NEW YORK – Sera Prognostics said after the close of the market on Wednesday that its third quarter revenues were down 31 percent to $29,000 from $42,000 in the year-ago quarter.
In the quarter ended Sept. 30, the company reported that its SG&A expenses rose 17 percent to $5.4 million from $4.6 million a year earlier while its R&D spending was flat year over year at $3.5 million.
Sera reported a net loss of $7.9 million, or $.24 per share, in Q3 2024 compared to a net loss of $7.2 million, or $.23 per share, a year earlier.
The company ended the quarter with $2.7 million in cash and cash equivalents, $47.1 million in marketable securities, and $24.6 million in long-term marketable securities.
Sera noted that on Oct. 1 it began offering through its website at-home sample collection for its proteomic test called PreTRM blood-based that is used to identify during weeks 18 to 20 of a pregnancy which patients are at-risk of preterm birth and related complications. Sera previously announced plans to ramp up sales of the test in 2025. The firm said on Wednesday that it has been hiring sales and marketing personnel to drive test adoption and revenues.
Additionally, the Salt Lake City-based company also is aiming to publish in early 2025 the results of a study on the use of the test to reduce adverse pregnancy outcomes. Sera said that data analysis is underway for the Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes (PRIME) study and it plans to make results available in connection with key pregnancy and maternal health conferences as well as submit a manuscript to a peer-reviewed journal.
"We are successfully putting in place the key prerequisites for commercial success in anticipation of our full PRIME study results achieving publication and further illustrating the benefits of our PreTRM capabilities and test-and-treat strategy," Sera Prognostics President and CEO Zhenya Lindgardt said in a statement.
The company said in August with the release of Q2 results that it plans to publish in spring of 2025 study data that will support the use of PreTRM, and company officials noted at the time that results from the Sera-funded AVERT PRETERM trial had demonstrated that their testing strategy was associated with an 18 percent reduction in severe neonatal morbidity and mortality. The firm also reported in December that it was following the recommendation of the data safety monitoring board for the PRIME study to end enrollment early due to strong interim results.
During the Q2 conference call, company officials also said that New York state had issued conditional approval in July for the use of PreTRM with Sera's updated whole-blood collection kits and the approval in New York will help the company with its national rollout of the tests. While the US Food and Drug Administration has said that it was phasing in requirements for premarket review of new LDTs, it also has said that it will allow LDTs to come to market with approval through the New York State Department of Health's Clinical Laboratory Evaluation Program.
In morning trading on Thursday on the Nasdaq, shares of Sera were down 3 percent at $8.48.