Slides
Page 1
©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 }
Page 2
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, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The company has no obligation to provide any updates to these forward-looking statements, even if its expectations change, whether as a result of new information, future events or otherwise, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the company’s Registration Statement on Form S-1, most recent Annual Report on Form 10-K, and/or subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the company’s other filings with the SEC. The information in this presentation should be considered in conjunction with a review of the company’s filings with the SEC including the information in the company’s Registration Statement on Form S-1, most recent Annual Report on Form 10-K, and/or subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIALCONDITION AND RESULTS OF OPERATIONS. Safe Harbor Statement
Page 3
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 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 Comorbidities Among Adults Born Prematurely. JAMA. 2019 Oct 22;322(16):1580-1588. ©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. The US rate rose from 9.4% to 10.4% 2013-20233 34.2% 1 in 10 BABIES DID YOU KNOW? ARE BORN TOO SOON1
Page 4
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. 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. Median hospital length of stay by gestational week (Aetna)4Neonatal outcomes are dependent on gestational age at birth3 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 Prevalence Mortality 34.2% of newborn deaths are attributed to preterm birth2Any birth before 37 weeks of gestation 10.4% in 20221 Preterm birth is a prevalent complication and a leading cause of neonatal morbidity and mortality ©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.
Page 5
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 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. In the U.S., the cost to manage the complications of prematurity in 2016 was on average, $64,815 per preterm birth1 The lifetime costs associated with preterm birth are estimated to be 10 times higher than those associated with a full-term birth in the U.S.2 Preterm births account for 61% of neonatal costs for in-hospital deliveries2 The health impacts of preterm birth drive increased expenditures, with significant cost of care reductions as gestational age at birth increases ©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. Expenditure distributions stratified by gestational age 3
Page 6
OF PREGNANT WOMEN who deliver prematurely have no known risk factors1 50% “ACOG defined characteristics of an effective screening program IDENTIFYING PATIENTS AT HIGHER RISK OF PRETERM BIRTH IS A CLINICAL CHALLENGE ©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. Importantly, an effective treatment to reduce PTB should be available, and the screening program should be feasible, cost- effective, and accessible to all patients.3 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. Prevention of Preterm Parturition N Engl J Med 2014;370:254-61. DOI: 10.1056/NEJMcp1103640 3. American College of Obstetricians and Gynecologists' Committee on Practice Bulletins—Obstetrics. Prediction and Prevention of Spontaneous Preterm Birth: ACOG Practice Bulletin, Number 234. Obstetrics Gynecol. 2021 Aug 1;138(2):e65-e90. doi: 10.1097/AOG.0000000000004479. PMID: 34293771.
Page 7
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 functions of specific cells allowing for early detection and intervention before symptoms arise Answers provided by PROTEOMICS ©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.
Page 8
©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 interaction 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 disordered region at the entrance of the human sex hormone-binding globulin steroid-binding site. J Mol Biol. 2002 318: 621-626. 3. Internal data on file. 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.
Page 9
SERA’S PRETRM® TEST IS VALIDATED FOR PREDICTION DURING WEEKS 18-20 OF PREGNANCY PAPR Validation Study1 (n=5501, 11 centers) o The PreTRM® Test is highly predictive of spontaneous preterm birth with a single blood draw between 18 and 20 6/7 weeks of gestation2 o Three Independent Studies (discovery, verification, validation) reported in a large, multi-center trial o Published as Editor’s Choice article in American 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. doi.org/10.3390/jcm11102885 ©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.
Page 10
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, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States. { OUR TESTING PROCESS SEAMLESSLY INTEGRATES INTO WOMEN’S HEALTH CLINICS } PreTRM® was designed to screen women without obvious risk factors for preterm birth After a physician places the order
Page 11
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 collection performed during weeks 18 through 20 of gestational age. ©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.
Page 12
Pregnancies 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 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. Available at https://www.mdpi.com/2077-0383/10/21/5088 ©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.
Page 13
Follow Patient with Regularly Scheduled Office Visits NO 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 Preterm Birth? NO 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 your practice and its treatment protocols. CARE MANAGEMENT Refer patient to care management services for weekly phone outreach & assessment PROGESTERONE SUPPLEMENTATION Start daily vaginal progesterone 200mg TARGETED INTERVENTION BUNDLE LOW-DOSE ASPIRIN Start LDA 81mg/day until 36 Weeks YES PreTRM® identifies those who may benefit most from targeted preterm birth interventions AS A RISK STRATIFICATION BIOMARKER TEST *PreTRM TESTING CRITERIA o Single Fetus o No History of Preterm Birth o Unknown or Normal Cervical Length o Intact Membranes o No Signs of Preterm Labor ©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.
Page 14
Clinical UtilityValidation 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 Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States. Randomized Controlled Trial PRIME TRIAL (2025) 5,018 patients 19 sites
Page 15
Neonatal outcomes after proteomic biomarker guided intervention: The AVERT PRETERM TRIAL S T U D Y D E S I G N 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 Care N=939 (mITT and ITT) Historical Controls N=10,000 Declined Treatment N=214 (ITT) The AVERT PRETERM Trial studied the health impacts of the PreTRM® test-and-treat strategy June 2018 — September 2020 ChristianaCare Hospital (Newark, DE) Black women comprised 26.5% of study participants, reflecting racial diversity as compared to the U.S. population The AVERT study characterized the benefits of the PreTRM test-and-treat strategy. mITT is used to assess whether the interventions themselves work when compliance 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 complied with the protocol or not.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, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States. Low Risk
Page 16
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. Diagnostics. 2024; 14(14):1462. https://doi.org/10.3390/diagnostics14141462 ©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. Reduction in neonatal hospital length of stay 7 Days Length of stay (days) Neonatal length of hospital stay (days) for babies with the longest hospital stays
Page 17
0-4 score given (4 = infant mortality) The score increases by 1 point for each additional diagnosis of: o Respiratory distress syndrome o Bronchopulmonary dysplasia o Intraventricular hemorrhage grade III or IV o All stages of necrotizing enterocolitis o Periventricular leukomalacia o Proven severe sepsis *Severe neonatal morbidity and mortality are defined as Neonatal Composite Morbidity & Mortality Index (NMI) ≥3 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) AVERT STUDY RESULTS Positive Impact on Neonatal Health Severe morbidity and mortality rates were significantly reduced 18% Reduction NMI Scores 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, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States. 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
Page 18
• 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. 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. *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 Intervention: The AVERT PRETERM Trial. Diagnostics. 2024; 14(14):1462. https://doi.org/10.3390/diagnostics14141462 ©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.
Page 19
Imaginary Mother A without PreTRM Imaginary 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 29 0/7 weeks o Necrotizing enterocolitis stage II/III o Respiratory distress syndrome1 40 days1 o Weekly nurse calls o Daily open label vaginal progesterone 200mg o Daily aspirin 81mg 31 0/7 weeks o Respiratory distress syndrome 12 days 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. https://doi.org/10.3390/diagnostics14141462 ©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. Risk of Singleton Spontaneous Preterm Birth o Perceived as low-risk o Normal cervical length o No history of preterm birth o Higher-risk result from the PreTRM Test AVERT OUTCOMES: o Increased gestational age at birth on average by 2.48 weeks for babies born before 32 weeks’ gestation)2 o 18% reduction in severe neonatal morbidity and mortality)2 o An average of 28-day reduction in neonatal hospital length of stay for babies born before 32 weeks gestation)2
Page 20
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 Prognostics, Inc. in the United States. PRIME STUDY In 2024, Sera completed a pivotal multicenter national trial: PRIME Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs (PRIME) Achievement of one or more primary endpoints resulted in the early termination of the study
Page 21
CONFIDENTIAL o Care management o Daily open label vaginal progesterone 200mg o Daily aspirin 81mg Control Arm N=2492 Full Analysis Set N=2390 Not-Higher Risk N=1918 Higher-Risk N=594 mITT Analysis N=1808 Treated with Interventions N=335 Screened Arm N=2526 The Randomized Controlled Trial Involved: 19 U.S. sites, including community practices and university-based or -associated medical centers From November 2020 – December 2023 Full Analysis Set N=564 mITT Analysis N=2325 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 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 gestation, after receiving a higher-risk test result in the prevention arm. Enrolled individuals who were subsequently diagnosed with COVID-19 and evaluated in a hospital setting during pregnancy were also excluded from mITT analyses. Enrolled and Randomized 1:1 N=5018 (ITT) Full Analysis Set N=1852 Full Analysis Set (FAS): - FAS constitutes all participants and their neonates with complete data through follow-up. - ITT constitutes the full analysis set with multiple imputation of missing outcomes. (n=5,018) mITT= modified intention-to-treat ©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. PRIME TRIAL Study design of the Prematurity Risk Assessment Combined with Clinical Interventions for Improving Neonatal Outcomes Reference: Iriye, B.K. et al. Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicen ter Randomized Controlled Trial. Presented at the Society for Maternal -Fetal Medicine Annual Pregnancy Meeting, Friday, January 31, 2025 (Abstract LB05).
Page 22
• 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) ©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. Reference: Iriye, B.K. et al. Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicenter Randomized C ontrolled Trial. Presented at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting, Friday, January 31, 2025 (Abstract LB05). PRIME Study Participants’ Characteristics
Page 23
1. Neonatal Composite Morbidity and Mortality Index (adapted from Hassan, 2011) Index Score Morbidity Criteria NICU Criteria 0 No morbidity No NICU admit 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: • Respiratory distress syndrome • Bronchopulmonary dysplasia • Grade 3 or 4 Intraventricular hemorrhage • Periventricular leukomalacia • Necrotizing enterocolitis • Culture proven sepsis 2. Neonatal length of stay (NNLOS)- as affected in the approximate 10% most affected quantile Measured in a modified intent to treat population • Underwent a second consent and accepted medications • Enrolled prior to 24 0/7 weeks and initiated treatment protocol • Did not have moderate or severe covid as defined by ACOG guidelines Co-Primary Outcomes ©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. Reference: Iriye, B.K. et al. Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicen ter Randomized Controlled Trial. Presented at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting, Friday, January 31, 2025 (Abstract LB05).
Page 24
Congest 10% of those accepting intervention (65%) All tested (with or without intervention) FAST added back 4.3% missing mITT (Primary Outcomes) FAS ITT NMI - 25% - 20% - 20% NNLOS - 18%* - 9% - 8% NICULOS N/A - 8% - 6% NICU admission N/A - 22% - 20% Endpoints Were Analyzed Across Three Study Populations/Datasets All participants accepting and initiating interventions, having primary outcomes, lacking severe COVID diagnosis. All tested participants with primary outcomes (those with & without intervention). FAS with outcomes added back (through imputation) for 4.3% with missing data. Results consistent across endpoints, except neonatal length of stay due to inclusion of all of the very short stays in FAS and ITT Endpoints Datasets *NNLOS co-primary outcome tested in the ~10% of longest stays ©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. Reference: Iriye, B.K. et al. Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicen ter Randomized Controlled Trial. Presented at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting, Friday, January 31, 2025 (Abstract LB05).
Page 25
TABLE 1 Modified intent-to-treat analysis of co-primary endpoints 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, neonatal hospital length of stay. *Controlled for parity, pre-enrollment aspirin use, and COVID-19 positivity. †Prespecified alpha reserved for final analysis was 0.0482 post-interim analysis. ‡Ordinal logistic regression analysis in entire mITT population; prevention versus control arm. An odds ratio <1 reflects lower NMI scores in the prevention arm. ¶Cox regression analysis in a prespecified quantile (~10%) of longest stays; control versus prevention arm. A hazard ratio <1 reflects shorter length of hospital stay in the prevention arm. P-values are below the Holm’s adjusted nominal p-values for trial success. ©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. PRIME TRIAL Excerpt from Abstract, The Pregnancy Journal: The Prematurity Risk Assessment Combined with Clinical Interventions for Improving Neonatal Outcomes Reference: Iriye, B.K. et al. Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicen ter Randomized Controlled Trial. Presented at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting, Friday, January 31, 2025 (Abstract LB05). 1. Neonatal Morbidity Index (NMI) • The Odds Ratio (OR) was 0.75 and significant. Thus, the odds of adverse outcomes on the NMI scale were 25% lower in the intervention group compared to the control group. 2. Neonatal Length of Hospital Stay: • The Hazard Ratio (HR) was 0.82 (95% CI: 0.69–0.99, p=0.044). • Hence, Infants in the intervention group had an 18% lower risk of prolonged hospital stays compared to the control group when focusing on the 10% with the longest stays. 3. Both outcomes met trial success criteria. mITT
Page 26
• The prevention arm demonstrated excellent outcomes in the full analysis set and intent-to-treat population of 5,018 participants. Substantial reductions were observed in neonatal morbidity, neonatal length of stay, NICU admissions, and NICU length of stay, highlighted by: • 20% reduction in odds of NMI (as seen in Adjusted Rate column of 0.80 NMI in the table 2) • 22% reduction in odds of NICU admissions (as seen in 0.78 Adjusted Rate column of NICU Admission in the table 2) • Total impact on NICU day reductions includes both NICU admissions and NICU length of stay. • Clinical trial findings show effectiveness of the screen-and-treat strategy and its potential to improve outcomes across diverse populations. Full Analysis Set of the Intent-to-Treat-Population* Variable Measure Adjusted Rate (95% CI)* P NMI‡ Odds ratio of increased NMI 0.80 (0.66-0.96) 0.015 NNLOS§ Ratio of average days in hospital 0.91 (0.88-0.94) <0.001 NICULOS¶ Ratio of average days in NICU 0.92 (0.88-0.97) 0.003 NICU Admission‡# Odds ratio of NICU admission 0.78 (0.65-0.93) 0.006 Intent-to-Treat Population with Multiple Imputation (N=5018) NMI‡ Odds ratio of increased NMI 0.80 (0.67-0.96) 0.019 NNLOS§ Ratio of average days in hospital 0.92 (0.98-0.95) <0.001 NICULOS¶ Ratio of average days in NICU 0.94 (0.89-0.99) 0.017 NICU Admission‡# Odds ratio of NICU admission 0.80 (0.67-0.96) 0.018 *Full analysis set is the intent-to-treat population minus 4.3% with missing data. †Prevention versus control; adjusted for parity, pre-enrollment aspirin use, and COVID-19 positivity. ‡Odds ratio; ordinal logistic regression (NMI); logistic regression (NICU admission). §Incidence rate ratio; Poisson regression. ¶Incidence rate ratio; zero-inflated Poisson regression. #Reductions in NICU admissions and NICULOS (time spent in the NICU) contribute independently to overall NICU day reductions across arms. Multiple imputation conducted using missing at random assumptions, which were similar to those obtained using missing not at random assumptions. TABLE 2 Neonatal outcomes in the intent-to-treat population ©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. Reference: Iriye, B.K. et al. Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicen ter Randomized Controlled Trial. Presented at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting, Friday, January 31, 2025 (Abstract LB05). FAS, ITT
Page 27
* Data were adjusted for covariates pre-enrolment aspirin usage, parity, and COVID-19 positivity. The full analysis set of the intention-to-treat population (n=4806) was used in all analyses except the GAB quantile analysis, which evaluated the earliest approximately 10% of births (n=497). ¶Hazard ratio; Cox proportional hazard regression analysis. The hazard ratio denotes the likelihood of delivering at a later gestational age in the prevention arm. P<0.001 for quantile result. #Odds ratio; logistic regression analysis. Rates of preterm birth showed a trend toward reduction, with the stronger effects observed at the earliest gestational age ©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. Reference: Iriye, B.K. et al. Neonatal Impact of Prematurity Risk Biomarker Screening with Targeted Interventions: A Multicen ter Randomized Controlled Trial. Presented at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting, Friday, January 31, 2025 (Abstract LB05). • Analysis of the earliest ~10% of births (Quantile) revealed a substantial extension of gestation (p<0.001) and a 78% increased likelihood of prolonged gestation (HR = 1.78). • Furthermore, as gestational age at birth decreased, the odds of preterm birth trended lower, becoming more pronounced at earlier gestational age, but did not reach statistical significance. • The PRIME Trial results showed no overall change in the mean gestational age at birth, which aligns with expectations. This is because treatments for preterm birth are not expected to extend further term births that comprise 90% of all births in the study. FAS
Page 28
Reference: 1. 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 Reference 2: 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). Details of meta-analysis methods: Inverse variance method, Restricted maximum-likelihood estimator for tau^2, Calculation of I^2 based on Q, Analysis of co-primary outcomes in each trial tested in the modified intent to treat population. Weights reflect the influence assigned to each study on the overall pooled estimate of effect size. Common effects assume all variations between datasets are fixed and cons tant. Random effects assume that variations across datasets are random and uncorrelated. 1 2 Co-Primary Outcome: Neonatal Hospital Length of Stay ©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. PRIME and AVERT TRIALS Evidence demonstrating the health impacts of the PreTRM Test: Neonatal length of hospital stay The two studies evaluating the clinical utility of the PreTRM® test shared the same two co-primary outcomes: 1. Neonatal morbidity and mortality 2. Neonatal length of hospital stay and same three-component intervention bundle: 1. Daily vaginal progesterone 2. Daily low-dose aspirin 3. Weekly telephonic nurse assessment An Aggregate Data Meta-Analysis of the AVERT Preterm1 historically controlled trial and the PRIME2 randomized controlled trial demonstrate that the two trial results, when combined, show significant improvement in neonatal length of hospital stay in the ~10% longest stays. Preliminary Aggregate Data Meta-Analysis of the PRIME and AVERT studies The pooled effect size from both studies corresponds to a 22% decreased risk of prolonged hospital stay mITT
Page 29
1 2 Co-Primary Outcome: Neonatal Morbidity and Mortality ©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. PRIME and AVERT TRIALS Evidence demonstrating the health impacts of the PreTRM Test: Neonatal morbidity and mortality Preliminary Aggregate Data Meta-Analysis of the PRIME and AVERT studies The two studies evaluating the clinical utility of the PreTRM® test shared the same two co-primary outcomes: 1. Neonatal morbidity and mortality 2. Neonatal length of hospital stay and same three-component intervention bundle: 1. Daily vaginal progesterone 2. Daily low-dose aspirin 3. Weekly telephonic nurse assessment An Aggregate Data Meta-Analysis of the AVERT Preterm1 historically controlled trial and the PRIME2 randomized controlled trial demonstrate that the two trial results, when combined, show significant improvement in neonatal morbidity and mortality. Reference: 1. 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 Reference 2: 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). Details of meta-analysis methods: Inverse variance method, Restricted maximum-likelihood estimator for tau^2, Calculation of I^2 based on Q, Analysis of co-primary outcomes in each trial tested in the modified intent to treat population. Weights reflect the influence a ssigned to each study on the overall pooled estimate of effect size. Pooled effect sizes. Common effects assume all variations between datase ts are fixed and constant. Random effects assume that variations across datasets are random and uncorrelated. The pooled effect size from both studies corresponds to a 22% decreased odds of NMI mITT
Page 30
Number Needed to Screen to prevent NICU admission and NICU days are critical metrics 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 clinical impact of a screening test Number Needed to Screen to prevent NICU admission: widely adopted tests vs PreTRM Transvaginal Ultrasound Cervical Length + Progesterone to prevent NICU Admission1 150 Demonstrated in PRIME and AVERT study3-4 References: 1. Am J Obstet Gynecol. 2016 February ; 214(2): 235–242. doi:10.1016/j.ajog.2015.09.102. 2.JAMA. 2021;326(6):531-538. doi:10.1001/jama.2021.11922. 3. Data on file 2: 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). ©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. o The lower the NNS the better o The NNS for established evidence-based tests recommended by the professional societies can be compared to PreTRM's screen-and-treat approach Number Needed to Screen for PreTRM to prevent 1 NICU day Sera PreTRM risk screening test + targeted interventions to prevent NICU Admission241 PRIME TRIAL FAS
Page 31
Annual economic value of PreTRM from a typical fee-for-service payer’s perspective ©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. Cost offsets=$53.75M Test costs=$29.79M Intervention costs=$9.19M Annual cost savings=$14.8M ($2.96 per covered life) 5M COVERED LIVES 39,773 pregnancies eligible for PreTRM and screened 13,920 'higher risk’ 7,656 accept interventions 10,750 NICU days reduced (NNS=3.7) 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 analysis of a large and diverse pregnancy cohort. medRxiv. 2021.09.08.21262940. + - =
Page 32
©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’m so grateful for the PreTRM Test!” Because after she took it, the results showed an extremely high risk for preterm labor. We worked together during the next 4 months and the outcome was a vaginal delivery, at term, with a healthy baby. My patient then told me… “I came home from the hospital with a healthy baby I can hold. My friend can only touch her baby in an incubator.” My patient then explained she’d just returned from a visit with a friend who was also pregnant—with a due date close to her own. The friend had a preterm delivery. She did not have the PreTRM test available to her and now both mom and baby were in the NICU. “I’m so glad we did the PreTRM Test.” Dr. Barbi Phelps-Sandall shares a patient pregnancy story “
Page 33
Next Milestones o Publications o Commercialization: Driving Next Inflection Point o Reimbursement o Guidelines o Regulatory o 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 United States.
Page 34
CONFIDENTIAL 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 Publications Awareness campaigns Early adopter cadre Institutional focus ACOG Bulletin 234 Engagement with SMFM leadership Development of PreTRM champions Review when evidence is sufficient for recommendation PRIME and AVERT publications Health Economics publication RWE study publication GRADE assessment of 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 United States.
Page 35
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 Pregnancy (CHAP) Study led to an update in ACOG guidance Study published in April 2022 in NEJM: demonstrated that utilizing a treatment threshold of 140/90 (vs. 160/105) for pregnant people with chronic hypertension provides improved outcomes ACOG recommended NIPT as an option to be “discussed and offered to all patients early in pregnancy, regardless of maternal age or baseline risk” in Oct ‘20 via practice bulletin with 87 references: o 1 Level I (Harmony/Roche RCT) o 23 Level II-2 o 27 Level II-3 o 27 Level III & 9 systemic revie/meta-analysis ACOG is conservative with their approach to recommending novel diagnostics ACOG recommended antenatal steroids in October 2017 with one pivotal study: SMFM presentation January 2016 by Cynthia Gyamfi- Bannerman, published in NEJM later that year1 There are examples of a pivotal RCT leading to a speedy ACOG practice advisory announcement...and then others that required more time & evidence to change guidelines. ©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. HERE ARE (3) CASE STUDIES Time to commercial inflection point influenced by guideline inclusion, can be supported by continued physician awareness building & community 1 2 3
Page 36
Cash, cash equivalents, and marketable securities on the balance sheet as of June 30, 2025 Source: Sera Q2 2025 10Q. SERA’S STRONG BALANCE SHEET Sera cash position extends through 2028 to support reaching seminal revenue inflection point $108.5M With ~$30M annual operating spend, strong balance sheet allows Sera to push full steam ahead on Commercialization to reach seminal inflection point
Page 37
Sera Leadership Zhenya Lindgardt President & CEO Former VP of Platform & Customer Engagement, Uber Technologies Former Senior Partner & Managing Director, The Boston Consulting Group Former CEO, The Commons Project Foundation MBA, Harvard University Former VP, Finance & Corporate Controller, Sera Former finance team member, Myriad Former auditor, Ernst & Young LLP Master of Accounting University of Utah; CPA Austin Aerts Chief Financial Officer Former National Precision Oncology General Manager, Commercial team Former VP, US Oncology & Customer Service Lee Anderson Chief Commercial Officer 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
Page 38
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 Sera Prognostics, Inc. in the United States.
Page 39
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 Prognostics, Inc. in the United States.