SALT LAKE CITY - Sera Prognostics Inc. (NASDAQ: NASDAQ:SERA), a company specializing in pregnancy biomarker information, has announced the publication of results from its AVERT PRETERM TRIAL in the journal Diagnostics. The trial, conducted at ChristianaCare in Wilmington, Delaware, assessed the effectiveness of the PreTRM® test-and-treat strategy in improving neonatal health outcomes.
The study's findings indicated a statistically significant 18% reduction in severe neonatal morbidity and mortality. Moreover, there was a notable 7-day reduction in the mean neonatal hospital length of stay. For infants born before 32 weeks' gestation, the reduction in neonatal hospital stay extended to 28 days.
Overall, the test-and-treat approach was associated with a decreased odds of preterm birth and spontaneous preterm birth at various gestational ages, as well as an average NICU length of stay savings of 0.6 days per pregnancy.
Dr. Matthew Hoffman, the study's principal investigator, stated that the results suggest biomarker-based stratification and preventive interventions could mitigate preterm birth complications, even in pregnancies historically considered low risk.
Zhenya Lindgardt, President and CEO of Sera Prognostics, emphasized the significance of the findings for improving the health of babies in asymptomatic pregnant mothers without typical risk factors.
The AVERT PRETERM TRIAL compared outcomes from an active arm of approximately 1,463 expectant mothers who were screened and treated based on the PreTRM® Test results, with a historical control arm of around 10,000 patients. The study focused on important neonatal outcomes such as total neonatal length of hospital stay and composite neonatal morbidity/mortality.
Sera Prognostics also provided an update on its PRIME study. In December 2023, the Data Safety and Monitoring Board recommended halting enrollment due to efficacy, with co-primary endpoints meeting the stopping criteria for statistical significance. As of May 2024, deliveries for the remaining 2,200 participants had been completed, and data gathering for the final PRIME results is underway.
The PreTRM® Test, offered by Sera Prognostics, is a blood-based biomarker test that predicts the individualized risk of spontaneous premature delivery, allowing for earlier interventions in higher-risk pregnancies. This announcement is based on a press release statement from Sera Prognostics, Inc.
In other recent news, Sera Prognostics, a company specializing in pregnancy biomarker information, has been confirmed for inclusion in the Russell Small-Cap 2000 and Russell 3000 indexes.
This significant development is part of the annual reconstitution of the Russell indexes, which ranks the 4,000 largest US stocks by market capitalization. The inclusion is seen as a progressive step in a year expected to be filled with milestones aimed at enhancing maternal and neonatal healthcare.
On the earnings front, Sera Prognostics reported a decrease in operating expenses and net loss for the first quarter of 2024. The company's Q1 2024 operating expenses were down 20% year-over-year, with a net loss reduction of 24%. The company had $85.4 million in cash and equivalents as of March 31, 2024.
The company is also focusing on growth, enhancing its product offerings, and expanding its commercial operations. It is preparing for the release of new data and products while managing cash effectively.
Notably, the company is actively engaging with stakeholders to promote the adoption of its PreTRM Test and is preparing for the launch of its Time to Birth product with data to be released soon. These are the recent developments in Sera Prognostics.
InvestingPro Insights
As Sera Prognostics Inc. (NASDAQ: SERA) continues to make strides in the field of pregnancy biomarker information with their recent study results, their financial health and market performance provide additional layers of insight.
According to InvestingPro data, Sera Prognostics holds a market capitalization of 175.68 million USD. Despite the positive clinical outcomes, the company's revenue for the last twelve months as of Q1 2024 was reported at 0.21 million USD, reflecting a decline of 37.58% in revenue growth. This contraction in revenue may raise concerns about the company's ability to scale its operations and market reach.
InvestingPro Tips suggest the stock is currently in oversold territory, which could indicate a potential rebound or a buying opportunity for investors. Furthermore, while the company has managed a high return over the last year with a 65.03% price total return, analysts do not anticipate Sera Prognostics will be profitable this year. This lack of immediate profitability could be a critical consideration for investors looking at the long-term viability of the company.
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