SERA PROGNOSTICS REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS
Sera Prognostics reported its third quarter 2024 financial results, marking a revenue of $29,000, a drop from $42,000 in the same period of 2023. Operating expenses increased by 8% to $8.9 million, driven by product development and future sales initiatives. Net loss for the quarter was $7.9 million, up from $7.2 million in Q3 2023. Key activities included the analysis of the PRIME study data, an awareness campaign featuring TV programs with Dennis Quaid and Meg Ryan, and the introduction of home sample collection for PreTRM® testing. The company also launched a predictive analytics tool in beta testing and strengthened its commercial team. The transition to ambient whole blood collection aims to enhance scalability and unit economics. Sera Prognostics anticipates a sales inflection point with the publication of PRIME study results and expanded awareness of its test-and-treat strategy.
Sera Prognostics ha riportato i risultati finanziari del terzo trimestre 2024, registrando un fatturato di $29.000, in calo rispetto ai $42.000 nello stesso periodo del 2023. Le spese operative sono aumentate dell'8% a $8,9 milioni, a causa dello sviluppo del prodotto e delle iniziative di vendita future. La perdita netta per il trimestre è stata di $7,9 milioni, in aumento rispetto ai $7,2 milioni del terzo trimestre 2023. Tra le attività chiave ci sono state l'analisi dei dati dello studio PRIME, una campagna di sensibilizzazione con programmi TV con Dennis Quaid e Meg Ryan, e l'introduzione della raccolta di campioni a domicilio per il test PreTRM®. L'azienda ha anche lanciato uno strumento di analisi predittiva in fase di beta testing e ha rafforzato il proprio team commerciale. La transizione al prelievo di sangue intero ambientale ha l'obiettivo di migliorare la scalabilità e l'economia per unità. Sera Prognostics prevede un punto di svolta nelle vendite con la pubblicazione dei risultati dello studio PRIME e un'ampia consapevolezza della propria strategia di test e trattamento.
Sera Prognostics informó sobre sus resultados financieros del tercer trimestre de 2024, registrando ingresos de $29,000, una disminución de $42,000 en el mismo período de 2023. Los gastos operativos aumentaron un 8% a $8.9 millones, impulsados por el desarrollo de productos y futuras iniciativas de ventas. La pérdida neta para el trimestre fue de $7.9 millones, frente a $7.2 millones en el tercer trimestre de 2023. Las actividades clave incluyeron el análisis de los datos del estudio PRIME, una campaña de concienciación que presentaba programas de televisión con Dennis Quaid y Meg Ryan, y la introducción de la recolección de muestras en casa para las pruebas de PreTRM®. La empresa también lanzó una herramienta de análisis predictivo en pruebas beta y fortaleció su equipo comercial. La transición a la recolección de sangre entera ambiental busca mejorar la escalabilidad y la economía por unidad. Sera Prognostics anticipa un punto de inflexión en las ventas con la publicación de los resultados del estudio PRIME y una mayor conciencia de su estrategia de prueba y tratamiento.
세라 프로그노스틱스는 2024년 3분기 재무 결과를 보고하며 29,000달러의 매출을 기록하였고, 이는 2023년 같은 기간의 42,000달러에서 감소한 수치입니다. 운영 비용은 8% 증가하여 890만 달러에 달하며, 이는 제품 개발과 향후 판매 이니셔티브에 의해 촉발되었습니다. 해당 분기의 순손실은 790만 달러로, 2023년 3분기의 720만 달러에서 증가했습니다. 주요 활동으로는 PRIME 연구 데이터 분석, 데니 퀘이드와 메그 라이언이 출연하는 TV 프로그램을 포함한 인식 캠페인, 그리고 PreTRM® 테스트를 위한 자가 샘플 수집의 도입이 있었습니다. 회사는 예측 분석 도구를 베타 테스트로 출시하고 상업 팀을 강화했습니다. 환경적 전체 혈액 수집으로의 전환은 확장성과 단위 경제성을 개선하는 것을 목표로 합니다. 세라 프로그노스틱스는 PRIME 연구 결과의 발표와 자신의 테스트 및 치료 전략에 대한 인식 확대와 함께 판매의 전환점을 예상하고 있습니다.
Sera Prognostics a publié ses résultats financiers pour le troisième trimestre 2024, enregistrant un chiffre d'affaires de 29 000 $, en baisse par rapport à 42 000 $ au cours de la même période en 2023. Les dépenses opérationnelles ont augmenté de 8 % pour atteindre 8,9 millions de dollars, en raison du développement de produits et des initiatives de vente futures. La perte nette pour le trimestre s'est élevée à 7,9 millions de dollars, contre 7,2 millions de dollars au troisième trimestre 2023. Les principales activités ont compris l'analyse des données de l'étude PRIME, une campagne de sensibilisation mettant en vedette des programmes télévisés avec Dennis Quaid et Meg Ryan, et l'introduction de la collecte d'échantillons à domicile pour le test PreTRM®. L'entreprise a également lancé un outil d'analyse prédictive en phase de test bêta et renforcé son équipe commerciale. La transition vers la collecte de sang entier dans l'environnement vise à améliorer la scalabilité et l'économie d'unité. Sera Prognostics anticipe un point d'inflexion des ventes avec la publication des résultats de l'étude PRIME et une sensibilisation accrue à sa stratégie de test et de traitement.
Sera Prognostics hat seine finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, mit einem Umsatz von 29.000 Dollar, ein Rückgang von 42.000 Dollar im gleichen Zeitraum 2023. Die Betriebskosten stiegen um 8% auf 8,9 Millionen Dollar, getrieben durch Produktentwicklung und zukünftige Verkaufsinitiativen. Der Nettoverlust für das Quartal betrug 7,9 Millionen Dollar, im Vergleich zu 7,2 Millionen Dollar im dritten Quartal 2023. Zu den Hauptaktivitäten gehörten die Analyse der PRIME-Studie Daten, eine Sensibilisierungskampagne mit Fernsehprogrammen mit Dennis Quaid und Meg Ryan sowie die Einführung der Heimprobenentnahme für den PreTRM®-Test. Das Unternehmen hat auch ein Prognosetool in der Beta-Phase eingeführt und sein Vertriebsteam gestärkt. Der Übergang zur Umgebungsblutentnahme zielt darauf ab, die Skalierbarkeit und Wirtschaftlichkeit pro Einheit zu verbessern. Sera Prognostics erwartet einen Wendepunkt im Verkauf mit der Veröffentlichung der Ergebnisse der PRIME-Studie und einer erweiterten Bekanntheit seiner Test- und Behandlungsstrategie.
- Introduction of home sample collection for PreTRM® testing is expected to drive consumer-initiated sales.
- Strengthened commercial team with key hires in sales and marketing.
- Transition to ambient whole blood collection improving scalability and unit economics.
- Predictive analytics tool in beta testing offering personalized insights.
- Revenue decreased to $29,000 from $42,000 year-over-year.
- Operating expenses increased by 8% to $8.9 million.
- Net loss increased to $7.9 million from $7.2 million in the prior year.
Recent Highlights:
- Data analysis for full Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study underway after database was locked in September and now seeking publication of results in connection with key pregnancy and maternal health conferences in early 2025 and manuscript submission to a quality peer-reviewed journal.
- Awareness campaign activated with TV programs by Viewpoint with Dennis Quaid and Empowered with Meg Ryan. These programs are expected to be distributed to public television stations in all 50 states, and in over 84 million homes via MSNBC, CNBC, CNN or similar networks broadly supporting Sera's goal of informing the public about our test-and-treat offering and how it can support improved pregnancy outcomes.
- Beginning October 1, 2024, and as featured in a Time Magazine article, began enabling access to PreTRM® testing through the Company's website, with home sample collection. The expectant mother then will receive the results for discussion with her physician. This new capability is expected to drive consumer-initiated sales supported by the awareness campaign.
- To provide education, build relationships with pregnant women and support Sera's product offerings, predictive analytics offering is now in beta testing, engaging women with informative reports based on the data from millions of pregnancy experiences, and personalized insights into pregnancies like theirs.
- Strengthened commercial team with select key hires in sales and marketing to drive test adoption and sales.
- Transition to ambient whole blood collection continues to yield improved physician and patient access to PreTRM, significantly lower cost of goods, and significantly increased lab capacity, to enhance scalability of the test and improve unit economics in anticipation of a commercial inflection point in Sera's business.
"We are successfully putting in place the key prerequisites for commercial success in anticipation of our full PRIME study results achieving publication and further illustrating the benefits of our PreTRM capabilities and test-and-treat strategy," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "Once expanded awareness and care guidelines have occurred, our multi-pronged approach to the maternal care market we serve is expected to create a sales inflection in our business coupled with more profitable margin and revenue growth as we showcase our unique platform as The Pregnancy Company."
Third Quarter 2024 Financial Results
Third quarter 2024 revenue was
Research and development expenses for the third quarter of 2024 were
Selling, general and administrative expenses for the third quarter of 2024 were
Net loss for the quarter was
Conference Call Information
Sera Prognostics will host a corresponding conference call and live webcast today to discuss third quarter 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/L6rDpZAVdM8
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, 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 publication of results in connection with key pregnancy and maternal health conferences in early 2025 and manuscript submission to a quality peer-reviewed journal; distribution of Sera-sponsored TV programs to public television stations in all 50 states, and in over 84 million homes via MSNBC, CNBC, CNN or similar networks; the new consumer-initiated testing channel driving sales supported by the awareness campaign; a strengthened commercial team with select key hires in sales and marketing driving test adoption and sales; the transition to ambient whole blood collection yielding improved physician and patient access to PreTRM, significantly lower cost of goods, and significantly increased lab capacity, enhanced scalability of the test and improved unit economics; the full PRIME study results achieving publication and further illustrating the benefits of our PreTRM capabilities and test-and-treat strategy; a sales inflection in the Company's business coupled with more profitable margin and 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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenue | $ | 29 | $ | 42 | $ | 53 | $ | 265 | ||||||||
Operating expenses: | ||||||||||||||||
Cost of revenue | 13 | 44 | 50 | 186 | ||||||||||||
Research and development | 3,502 | 3,539 | 11,591 | 11,330 | ||||||||||||
Selling and marketing | 1,181 | 1,355 | 3,507 | 7,045 | ||||||||||||
General and administrative | 4,195 | 3,288 | 12,117 | 12,677 | ||||||||||||
Total operating expenses | 8,891 | 8,226 | 27,265 | 31,238 | ||||||||||||
Loss from operations | (8,862) | (8,184) | (27,212) | (30,973) | ||||||||||||
Interest expense | (5) | (14) | (22) | (44) | ||||||||||||
Other income, net | 948 | 988 | 2,915 | 2,700 | ||||||||||||
Net loss | $ | (7,919) | $ | (7,210) | $ | (24,319) | $ | (28,317) | ||||||||
Net loss per share, basic and diluted | $ | (0.24) | $ | (0.23) | $ | (0.74) | $ | (0.91) | ||||||||
Weighted-average shares outstanding, basic and diluted | 33,522,726 | 31,286,148 | 32,894,191 | 31,128,604 | ||||||||||||
SERA PROGNOSTICS, INC. Condensed Balance Sheets (unaudited) (in thousands) | ||||||||
September 30, | December 31, | |||||||
2024 | 2023 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 2,684 | $ | 3,880 | ||||
Marketable securities | 47,068 | 45,199 | ||||||
Accounts receivable | 79 | 160 | ||||||
Other receivables | – | 11,310 | ||||||
Prepaid expenses and other current assets | 1,276 | 795 | ||||||
Total current assets | 51,107 | 61,344 | ||||||
Property and equipment, net | 1,428 | 1,999 | ||||||
Long-term marketable securities | 24,591 | 30,841 | ||||||
Other assets | 1,875 | 1,257 | ||||||
Total assets | $ | 79,001 | $ | 95,441 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,378 | $ | 1,046 | ||||
Accrued and other current liabilities | 2,273 | 2,722 | ||||||
Finance lease obligation, current portion | 305 | 440 | ||||||
Deferred revenue | 20,226 | 20,235 | ||||||
Total current liabilities | 24,182 | 24,443 | ||||||
Finance lease obligation, net of current portion | 3 | 196 | ||||||
Operating lease obligation, net of current portion | 165 | 644 | ||||||
Total liabilities | 24,350 | 25,283 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Common stock, Class A and Class B | 3 | 3 | ||||||
Additional paid-in capital | 325,571 | 317,066 | ||||||
Accumulated other comprehensive income (loss) | 292 | (15) | ||||||
Accumulated deficit | (271,215) | (246,896) | ||||||
Total stockholders' equity | 54,651 | 70,158 | ||||||
Total liabilities and stockholders' equity | $ | 79,001 | $ | 95,441 | ||||
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SOURCE Sera Prognostics, Inc.
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