Publication Of Health Economic Analysis

Publication illustrates clinical benefit of combining PreTRM^® testing with evidence-based interventions to improve neonatal health and reduce total health costs

Positive impact on preterm births, neonatal intensive care admissions, overall hospital length of stay and a net $54 million reduction in total costs in the analyzed population

Salt Lake City – September 14, 2021 – Sera Inc., The Pregnancy Company™, focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the publication of a rigorous clinical and economic analysis using actual claims data from a broad population of Anthem affiliated health plans to assess the potential value of the PreTRM^® test-and-treat strategy.

The study conservatively modeled the PreTRM^® strategy, consisting of testing and proactive evidence-based interventions, within Anthem claims data from individual and employer-sponsored plans, and showed both improved neonatal outcomes and reduced immediate and long-term treatment costs associated with premature birth, when compared to routine care. These results were published in the peer-reviewed journal ClinicoEconomics and Outcomes Research in an article entitled “Cost-Effectiveness of a Proteomic Test for Preterm Birth Prediction.”

“The publication of these data adds to the growing body of evidence supporting the effectiveness of Sera’s test-and-treat strategy in identifying women at risk for sPTB and enabling evidence-based interventions to reduce risk, thus improving pregnancy outcomes while reducing the economic burden on payers and health care systems,” stated Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera. “We look forward to discussing the implications of these data as we engage with employers and payors in our efforts to improve pregnancy outcomes and reduce healthcare costs through expanded access to the PreTRM^® test.”

The study analysis was conducted by Sera in partnership with HealthCore, using claims data of more than 40,000 pregnant women and infants who were members of individual and employer-sponsored Anthem health plans. The analysis evaluated the PreTRM^® test-and-treat strategy by modeling the application of the PreTRM^® test during weeks 19 or 20 of pregnancy, and assessed the benefit of proactive interventions consisting of more intensive case-management and monitoring, as well as pharmacologic interventions for women identified as higher-risk by the test, whereas usual care was assumed for any women without higher PreTRM^® risk.

Key findings of the analysis include:

20% reduction in preterm birth <37 weeks’ gestation
33% reduction in births <32 weeks’ gestation
10% reduction in neonatal intensive care admissions
7% reduction in overall hospital length-of-stay
$863 net savings ($1,608 gross savings) per pregnant woman, a $54 million reduction in total costs over the study population

“The PreTRM^® test-and-treat strategy is associated with both improved outcomes and lower total costs, which is rare among modern medical interventions, said Michael Grabner, Principal Scientist for HealthCore. “The findings were consistent across a wide variety of possible scenarios in terms of test uptake, treatment adherence, treatment efficacy, and accrued costs.”

Based on the study’s estimated net cost savings to the healthcare system of $863 saved per pregnant woman, the authors estimate that more than $850 million could be saved annually in U.S. individual and employer-sponsored health plans, assuming full uptake of the test-and-treat strategy. This is based on an assumption of approximately 4 million births per year, of which approximately 50% occur in women with such commercial health insurance, and further assuming at least half have no evident risk factors for preterm birth.

About Sera, Inc.

Sera is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera’s mission is to deliver early, pivotal information in pregnancy to physicians, enabling them to improve the health of their patients, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera’s precision medicine PreTRM^® test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera is located in Salt Lake City, Utah.

About Preterm Birth

Preterm birth is defined as any birth before 37 weeks’ gestation and is the leading cause of illness and death in newborns. The 2020 March of Dimes Report Card shows that of approximately 3.8 million babies born annually in the United States, more than one in ten is born prematurely. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016.

About the PreTRM^® Test

The PreTRM^® test is the only broadly clinically validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM^® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM^® test permits physicians to identify, during the 19th or 20th week of pregnancy, which women are at increased risk for preterm birth, enabling more informed, personalized clinical decisions based on each woman’s individual risk. The PreTRM^® test is ordered by a medical professional.

Sera, the Sera logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera, Inc in the U.S. and/or other countries.

Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to engaging with employers and payors to potentially expand access to the PreTRM^® test; estimates of more than $850 million to be saved annually assuming full uptake of the risk-screen-and-treat strategy; and the company’s strategic directives under the caption “About Sera, Inc.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; the ongoing COVID-19 pandemic and its impact on our operations, as well as the business or operations of third parties with whom we conduct business; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading “Risk Factors” contained in our Final Prospectus on Form S-1, which was filed with the Securities and Exchange Commission on July 14, 2021, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

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