SERA PROGNOSTICS REPORTS FOURTH QUARTER 2024 FINANCIAL RESULTS

Rhea-AI Summary

Sera Prognostics (NASDAQ: SERA) announced its Q4 and full-year 2024 financial results, highlighting significant clinical achievements and financial developments. The company's PRIME study demonstrated promising results, showing a 25% reduction in neonatal morbidity and mortality index and an 18% reduction in neonatal hospital stay.

Financial highlights include: Q4 2024 revenue of $24,000 (down from $41,000 in Q4 2023), with operating expenses of $9.4 million (up 6% YoY). Full-year 2024 revenue was $77,000 (down from $306,000 in 2023), while net loss improved to $32.9 million (from $36.2 million in 2023).

The company successfully raised $57.5 million through a public offering in February 2025, extending its cash runway through 2028. As of December 31, 2024, Sera held $68.2 million in cash and equivalents. The funds will support US commercial expansion, European market preparation, and additional studies for their PreTRM test.

Insights

Financial Analyst

Sera Prognostics' Q4 2024 results reveal a company at a pivotal inflection point. While revenues remain minimal at just $24,000 (down from $41,000 in Q4 2023), the recent $57.5 million capital raise significantly bolsters their financial position, extending runway through 2028. This fundraising success demonstrates strong investor confidence following the positive PRIME study results.

The company's financial metrics show careful resource management with annual operating expenses decreasing to $36.7 million from $40.1 million, while annual net loss improved to $32.9 million from $36.2 million. However, Q4 saw a strategic increase in SG&A to $6.3 million (up from $5.0 million) as the company positions for commercialization.

With approximately $125.7 million in cash post-offering, Sera now has sufficient capital to execute its commercialization strategy. The parallel decrease in R&D expenses ($3.1 million, down 19%) signals a shift from clinical validation to market execution. The company's planned commercial expansion in targeted US regions and preparation for EU market entry represents a critical transition from research-focused to revenue-generating operations, though meaningful revenue growth will take time.

Healthcare Specialist

The PRIME study results represent a significant clinical validation for Sera's PreTRM test. The 25% reduction in neonatal morbidity and mortality index (NMI) and 18% reduction in hospital stay length are clinically meaningful outcomes that address core healthcare challenges in pregnancy management. Particularly impressive is the 22% reduction in NICU admissions in the broader population, which has substantial implications for both patient outcomes and healthcare economics.

The presentation of these results at the Society for Maternal Fetal Medicine (SMFM) conference - the premier global forum for pregnancy medicine - provides important scientific credibility. Having Dr. Brian Iriye, a respected maternal-fetal medicine expert, as principal investigator further strengthens the study's standing.

Sera's test addresses a significant unmet need in prenatal care where traditional screening methods have limitations. The company's planned commercial strategy of partnering with selected payers and providers is strategically sound - this approach can create focused proof points before broader expansion. The potential EU market preparation indicates recognition of the global applicability of their technology. The planned additional studies and potential FDA submission pathway demonstrate a comprehensive regulatory strategy that could significantly accelerate adoption if successful.

SALT LAKE CITY, March 19, 2025 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company^® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the fourth quarter and full year ended December 31, 2024.

Recent Highlights:

• On January 6, 2025, the Society for Maternal Fetal Medicine ("SMFM") published an abstract reporting topline results for Sera's Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs ("PRIME") study.
• Results of the PRIME study were also accepted as a late-breaking abstract for oral podium presentation at the SMFM 2025 Pregnancy Meeting™ on January 31, 2025, widely considered the world's leading conference on the subject of pregnancy. During this event, Dr. Brian Iriye – maternal-fetal medicine expert at the High Risk Pregnancy Center in Las Vegas, Nevada, and principal investigator for the PRIME study – presented the results of the full PRIME study. Among other notable results, the study showed that both primary outcomes met success criteria, showing a 25% reduction in neonatal morbidity and mortality index (NMI) and an 18% reduction in neonatal length of hospital stay among the pre-specified modified intent-to-treat population. Further, the study showed a 20% reduction in NMI and 22% reduction in NICU admissions among a broader intent-to-treat population.
• The Company also hosted a virtual R&D day in conjunction with the SMFM Pregnancy Meeting further showcasing results of the PRIME study. During these events, Dr. Iriye shared a presentation illustrating several key findings about the performance of Sera's PreTRM^® test-and-treat strategy.
• The Company raised $57.5 million through a public follow-on offering in February 2025, further extending the Company's cash runway through 2028.
• Leveraging proceeds from this fundraise, Sera will begin expanding its commercial efforts in selected geographies in the United States, partnering with selected payers and providers to drive adoption of its PreTRM test; accelerating preparations for expansion in the European Union; and funding additional studies designed to further increase adoption, including a potential submission to the U.S. FDA seeking broad approval of the PreTRM test.

"We are pleased with our progress during the year and, more recently, with the results of our full PRIME study," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "We are also thankful to our investors for supporting our fundraise last month, which we believe will promote our mission to mitigate the societal and healthcare costs of spontaneous premature birth and afford better outcomes for moms and babies by helping us drive adoption of our technology."

Fourth Quarter 2024 Financial Results

Fourth quarter 2024 revenue was $24,000 compared to $41,000 for the same period of 2023.

Total operating expenses were $9.4 million, up 6% from $8.9 million for the fourth quarter of 2023 as Sera continued to manage operating expenses while making select investments in product development and commercialization activities to expand future sales generation.

Research and development expenses for the fourth quarter of 2024 were $3.1 million, and down approximately 19% compared with the fourth quarter of 2023.

Selling, general and administrative expenses for the fourth quarter of 2024 were $6.3 million, up from $5.0 million for the fourth quarter of 2023 due primarily to the Company focused spending on commercial activities anticipated to drive growth in future quarters.

Net loss for the quarter was $8.6 million compared to $7.9 million for the prior-year quarter.

Full Year 2024 Financial Results

Total full year 2024 revenue was $77,000 compared to $306,000 for full year 2023.

Total operating expenses were $36.7 million, down from $40.1 million for 2023.

Research and development expenses for 2024 were $14.7 million and down from $15.2 million for the prior year due primarily to lower clinical study costs.

Selling, general and administrative expenses for 2024 were $21.9 million, down significantly from $24.7 million for 2023 due primarily to steps previously taken to streamline commercial operations and maintain effective control over operating expenses.

Net loss for 2024 was $32.9 million, down from $36.2 million for 2023.

As of December 31, 2024, the Company had cash, cash equivalents, and available-for-sale securities of approximately $68.2 million. As noted above, in February 2025 the Company raised $57.5 million in a public follow-on offering, extending its cash runway through 2028 to support adoption and commercialization of Sera's PreTRM test.

Conference Call Information

Sera Prognostics will host a corresponding conference call and live webcast today to discuss fourth quarter and full year 2024 operational highlights, financial results and key topics at 5:00 p.m. Eastern Time. Individuals interested in listening to the conference call may do so by dialing the following:

US domestic callers: (800) 836-8184

International callers: (646) 357-8785

Webcast Registration Link: https://app.webinar.net/2velx8K3AMB

Live audio of the webcast will be available online from the Investors page of the Company's website at www.sera.com. The webcast will be archived on the Investors page and will be available for one year.

About Sera Prognostics, Inc.

Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera's mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM^® Test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is headquartered in Salt Lake City, Utah.

About Preterm Birth

Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2024 March of Dimes Report Card shows that, for the last six consecutive years, more than one in ten infants is born prematurely in the United States. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016.

About the PreTRM^® Test

The PreTRM^® Test is the only broadly validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM^® Test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM^® Test permits physicians to identify, during the weeks 18 through 20 of pregnancy, which women are at increased risk for preterm birth and its complications, enabling more informed, personalized clinical decisions based on each woman's individual risk. The PreTRM^® Test is ordered by a medical professional.

Sera, Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States and/or other countries.

Safe Harbor Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to extending the Company's cash runway through 2028; the Company's use of net proceeds from its capital raise offering; the Company expanding its commercial efforts in selected geographies in the United States, partnering with selected payers and providers to drive adoption of its PreTRM test; the Company accelerating preparations for expansion in the European Union; the Company funding additional studies designed to further increase adoption, including a potential submission to the U.S. FDA seeking broad approval of the PreTRM test; the date, time and content of the Company's quarterly earnings release and conference call; availability of the live audio of the conference call on the Company's website; and the company's strategic directives under the caption "About Sera Prognostics, Inc." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM Test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM Test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM Test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading "Risk Factors" contained in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our periodic and current reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. 

SERA PROGNOSTICS, INC. Condensed Statements of Operations (unaudited) (in thousands, except share and per share data)
		Three Months Ended								Year Ended
		December 31,								December 31,
		2024				2023				2024				2023
Revenue		$	24			$	41			$	77			$	306
Operating expenses:
Cost of revenue			32				24				82				210
Research and development			3,139				3,895				14,730				15,225
Selling and marketing			2,264				1,304				5,771				8,349
General and administrative			4,012				3,666				16,129				16,343
Total operating expenses			9,447				8,889				36,712				40,127
Loss from operations			(9,423)				(8,848)				(36,635)				(39,821)
Interest expense			(6)				(11)				(28)				(55)
Other income, net			850				934				3,765				3,634
Net loss		$	(8,579)			$	(7,925)			$	(32,898)			$	(36,242)
Net loss per share, basic and diluted		$	(0.25)			$	(0.25)			$	(0.99)			$	(1.16)
Weighted-average shares outstanding, basic and diluted			33,939,458				31,414,446				33,156,936				31,200,652

 

SERA PROGNOSTICS, INC. Condensed Balance Sheets (unaudited) (in thousands)
		December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	4,043			$	3,880
Marketable securities			42,193				45,199
Accounts receivable			34				160
Other receivables			19				11,310
Prepaid expenses and other current assets			1,311				795
Total current assets			47,600				61,344
Property and equipment, net			1,239				1,999
Long-term marketable securities			21,973				30,841
Intangible assets, net			1,026				—
Other assets			737				1,257
Total assets		$	72,575			$	95,441
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	1,969			$	1,046
Accrued and other current liabilities			2,384				2,722
Finance lease obligation, current portion			194				440
Deferred revenue			20,223				20,235
Total current liabilities			24,770				24,443
Finance lease obligation, net of current portion			2				196
Operating lease obligation, net of current portion			—				644
Total liabilities			24,772				25,283
Commitments and contingencies
Stockholders' equity:
Common stock, Class A and Class B			3				3
Additional paid-in capital			327,534				317,066
Accumulated other comprehensive income (loss)			60				(15)
Accumulated deficit			(279,794)				(246,896)
Total stockholders' equity			47,803				70,158
Total liabilities and stockholders' equity		$	72,575			$	95,441

 

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SOURCE Sera Prognostics, Inc.

FAQ

What were the key findings of Sera Prognostics' PRIME study for SERA stock in 2024?

The PRIME study showed 25% reduction in neonatal morbidity/mortality index and 18% reduction in hospital stay length, with 22% reduction in NICU admissions in the broader population.

How much revenue did SERA generate in Q4 2024 compared to Q4 2023?

SERA's Q4 2024 revenue was $24,000, down from $41,000 in Q4 2023.

What was the impact of SERA's February 2025 public offering?

The $57.5 million public offering extended SERA's cash runway through 2028, supporting US commercial expansion and European market preparation.

How did SERA's full-year 2024 net loss compare to 2023?

SERA's net loss improved to $32.9 million in 2024, down from $36.2 million in 2023.