SERA PROGNOSTICS REPORTS FOURTH QUARTER 2023 FINANCIAL RESULTS
Recent Highlights:
- Announced that the Data Safety Monitoring Board (DSMB) overseeing Sera's pivotal Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study recommended stopping enrollment due to efficacy, reporting that either of the co-primary endpoints met the stopping criteria for statistical significance at the pre-planned interim analysis. In final stages of preparing manuscript submission to premier medical publications.
- Working diligently with guideline groups to develop appropriate implementation plans while working toward publication of the PRIME study results.
- Made continued progress in development of product pipeline and PreTRM® sample collection and assay enhancements, which will provide simpler, cheaper collection methods and more efficient lab processing, with validations nearly complete and plans to launch in the coming months across certain initial geographies.
- Engaged in focused commercial activities ahead of PRIME data to build toward greater PreTRM® test adoption expectations in 2024-2025.
- Started new initiatives to build awareness with expectant mothers and develop patient-facing products and a predictive analytics tool that can establish direct relationships with women and expand and diversify revenue opportunities.
"We are looking forward to an exciting year of developments for Sera, including publication of our PRIME study results while executing on commercial expansion and our plans to establish direct relationships with expectant mothers," said Zhenya Lindgardt, President and CEO of
Fourth Quarter 2023 Financial Results
Fourth quarter 2023 revenue of
Total operating expenses were
Research and development expenses for the fourth quarter of 2023 were
Selling, general and administrative expenses for the fourth quarter of 2023 were
Net loss for the fourth quarter of 2023 was
Full Year 2023 Financial Results
Total full year 2023 revenue of
Total operating expenses were
Research and development expenses for 2023 were
Selling, general and administrative expenses for 2023 were
Net loss for 2023 was
As of
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About
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 2023 March of Dimes Report Card shows that, for the last five consecutive years, more than one in ten infants is born prematurely in the
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.
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 the Company being in the final stages of preparing a PRIME manuscript submission to premier medical publications; the Company working with guideline groups to develop appropriate implementation plans; sample collection and assay enhancements providing simpler, cheaper collection methods and more efficient lab processing, with validations nearly complete and plans to launch in the coming months; building toward greater PreTRM® test adoption expectations in 2024-2025; building awareness with expectant mothers and developing patient-facing products and a predictive analytics tool that can establish direct relationships with women and expand and diversify revenue opportunities; publication of our PRIME study results in 2024; commercial expansion; a future inflection in revenue growth; and the company's strategic directives under the caption "About
Condensed Statements of Operations (unaudited) (in thousands, except share and per share data) |
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|
Three Months Ended
|
|
Year Ended
|
||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue |
$ 41 |
|
$ 65 |
|
$ 306 |
|
$ 268 |
Operating expenses: |
|
|
|
|
|
|
|
Cost of revenue |
24 |
|
59 |
|
210 |
|
193 |
Research and development |
3,895 |
|
3,485 |
|
15,225 |
|
14,244 |
Selling and marketing |
1,304 |
|
3,055 |
|
8,349 |
|
14,699 |
General and administrative |
3,666 |
|
3,884 |
|
16,343 |
|
16,784 |
Total operating expenses |
8,889 |
|
10,483 |
|
40,127 |
|
45,920 |
Loss from operations |
(8,848) |
|
(10,418) |
|
(39,821) |
|
(45,652) |
Interest expense |
(11) |
|
(18) |
|
(55) |
|
(61) |
Other income, net |
934 |
|
690 |
|
3,634 |
|
1,527 |
Net loss |
$ (7,925) |
|
$ (9,746) |
|
$ (36,242) |
|
$ (44,186) |
Net loss per share, basic and diluted |
$ (0.25) |
|
$ (0.31) |
|
$ (1.16) |
|
$ (1.43) |
Weighted-average shares of common stock outstanding, basic and diluted |
31,414,446 |
|
31,017,472 |
|
31,200,652 |
|
30,943,426 |
Condensed Balance Sheets (unaudited) (in thousands) |
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|
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|
|
||
|
2023 |
|
2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ 3,880 |
|
$ 29,878 |
Marketable securities |
45,199 |
|
52,826 |
Accounts receivable |
160 |
|
113 |
Other receivables |
11,310 |
|
6,000 |
Prepaid expenses and other current assets |
795 |
|
1,308 |
Total current assets |
61,344 |
|
90,125 |
Property and equipment, net |
1,999 |
|
3,059 |
Long-term marketable securities |
30,841 |
|
21,329 |
Other assets |
1,257 |
|
1,816 |
Total assets |
$ 95,441 |
|
$ 116,329 |
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ 1,046 |
|
$ 1,548 |
Accrued and other current liabilities |
2,722 |
|
4,444 |
Finance lease obligation, current portion |
440 |
|
464 |
Deferred revenue |
20,235 |
|
9,082 |
Total current liabilities |
24,443 |
|
15,538 |
Finance lease obligation, net of current portion |
196 |
|
626 |
Operating lease obligation, net of current portion |
644 |
|
1,222 |
Total liabilities |
25,283 |
|
17,386 |
Commitments and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Common stock, Class A and Class B |
3 |
|
3 |
Additional paid-in capital |
317,066 |
|
310,575 |
Accumulated other comprehensive loss |
(15) |
|
(981) |
Accumulated deficit |
(246,896) |
|
(210,654) |
Total stockholders' equity |
70,158 |
|
98,943 |
Total liabilities and stockholders' equity |
$ 95,441 |
|
$ 116,329 |
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