NEW YORK – Sera Prognostics plans to support multiple studies starting this year to reinforce the evidence base for its blood test for the risk of preterm birth, the company said on Wednesday.
It added that the results could be used to support commercial adoption of the test as well as inclusion in care guidelines and a potential submission for US Food and Drug Administration approval.
Sera also announced on Wednesday that for the fourth quarter of 2024, its revenues declined 41 percent year over year, while its full-year 2024 revenues were down 75 percent compared to a year ago.
On a conference call to discuss its financial results, Sera Prognostics CEO Zhenya Lindgardt said that recent studies support use of its PreTRM proteomic test. Meanwhile, the company is partnering with institutions to begin gathering this year "real-world" evidence on the test's performance and impact on outcomes for pregnant patients and newborns. Lindgardt noted that the company launched earlier this year a program to support investigator-led studies.
The firm also plans to partner with public health agencies in the US to measure and demonstrate the impact of testing, especially in states with higher-than-average rates of preterm births.
Company officials said earlier this year that preliminary results from its 5,018-patient PRIME (Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes) trial showed that the test could help to improve outcomes for pregnant women and newborns. Sera said at the time that use of the test in pregnant women who consented to accept treatment led to a 25 percent reduction in health complications and an 18 percent reduction in the length of hospital stays for newborns.
While the firm has yet to publish the full results, Lindgardt said that the study demonstrates that use of the test led to a 20 percent overall reduction in NICU admissions.
"This significant reduction in NICU admissions is very important as this is a top focus for payors in reducing healthcare costs for their insured patients," she said. "The NICU admission reduction showed that we are keeping one out of five babies out of the NICU with our test-and-treat strategy."
The PreTRM is a mass spectrometry-based blood test that is used to determine the ratio of insulin-like growth factor binding protein 4 (IGFBP4) to sex hormone binding globulin (SHBG). The test is used to identify during weeks 18 to 20 of a pregnancy which patients are at-risk of preterm birth and related complications.
The PRIME trial was conducted at 19 US sites from November 2020 through December 2023, when the company announced that the data safety monitoring board overseeing the study recommended an early end to enrollment as the researchers recorded strong interim results. Lindgardt said that Sera has been working with the study investigators toward publication of the full PRIME study results in a peer-reviewed journal, and she hopes that publication will occur in the coming months. Meanwhile, the investigators have been discussing upward of a dozen additional publications that could incorporate PRIME data, she said.
"We think that the more value [that] can be derived from PRIME data set in new publications, the more evidence there will be in the market about the value of the test-and-treat strategy of the PreTRM test," Lindgardt said.
Earnings results
The company also reported after the close of the market on Wednesday that its Q4 revenues fell 41 percent year over year.
For the quarter ended Dec. 31, 2024, the Salt Lake City-based firm reported revenues of $24,000 compared to revenues of $41,000 a year earlier.
The company said that its SG&A expenses rose 26 percent to $6.3 million for the quarter from $5.0 million a year ago, mostly due to increased spending on commercial activities that were intended to drive growth in future quarters. Meanwhile, the company's R&D expenses fell 20 percent to $3.1 million from $3.9 million.
The firm recorded a net loss in Q4 2024 of $8.6 million, or $.25 per share, compared to a net loss of $7.9 million, or $.25 per share, in Q4 2023.
For full-year 2024, Sera reported that its revenues fell 75 percent to $77,000 from $306,000 in FY 2023.
The firm's SG&A spending fell 11 percent to $21.9 million for the year from $24.7 million, whereas R&D spending fell 3 percent to $14.7 million from $15.2 million in FY 2023.
Sera CFO Austin Aerts said during the call that 2025 is a pivotal year to drive engagement and adoption of the test among key stakeholders, and the rise in operating expenses is driven by investments into commercialization.
In a note to investors, TD Cowen analyst Dan Brennan wrote that an effective test for the risk of preterm birth would be welcomed by doctors, patients, and payors. Assuming PreTRM is included in guidelines in 2028 and Sera secures reimbursement for the test through Medicaid, the company predicts revenues will ramp up from $500,000 in 2025 to $47 million in 2030, with strong growth likely to continue.
For the year, the company recorded a net loss of $32.9 million, or $.99 per share, compared to a loss of $36.2 million, or $1.16 per share, a year earlier.
The company ended the year with $4.0 million in cash and cash equivalents, $42.2 million in marketable securities, and $22.0 million in long-term marketable securities.
The firm also said that it raised $57.5 million through a public offering in February 2025, which extended the company's cash runway through 2028. The firm said that it will use the proceeds to expand the commercialization of its PreTRM proteomic blood test that is used to predict a pregnant patient's risk of preterm birth, hasten the company's expansion into the EU, and fund studies to support increased adoption of the test.
The results of those studies could also be used to support a submission to the FDA for approval of the PreTRM test, Sera said.
Sera separately announced that Jeff Elliott was joining its board of directors, effective March 20. He is a senior adviser at Boston Consulting Group and a member of Quanterix's board of directors. He previously served as the CFO and chief operating officer for Exact Sciences. The firm said that Ryan Trimble and Marcus Wilson are both stepping down from the board in June.