average by 2.48 weeks 0/7 0/7 Gestational 29 weeks 31 weeks for babies born
before 32 weeks' 2 Age at Birth gestation) o 18% reduction in severe neonatal 2 morbidity and mortality) Outcomes o Necrotizing enterocolitis stage II/III o Respiratory distress syndrome 1 o Respiratory distress syndrome o An average of 28-day
reduction in neonatal hospital length of stay for babies born before 1 Time Spent 40 days 12 days 2 32 weeks gestation) in Hospital References: 1. Manuck TA, et al. Preterm neonatal morbidity and mortality by gestational age: a contemporary cohort.
Am J Obstet Gynecol. 2016;215(1):103. 2. 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. Diagnostics. 2024; 14(14):1462.
PRIME STUDY In 2024, Sera completed a pivotal multicenter national
trial: PRIME Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs (PRIME) A pioneering clinical trial assessing the efficacy of the Achievement of one or more PreTRM Test and preventive interventions in
trademarks of Sera Prognostics, Inc. in the United States.
PRIME TRIAL Study design of the Prematurity Risk Assessment Combined
with Clinical Interventions for Improving Neonatal Outcomes - ITT constitutes the full analysis Enrolled and Randomized set with multiple imputation of 1:1 N=5018 (ITT) missing outcomes. (n=5,018) The Randomized Controlled Trial Involved: Screened
Arm Control Arm 19 U.S. sites, including community practices and N=2526 N=2492 university-based or -associated medical centers From November 2020 - December 2023 Not-Higher Risk Higher-Risk N=1918 N=594 Full Analysis Set (FAS): Full Analysis
Set - FAS constitutes all participants and their neonates Full Analysis Set Full Analysis Set N=564 with complete data through follow-up. N=1852 N=2390 Treated with Interventions mITT Analysis mITT Analysis N=335 N=1808 N=2325 mITT= modified
intention-to-treat The mITT population includes all intention-to-treat participants: (1) for whom both co-primary outcomes are known; and (2) who have been randomized to o Care management the control arm or received a not-higher-risk test result in
the prevention arm, or consented to and initiated treatment, before 24 weeks and 0 days of o Daily open label vaginal gestation, after receiving a higher-risk test result in the prevention arm. progesterone 200mg Enrolled individuals who were
subsequently diagnosed with COVID-19 and o Daily aspirin 81mg evaluated in a hospital setting during pregnancy were also excluded from mITT analyses. Reference: Iriye, B.K. et al. Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted
PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States.
PRIME Study Participants' Characteristics (ITT) No
significant differences between arms for major clinical and demographic characteristics Diverse population 27-28% of subjects on pre-enrollment low-dose aspirin (independent of the bundled intervention) Reference: Iriye, B.K. et al.
Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicenter Randomized Controlled Trial. Presented at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting, Friday, January 31, 2025 (Abstract LB05).
Co-Primary Outcomes 1. Neonatal Composite Morbidity and Mortality Index