NEW YORK – Sera Prognostics said Wednesday that the firm aims to publish by the spring of 2025 study results that will bolster the case for the use of its PreTRM proteomic test to predict the risk of preterm birth and guide the treatment of patients whose results show that they are at elevated risk for the condition.
The Salt Lake City-based firm aims to have results from its PRIME (Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes) research on hand in time for key conferences being held by pregnancy and maternal health groups. The firm published last month the results of its AVERT PRETERM trial that examined the use of the PreTRM test to identify patients as high risk for preterm birth and to guide treatment with vaginal progesterone and aspirin along with increased monitoring.
Sera President and CEO Zhenya Lindgardt said in a statement that the studies are "necessary prerequisites for growing our evidence portfolio, adoption, and building revenue over time."
"To further expand awareness of the benefit of our PreTRM offering we are pursuing cost-effective multichannel strategies with focused investments where we anticipate the best impact for value delivered and, at the same time, working to support the establishment of care guidelines leveraging our compelling test-and-treat data," she said.
Lindgardt said during a conference call Wednesday following the company's Q2 earnings that the firm demonstrated during the AVERT PRETERM trial that its test-and-treat strategy was associated with an 18 percent reduction in severe neonatal morbidity and mortality. It also reduced neonatal hospital stays by an average of seven days, with further reductions for babies born before 32 weeks, she added.
Lindgardt said that payors have been excited to see that the trial suggests that screening pregnant expectant mothers with the PreTRM test can reduce overall NICU usage.
The firm also announced in December that it was following a recommendation of the PRIME study's data safety monitoring board to end study enrollment early due to strong interim results for efficacy. In Q2 2024, the firm submitted to a journal a manuscript about the interim results, Lindgardt said, noting that the company plans to submit separate manuscripts for other datasets.
"With our solid AVERT results being published and the PRIME results pending, we're actively engaging with guidelines-setting bodies to help them develop care guidelines that leverage our study findings for improved pregnancy outcomes," she said.
Lindgart said that any guidelines that incorporate Sera's research and tests should support payor coverage as well as demand from patients and physicians.
Lindgart also noted that New York state issued in July conditional approval for use of the PreTRM test with Sera's updated whole-blood collection kits. The kits reduce the cost of goods per test and improve lab efficiency, and the approval in New York will allow the company to move forward with a national rollout of the tests using the updated methods, she said.
Meanwhile, Sera continues development of its pipeline of proteomic tests. The company was not ready to provide in-depth information on those upcoming products, but it was preparing to share data on its consumer-directed ELISA-based time-to-birth test that is designed to provide pregnant individuals with an estimated due date.
The company said this spring that it was also developing other proteomic tests that would be used to identify potential complications in pregnant patients. One is a prognostic assay that would be used to predict the likelihood of patient outcomes such as the need for an early cesarean delivery and another is a panel for the stratification of patients by the risk of unfavorable outcomes.
The firm anticipates that PreTRM will provide the bulk of revenues over the next several years although the other products are expected to provide meaningful contributions, Lindgart said.
Sera also said after the close of the market on Wednesday that the firm's second quarter revenues fell 80 percent to $24,000 compared to $123,000 in the year-ago period.
For the quarter ended June 30, the firm's R&D spending increased about 19 percent to $4.4 million from $3.7 million in the prior-year quarter due to new product development costs. SG&A expenses, however, declined 37 percent to $4.9 million from $7.8 million a year earlier as the company streamlined commercial operations and developed a more focused commercial strategy, among other changes to reduce operating expenses.
Sera CFO Austin Aerts said during Wednesday's call that the firm had rightsized its cost structure during 2023 and has focused since on building the foundation of evidence for its PreTRM test, among other preparations for the firm's anticipated commercial expansion starting in 2025.
Lindgardt said that those preparations have included expanding the company's operations for account and revenue cycle management as well as adding medical science liaisons.
Sera reported a net loss of $8.3 million, or $.25 per share, for the recently completed quarter compared to a net loss of $10.5 million, or a $.34 per share, in Q2 2023.
The firm ended the quarter with $4.7 million in cash and cash equivalents, $46.3 million in marketable securities, and $30.0 million in long-term marketable securities. The firm has sufficient cash for operations "well into" 2027, Aerts said.
In morning trading on Thursday on the Nasdaq, shares of Sera were down about 2 percent at $7.24.