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Sera Prognostics Expects Boost to Revenues From Promising Study Results


NEW YORK – Sera Prognostics said Wednesday that the firm expects in 2024 to publish encouraging study results that show the benefits of using its prognostic test for the risk of preterm birth, leading to increased revenues from that test as early as 2025.

The Salt Lake City-based firm reported Dec. 6 that the data safety monitoring board that was overseeing the PRIME study of the firm's PreTRM proteomic blood tests had recommended an early halt to enrollment due to strong interim results related to the test's efficacy. Sera CEO Zhenya Lindgardt said in a conference call on Wednesday to discuss the company's fourth quarter and full-year 2023 financial results that the firm is withholding details from the PRIME study ahead of its publication. However, she added the firm hopes to report breakthrough results that support the findings from two previous studies that indicate the use of PreTRM test results in treatment decisions can improve patient management and outcomes.

"These results are anticipated to show that using the PreTRM test and acting on the information it provides can lead to reductions of severe neonatal morbidity and mortality, NICU length of stay, and the number of babies born prematurely," Lindgardt said.

Lindgardt said that the firm has focused its commercial strategy this year on publishing the evidence to support the use of its test to improve patient outcomes, inking contracts with payors, and raising awareness of the test and the study results among healthcare providers and the public. The firm also has been meeting with entities that establish clinical guidelines, she said.

In addition to publication of the interim PRIME study results, Sera is working with its principal investigators to prepare additional manuscripts for publication on findings related to interventions that were tested in the study, the cost-effectiveness of using the results to inform treatment, and further results once the study is completed.

"We're targeting PRIME publication in the second half of the year, and only with that publication in hand as a prerequisite can we expect payors to initiate policy coverage reviews," she said. "These reviews are expected to be multimonth or longer processes."

By building that foundation for reimbursement in 2024, she said that the firm expects increased revenues from the test as early as 2025.

Lindgardt said that the company also has made progress toward implementing simple and inexpensive sample collection methods into its assay and efficient methods for laboratory processing that will help to increase availability of the test including among underserved patients who lack access to hospital-based obstetric care. In the coming months, the firm plans to launch in some regions a device for the self-collection of dried capillary blood samples for use with the PreTRM test.

She added that the firm also has three more proteomic tests that are in the late stages of development, including a consumer-directed ELISA-based time-to-birth test to estimate a patient's due date. The test will use patient-collected capillary blood samples that will be sent to a partner laboratory for analysis. Also, the firm is developing a prognostic assay that would be used with a proprietary algorithm to predict the likelihood of patient outcomes such as above-average weight gain or the need for an early cesarean delivery, and a panel for the stratification of pregnant patients by the risks of unfavorable outcomes.

The company also reported after the close of the market on Wednesday that its revenues declined 37 percent in Q4 2023 to $41,000 compared to $65,000 a year earlier.

Sera reduced its net loss for the quarter ended Dec. 31 to $7.9 million, or $.25 per share, compared to a net loss of $9.7 million, or $.31 per share, in the year-ago quarter.

While the company increased its R&D spending 11 percent to $3.9 million during the quarter compared to $3.5 million a year earlier, the firm cut its SG&A costs by 28 percent year over year to $5.0 million from $6.9 million. Most of the savings came from streamlining commercial operations, Sera said.

The firm's full-year revenues were up 14 percent to $306,000 compared to $268,000 for 2022.

For the full fiscal-year 2023, Sera reported that it had cut its net losses to $36.2 million, or $1.16 per share, compared to $44.2 million, or $1.43 per share, in 2022. The firm cut its SG&A spending 22 percent during the year to $24.7 million from $31.5 million a year earlier, while its R&D spending was up 7 percent to $15.2 million from $14.2 million.

The company ended 2023 with $79.9 million in cash and cash equivalents, and $45.2 million in marketable securities. Sera CFO Austin Aerts said on Wednesday's call that the firm has sufficient cash to fund its operating expenses into 2027.