SERA PROGNOSTICS REPORTS FOURTH QUARTER 2023 FINANCIAL RESULTS
- Positive recommendation to stop enrollment in the PRIME study due to efficacy.
- Preparing to publish study results in premier medical publications.
- Enhancing product pipeline with PreTRM sample collection and assay improvements.
- Engaged in commercial activities to boost PreTRM adoption in 2024-2025.
- Initiatives to build awareness and develop patient-facing products and predictive analytics tools.
- Revenue growth expected from commercial expansion and new product launches.
- Decline in Q4 2023 revenue compared to the same period in 2022.
- Net loss reported for Q4 2023 and full year 2023.
- Increase in research and development expenses for 2023 due to higher clinical study costs.
Insights
The reported financials of Sera Prognostics Inc. indicate a mixed landscape. While revenue has seen a marginal increase year-over-year, the company's operating expenses have decreased significantly. This suggests that the company's efforts to streamline operations and focus its commercial strategy are yielding some cost-saving results. However, the reduction in expenses has not yet translated into profitability, as evidenced by the net loss figures. The company's cash reserves are substantial, which provides a buffer for continued R&D and commercial activities. It is essential to monitor how these financial dynamics play out in the context of the company's strategic initiatives, especially with the expected launch of new product enhancements and commercial expansion.
The recommendation from the DSMB to stop enrollment in the PRIME study due to efficacy is a significant milestone. It suggests that the study's co-primary endpoints have been met, which could potentially lead to a paradigm shift in maternal and neonatal health management. The focus on developing patient-facing products and predictive analytics tools indicates a strategic move towards personalized healthcare. For stakeholders, the successful validation and launch of these products could mean diversifying revenue streams and potentially improving patient outcomes. However, the real-world effectiveness of these tools and their market adoption will be critical factors in assessing the long-term impact on the company's financial health.
From a market perspective, Sera Prognostics is positioning itself in a niche but vital segment of healthcare. The advancements in their product pipeline and the strategic push towards direct engagement with expectant mothers could tap into unmet needs within the maternal health space. The focus on enhancing the PreTRM® test and making it more accessible suggests that Sera is aiming to increase market penetration. Nevertheless, successful commercialization will depend on the receptiveness of the medical community, insurance coverage and the ability to effectively communicate the value proposition to both healthcare providers and patients. Tracking competitor activities and market trends will be essential in evaluating the potential for Sera's revenue growth and market share expansion.
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 Sera Prognostics. "We expect these activities and advancements in our product pipeline to complement what we believe is our leading position in the area of maternal and neonatal health and pave the way for a future inflection in revenue growth."
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 December 31, 2023, the Company had cash, cash equivalents, and available-for-sale securities of approximately
Conference Call Information
Sera Prognostics will host a corresponding conference call and live webcast today to discuss fourth quarter and full year 2023 operational highlights, financial results and key topics at 5:00 p.m. Eastern Time. The Company notes that, although this will not be referred to in the prepared remarks during the call, it has posted an updated slide presentation to the investor relations page of its website at www.seraprognostics.com. Individuals interested in listening to the conference call may do so by dialing the following:
US domestic callers: (866) 218-2405
International callers: (412) 902-6607
Webcast Registration Link: https://app.webinar.net/Za419djMmLE
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 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,
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.
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 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 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; the COVID-19 pandemic and its potential lingering impact on our operations, as well as the business or operations of third parties with whom we conduct business; 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 Final Prospectus on Form S-1, which was filed with the Securities and Exchange Commission on July 14, 2021, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, or Current Reports on Form 8-K. 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 | ||||||
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 | |||
SERA PROGNOSTICS, INC. Condensed Balance Sheets (unaudited) (in thousands) | |||
December 31, | |||
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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SOURCE Sera Prognostics, Inc.
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