SERA PROGNOSTICS REPORTS FOURTH QUARTER 2022 FINANCIAL RESULTS
Sera Prognostics, focused on maternal and neonatal health, reported its financial results for Q4 and full year 2022.
Q4 revenue increased to $65,000, up from $26,000 in Q4 2021. Full-year 2022 revenue reached $268,000, compared to $82,000 in 2021. Total operating expenses decreased to $10.5 million in Q4, down from $12.6 million in Q4 2021; however, full-year expenses rose to $45.9 million, up from $35.5 million.
The net loss for Q4 was $9.7 million, improved from $12.5 million the previous year. The company ended 2022 with approximately $104 million in cash and equivalents.
- Q4 2022 revenue increased to $65,000 from $26,000 in Q4 2021.
- Full-year revenue rose significantly to $268,000 compared to $82,000 in 2021.
- Operating expenses decreased to $10.5 million in Q4, down from $12.6 million in Q4 2021.
- The company ended 2022 with approximately $104 million in cash and equivalents.
- Key clinical trials, including the AVERT PRETERM TRIAL, reported positive outcomes.
- Total operating expenses for 2022 increased to $45.9 million, up from $35.5 million in 2021.
- Net loss for Q4 2022 was $9.7 million, despite improvement from $12.5 million in Q4 2021.
- Research and development expenses for 2022 rose to $14.2 million from $11.0 million in 2021.
Recent Highlights:
- Announced positive top-line results from the AVERT PRETERM TRIAL (Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls), conducted at ChristianaCare in
Wilmington, Delaware . The results demonstrated the generalizability of the PreTRM® test-and-treat strategy in achieving meaningful clinical results in widely diverseU.S. populations toward significant improvement in neonatal health outcomes and hospital length-of-stay. - Announced the publication of results from a clinical utility and cost-effectiveness modeling study, ACCORDANT (Analyses aCross Congruent studies ReDucing Adverse pregNancy ouTcomes), which, based on rigorous clinical utility health economic analysis, illustrated the impact of Sera's test-and-treat strategy and its specific benefits in underserved racial and ethnic populations. By combining the PreTRM® Test with enhanced prenatal care management, real progress may be possible in better serving these populations to enable better medical outcomes.
- Validated preeclampsia risk predictor, with results made available publicly and being prepared for submission to a scientific journal.
- Surpassed the required 2,800 PRIME study subject enrollment, which enables the interim look analysis by year end.
"We are pleased with the growing body of data showing the clinical utility and cost effectiveness of the PreTRM® Test in mitigating the negative health and economic consequences of preterm delivery," said
Fourth Quarter 2022 Financial Results
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Full Year 2022 Financial Results
Total full year 2022 revenue of
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As of
Conference Call Information
US domestic callers: (866) 218-2405
International callers: (412) 902-6607
Webcast Registration Link: https://app.webinar.net/7E3P1Ox6ANJ
Live audio of the webcast will be available online from the Investors page of the Company's website at www.seraprognostics.com. The webcast will be archived on the Investors page and will be available for one year.
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 2022 March of Dimes Report Card shows that, for the last four consecutive years, more than one in ten infants is born prematurely. 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
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 interim look analysis being enabled by year end; the growing body of data showing the clinical utility and cost effectiveness of the PreTRM® Test; the AVERT PRETERM TRIAL results being prepared for submission to a scientific journal for publication; the conference call and live webcast being held today and audio of the webcast being available on the Company's Investors page for one year; and the company's strategic directives under the caption "About
Condensed Statements of Operations (unaudited) (in thousands, except share and per share data) | |||||||
Three Months Ended | Year Ended | ||||||
2022 | 2021 | 2022 | 2021 | ||||
Revenue | $ 65 | $ 26 | $ 268 | $ 82 | |||
Operating expenses: | |||||||
Cost of revenue | 59 | 14 | 193 | 37 | |||
Research and development | 3,485 | 3,075 | 14,244 | 11,019 | |||
Selling and marketing | 3,055 | 4,548 | 14,699 | 10,328 | |||
General and administrative | 3,884 | 4,936 | 16,784 | 14,093 | |||
Total operating expenses | 10,483 | 12,573 | 45,920 | 35,477 | |||
Loss from operations | (10,418) | (12,547) | (45,652) | (35,395) | |||
Interest expense | (18) | (2) | (61) | (746) | |||
Other income, net | 690 | 65 | 1,527 | 1,132 | |||
Net loss | $ (9,746) | $ (12,484) | $ (44,186) | $ (35,009) | |||
Net loss per share, basic and diluted | $ (0.31) | $ (0.41) | $ (1.43) | $ (2.33) | |||
Weighted-average shares of common stock outstanding, basic and diluted | 31,017,472 | 30,718,121 | 30,943,426 | 15,003,144 |
Condensed Balance Sheets (unaudited) (in thousands) | |||
2022 | 2021 | ||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 29,878 | $ 58,932 | |
Marketable securities | 52,826 | 46,183 | |
Accounts receivable | 113 | 27 | |
Other receivables | 6,000 | 3,116 | |
Prepaid expenses and other current assets | 1,308 | 1,993 | |
Total current assets | 90,125 | 110,251 | |
Property and equipment, net | 3,059 | 1,773 | |
Long-term marketable securities | 21,329 | 34,848 | |
Other assets | 1,816 | 157 | |
Total assets | $ 116,329 | $ 147,029 | |
Liabilities and Stockholders' Equity | |||
Current liabilities: | |||
Accounts payable | $ 1,548 | $ 1,197 | |
Accrued and other current liabilities | 4,444 | 3,885 | |
Deferred rent, current portion | — | 139 | |
Finance lease obligation, current portion | 464 | 74 | |
Deferred revenue | 9,082 | 3,116 | |
Total current liabilities | 15,538 | 8,411 | |
Finance lease obligation, net of current portion | 626 | 54 | |
Operating lease obligation, net of current portion | 1,222 | — | |
Total liabilities | 17,386 | 8,465 | |
Commitments and contingencies | |||
Stockholders' equity: | |||
Common stock, Class A and Class B | 3 | 3 | |
Additional paid-in capital | 310,575 | 305,212 | |
Accumulated other comprehensive loss | (981) | (183) | |
Accumulated deficit | (210,654) | (166,468) | |
Total stockholders' equity | 98,943 | 138,564 | |
Total liabilities and stockholders' equity | $ 116,329 | $ 147,029 |
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