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.

纽约——Sera Prognostics公司周三表示，计划从今年开始支持多项研究，以加强其用于预测早产风险的血液检测的证据基础。

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.

它补充说，这些结果可以用来支持该测试的商业应用，以及纳入护理指南，并有可能提交给美国食品和药物管理局审批。

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.

塞拉公司周三还宣布，2024年第四季度收入同比下降41%，而其2024年全年收入较一年前下降了75%。

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.

在讨论其财务业绩的电话会议上，Sera Prognostics首席执行官Zhenya Lindgardt表示，最近的研究支持使用其PreTRM蛋白质组学测试。同时，该公司正与各机构合作，开始收集有关该测试在今年对孕妇和新生儿结果的影响及性能的“真实世界”证据。

Lindgardt noted that the company launched earlier this year a program to support investigator-led studies..

林加德指出，公司今年早些时候启动了一项支持研究者主导的研究的计划。

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.

该公司还计划与美国的公共卫生机构合作，衡量和证明检测的影响，尤其是在早产率高于平均水平的州。

Company officials

公司官员

said earlier this year

今年早些时候说的

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..

其包含 5,018 名患者的 PRIME（早产风险评估结合临床干预以改善新生儿结局）试验的初步结果显示，该测试有助于改善孕妇和新生儿的结局。Sera 当时表示，对同意接受治疗的孕妇使用该测试后，健康并发症减少了 25%，新生儿住院时间减少了 18%。

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.

虽然该公司尚未公布全部结果，但林德加特表示，研究表明，使用该测试使得新生儿重症监护病房的入院率总体降低了 20%。

'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.'

“新生儿重症监护室（NICU）入院人数的显著减少非常重要，因为这是支付方在降低其参保患者医疗成本方面的重点关注之一。”她说道，“NICU入院人数的减少表明，通过我们的检测与治疗策略，我们成功地使五分之一的婴儿免于进入NICU。”

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..

PreTRM是一种基于质谱分析的血液检测方法，用于测定胰岛素样生长因子结合蛋白4（IGFBP4）与性激素结合球蛋白（SHBG）的比值。该检测用于在妊娠18至20周期间识别哪些孕妇存在早产及相关并发症的风险。

The PRIME trial was conducted at 19 US sites from November 2020 through December 2023, when the company

PRIME 试验于 2020 年 11 月至 2023 年 12 月在美国的 19 个地点进行，当时该公司

announced

宣布

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.

数据安全监测委员会建议尽早结束注册，因为研究人员记录了强劲的中期结果。林加德特表示，Sera 一直在与研究调查人员合作，争取在同行评审的期刊上发表完整的 PRIME 研究结果，并希望发表能在未来几个月内实现。

Meanwhile, the investigators have been discussing upward of a dozen additional publications that could incorporate PRIME data, she said..

她说，同时，调查人员一直在讨论可能包含PRIME数据的十几种其他出版物。

'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.

林德加特说：“我们认为，从PRIME数据集中能够获得的价值越多，在新发表的文章中，关于PreTRM检测的测试与治疗策略的价值的证据就会越多。”

Earnings results

收益结果

The company also reported after the close of the market on Wednesday that its Q4 revenues fell 41 percent year over year.

该公司还在周三股市收盘后报告称，其第四季度收入同比下降了41%。

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.

截至2024年12月31日的季度，这家位于盐湖城的公司报告收入为24,000美元，而前一年同期收入为41,000美元。

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..

公司表示，其销售、一般和管理（SG&A）费用在本季度从一年前的500万美元增长了26%，达到630万美元，这主要是由于增加了旨在推动未来季度增长的商业活动支出。同时，公司的研发（R&D）费用下降了20%，从390万美元降至310万美元。

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.

该公司记录了2024年第四季度净亏损860万美元，即每股0.25美元，而2023年第四季度的净亏损为790万美元，即每股0.25美元。

For full-year 2024, Sera reported that its revenues fell 75 percent to $77,000 from $306,000 in FY 2023.

Sera 报告称，2024 全年收入从 2023 财年的 30.6 万美元下降了 75%，至 7.7 万美元。

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.

公司 SG&A 支出从 2,470 万美元下降了 11%，至 2,190 万美元，而研发支出在 2023 财年从 1,520 万美元下降了 3%，至 1,470 万美元。

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.

塞拉CFO奥斯汀·艾尔茨在电话中表示，2025年是推动关键利益相关者参与和采用该测试的关键一年，而运营费用的增加是由商业化投资推动的。

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..

在给投资者的报告中，TD Cowen 分析师丹·布伦南写道，一个有效的早产风险测试将受到医生、患者和支付方的欢迎。假设 PreTRM 在2028年被纳入指南，并且 Sera 通过 Medicaid 获得该测试的报销，公司预计收入将从2025年的50万美元增长到2030年的4700万美元，并且很可能继续保持强劲增长。

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.

公司这一年录得净亏损 3290 万美元，即每股亏损 0.99 美元，而上一年的亏损为 3620 万美元，即每股亏损 1.16 美元。

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.

公司年底持有 400 万美元的现金及现金等价物、4220 万美元的可出售证券以及 2200 万美元的长期可出售证券。

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..

该公司还表示，其在 2025 年 2 月通过公开发售筹集了 5750 万美元，这使得公司的现金储备可以延长至 2028 年。公司称，将利用这笔资金扩大其用于预测孕妇早产风险的 PreTRM 蛋白质组学血液测试的商业化，加快公司在欧盟的扩张，并资助支持该测试更广泛采用的研究。

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公司表示，这些研究的结果还可以用于支持向FDA提交PreTRM测试的审批申请。

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..

Sera单独宣布，Jeff Elliott将加入其董事会，自3月20日起生效。他是波士顿咨询集团的高级顾问，同时也是Quanterix董事会的成员。他曾担任Exact Sciences的首席财务官和首席运营官。该公司表示，Ryan Trimble和Marcus Wilson都将于6月退出董事会。