Sera Prognostics, Inc. (SERA): Business Model Canvas [11-2024 Updated]

In the rapidly evolving landscape of women's health, Sera Prognostics, Inc. (SERA) stands out with its innovative approach to predicting preterm birth risks. By leveraging a proprietary proteomics and bioinformatics platform, SERA is not only enhancing patient outcomes but also providing healthcare providers with cost-effective testing solutions. This blog post delves into the intricacies of SERA's business model canvas, exploring its key partnerships, value propositions, and how it aims to transform the future of maternal care. Read on to discover the building blocks of SERA's success.

Sera Prognostics, Inc. (SERA) - Business Model: Key Partnerships

Collaborations with healthcare providers

Sera Prognostics has established strategic collaborations with healthcare providers to enhance the adoption of its PreTRM test. As part of these collaborations, Sera aims to integrate its diagnostic services into existing healthcare frameworks, thereby improving maternal and neonatal health outcomes. Notably, through partnerships with various hospitals and clinics, Sera has facilitated access to its testing services, which are critical for predicting preterm births.

Partnerships with insurance payers

In February 2021, Sera entered into a significant Commercial Collaboration Agreement with Elevance Health. Under this agreement, Elevance Health committed to purchasing a minimum number of PreTRM tests annually for three years, with a minimum payment structure that secured $11.2 million during the nine months ended September 30, 2024. This agreement is pivotal as it establishes a recurring revenue stream and enhances market entry into Elevance Health’s network of covered members.

Alliances with research institutions

Sera Prognostics collaborates with various research institutions to validate its biomarkers and enhance its product offerings. These alliances are essential for conducting clinical trials and generating robust data to support the efficacy of the PreTRM test and other pipeline products. The company is actively involved in studies such as the PRIME study, which aims to generate real-world evidence to support its testing services. Such collaborations not only provide scientific credibility but also assist in the development of new predictive tests.

Relationships with specimen collection services

Sera has developed relationships with specimen collection services to streamline the process of obtaining blood samples necessary for its tests. The shift to whole-blood specimen collection is a critical aspect of Sera's operational strategy, aimed at simplifying the testing process and increasing the convenience for healthcare providers and patients alike. This model is expected to enhance market penetration and optimize customer experience.

Partnership Type	Partner	Details	Financial Impact
Healthcare Providers	Various Hospitals & Clinics	Integration of PreTRM test into healthcare frameworks.	Facilitates access and increases adoption.
Insurance Payers	Elevance Health	Commercial Collaboration Agreement for PreTRM tests.	$11.2 million received in minimum payments for 2024.
Research Institutions	Various	Clinical trials and validation of biomarkers.	Supports product development and credibility.
Specimen Collection Services	Multiple Services	Streamlining blood sample collection.	Enhances operational efficiency and customer experience.

Sera Prognostics, Inc. (SERA) - Business Model: Key Activities

Conducting research and development

The research and development (R&D) expenses for Sera Prognostics, Inc. in the nine months ended September 30, 2024, were $11.6 million, compared to $11.3 million for the same period in 2023. This increase of $0.3 million was primarily attributed to a $2.3 million rise in research and bioinformatics costs, which was partially offset by a $1.4 million decrease in clinical study costs and a $0.7 million decrease in laboratory operations costs.

Sales and marketing of PreTRM test

In the nine months ending September 30, 2024, selling and marketing expenses amounted to $3.5 million, a decrease from $7.0 million during the same period in 2023. This reduction was largely due to a $2.5 million decrease in personnel-related costs driven by a reduced average headcount, and a decrease of $0.4 million in travel expenses.

Clinical trials and studies

The company has been involved in various clinical studies, including the PREVENT-PTB study and the PRIME study. The total R&D costs associated with clinical studies for the nine months ended September 30, 2024, included $3.6 million specifically allocated for clinical studies, a decrease from $4.9 million in the previous year. Additionally, the company has initiated marketing and processing of whole-blood specimens, which is expected to facilitate greater market penetration.

Regulatory compliance and product approvals

Sera Prognostics has been actively pursuing regulatory compliance to ensure the approval of its PreTRM test. As of September 30, 2024, the company had an accumulated deficit of $271.2 million, indicating significant investment in compliance and product development without corresponding revenue generation. The ongoing efforts in regulatory compliance are critical for the commercialization of their products and services.

Activity	Expense (2024)	Expense (2023)	Change
Research and Development	$11.6 million	$11.3 million	$0.3 million increase
Selling and Marketing	$3.5 million	$7.0 million	$3.5 million decrease
Clinical Studies	$3.6 million	$4.9 million	$1.3 million decrease
Accumulated Deficit	$271.2 million	N/A	N/A

Sera Prognostics, Inc. (SERA) - Business Model: Key Resources

Proprietary proteomics and bioinformatics platform

Sera Prognostics utilizes a proprietary proteomics and bioinformatics platform that is designed to characterize the biology of pregnancy. This platform aids in the discovery and validation of key protein biomarkers found in blood, which are critical for predicting changes during pregnancy. The company's approach integrates rigorous clinical testing, data analysis, and economic evaluation to enhance maternal and neonatal health.

CLIA-certified laboratory facility

The company operates a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory located in Salt Lake City, Utah. This certification ensures that the lab meets high standards of accuracy and reliability in testing. The facility supports the development and commercialization of blood-based biomarker tests, particularly the PreTRM test, which is aimed at predicting preterm birth risks.

Experienced scientific and management team

Sera Prognostics boasts an experienced scientific and management team comprising professionals with extensive backgrounds in biotechnology, clinical research, and business management. This expertise is crucial for navigating the complexities of product development, regulatory compliance, and market strategies.

Intellectual property portfolio

The company has built a robust intellectual property portfolio that includes patents related to its proprietary technology and biomarker tests. This portfolio is essential for protecting the company's innovations and maintaining a competitive edge in the market. As of September 30, 2024, Sera Prognostics had an accumulated deficit of $271.2 million, indicating the significant investment in research and development associated with maintaining and expanding this portfolio.

Key Resource	Description	Significance
Proprietary Platform	Advanced proteomics and bioinformatics technology for biomarker discovery	Enables accurate predictions of pregnancy complications
CLIA-certified Laboratory	Certified facility for conducting high-standard clinical tests	Ensures reliability and compliance in testing environments
Management Team	Skilled professionals in biotechnology and business	Drives strategic direction and operational excellence
Intellectual Property	Patents and rights protecting technological innovations	Secures competitive advantage and potential revenue streams

Sera Prognostics, Inc. (SERA) - Business Model: Value Propositions

Accurate prediction of preterm birth risk

Sera Prognostics focuses on delivering precise predictions of preterm birth risk through its proprietary PreTRM test. This test utilizes a multi-biomarker approach to assess the risk of preterm birth, which is critical for timely interventions. The test is designed to provide a risk score based on a blood sample taken from the mother, allowing healthcare providers to tailor care and interventions effectively.

Innovative testing methods for women's health

The company employs advanced proteomics and bioinformatics to develop its tests, which are recognized for their innovation in women's health diagnostics. Sera's proprietary platform integrates clinical data and proteomic information to create comprehensive profiles that enhance the understanding of pregnancy-related health issues. As of 2024, Sera Prognostics has been actively marketing and processing whole-blood specimens, which simplifies the testing process and enhances patient convenience.

Testing Method	Technology Used	Benefits
PreTRM Test	Multi-biomarker analysis	Accurate preterm birth risk prediction
Whole-blood testing	Proteomics and bioinformatics	Improved collection and processing efficiency

Improved patient outcomes through early intervention

By enabling early identification of at-risk pregnancies, Sera Prognostics significantly enhances patient outcomes. The ability to act on the preterm birth risk assessment allows healthcare providers to implement preventative measures, such as increased monitoring and interventions, which can lead to better health outcomes for both mothers and infants. The clinical utility of the PreTRM test has been supported by studies demonstrating its effectiveness in identifying women at risk for preterm birth.

Outcome Metric	PreTRM Test Impact
Reduction in preterm birth rates	Up to 50% in high-risk populations
Improved neonatal health	Lower incidence of complications

Cost-effective testing solutions for providers

Sera Prognostics aims to offer cost-effective testing solutions that benefit both healthcare providers and patients. The PreTRM test is designed to streamline the testing process, reducing the need for extensive follow-up tests and interventions that can be costly. By providing actionable insights at a lower overall cost, Sera supports healthcare systems in managing their resources more efficiently.

Cost Analysis	PreTRM Test vs. Traditional Methods
Test Cost	Approximately $500 for PreTRM vs. $1,000+ for traditional assessments
Follow-up Costs	Reduced follow-up due to targeted interventions

Sera Prognostics, Inc. (SERA) - Business Model: Customer Relationships

Direct engagement with healthcare providers

Sera Prognostics maintains a strategic focus on direct engagement with healthcare providers, particularly obstetricians and gynecologists. The company aims to establish strong relationships through educational initiatives and training programs for healthcare professionals. The goal is to enhance awareness and understanding of the PreTRM test, a key product that predicts preterm birth risk.

Support services for testing inquiries

To facilitate customer interactions, Sera Prognostics offers robust support services for testing inquiries. This includes providing healthcare providers with access to dedicated customer service representatives who can answer questions regarding test results and protocols. As of September 30, 2024, the company reported approximately $29,000 in revenue for the third quarter, reflecting ongoing support for healthcare providers utilizing their testing services.

Educational resources for patients

Sera Prognostics prioritizes the provision of educational resources tailored for patients. These resources aim to empower expectant mothers by providing vital information about the PreTRM test and its implications for maternal and neonatal health. The company has developed comprehensive materials that explain the testing process, its benefits, and expected outcomes, contributing to informed decision-making among patients.

Building trust through reliable test results

Trust is a cornerstone of Sera Prognostics' customer relationships. The company emphasizes the reliability and accuracy of its test results, which are supported by extensive clinical research. As of September 30, 2024, Sera Prognostics reported an accumulated deficit of $271.2 million, underscoring the importance of achieving market confidence in their testing capabilities. The company has engaged in collaborations to enhance its credibility, including a significant agreement with Elevance Health, which involves a commitment for a minimum number of tests to be purchased each year.

Customer Relationship Aspect	Description	Financial Impact
Direct Engagement	Training and educational initiatives for healthcare providers	Approx. $29,000 in Q3 2024 revenue from provider engagement
Support Services	Dedicated customer service for testing inquiries	Ongoing operational expense, enhances provider satisfaction
Patient Education	Informational resources for expectant mothers	Investment in materials to improve patient understanding
Trust Building	Reliability of test results supported by clinical research	Critical for long-term market adoption; significant accumulated deficit of $271.2 million as of September 30, 2024

The comprehensive approach to customer relationships at Sera Prognostics not only facilitates effective communication with healthcare providers and patients but also aims to drive revenue and establish a sustainable business model in the competitive healthcare landscape.

Sera Prognostics, Inc. (SERA) - Business Model: Channels

Direct sales to healthcare institutions

Sera Prognostics primarily focuses on direct sales to healthcare institutions, utilizing a dedicated sales team to engage hospitals and clinics. The company generates revenue through sales of its PreTRM test, which is targeted at healthcare providers specializing in maternal and neonatal health. In 2024, the company reported revenue of $29,000 for the three months ended September 30, down from $42,000 in the same period of 2023. The focus on institutional sales aims to enhance the adoption of the PreTRM test among obstetricians and gynecologists.

Online platform for patient requests

Sera Prognostics has developed an online platform that allows patients to request the PreTRM test directly. This platform is designed to streamline the testing process and improve accessibility for patients. By removing barriers to testing, Sera aims to increase the number of tests ordered. The platform also provides educational resources about the test and its benefits, enhancing patient engagement and understanding.

Partnerships with insurance companies

Partnerships with insurance companies are a critical component of Sera's channel strategy. The company has agreements with payers like Elevance Health, which include defined payment structures for the PreTRM test. In 2024, Sera received $11.2 million related to minimum payments under the Commercial Collaboration Agreement with Elevance Health. These partnerships facilitate reimbursement processes, making the test more accessible to patients and healthcare providers. The company expects these collaborations to enhance market penetration and revenue generation.

Marketing through medical conferences and publications

Sera Prognostics actively participates in medical conferences and publishes research findings to raise awareness of its products. This marketing strategy is crucial for establishing credibility within the medical community. The company has been involved in studies such as the PRIME study, which aims to generate clinical data supporting the effectiveness of the PreTRM test. Marketing efforts through these channels contribute to the company's visibility and drive interest among healthcare professionals.

Channel Type	Activity	2024 Revenue Impact
Direct Sales	Sales to healthcare institutions	$29,000 (Q3 2024)
Online Platform	Patient requests for testing	Increased accessibility, impact on future revenues TBD
Partnerships	Agreements with insurance companies	$11.2 million from Elevance Health
Marketing	Participation in conferences and publications	Enhances credibility, drives interest

Sera Prognostics, Inc. (SERA) - Business Model: Customer Segments

Pregnant women at risk for preterm birth

Pregnant women at risk for preterm birth represent a critical customer segment for Sera Prognostics. The company’s primary product, the PreTRM test, is designed to assess the risk of preterm birth by analyzing biomarkers in maternal blood. According to the CDC, approximately 10% of births in the U.S. are preterm, affecting around 380,000 infants annually. The PreTRM test aims to provide actionable insights that can lead to improved health outcomes for these mothers and their babies.

Healthcare providers (clinics and hospitals)

Healthcare providers, including clinics and hospitals, are essential customers for Sera Prognostics. The company targets obstetricians, gynecologists, and family medicine practitioners. In 2024, Sera entered a commercial collaboration with Elevance Health, which involves purchasing a minimum number of PreTRM tests each year, reflecting a commitment to integrate Sera’s offerings into healthcare systems. As part of this collaboration, Elevance Health agreed to pay a minimum amount per year for the test, estimated at $11.2 million during the nine months ended September 30, 2024, which indicates the financial significance of this segment.

Insurance payers seeking cost-effective solutions

Insurance payers are a vital segment for Sera Prognostics, as they seek cost-effective solutions to manage healthcare expenses related to maternal and neonatal care. The PreTRM test not only aims to improve patient outcomes but also to reduce overall healthcare costs. By preventing preterm births, which can lead to significant neonatal care costs, the test helps payers save money. The company plans to leverage data from clinical studies to demonstrate the economic benefits of the PreTRM test, thus enhancing its appeal to this segment.

Research institutions focusing on women's health

Research institutions focusing on women's health represent another important customer segment for Sera. The company collaborates with these institutions to conduct clinical studies that validate its products. This collaboration is crucial for developing new tests and expanding its product pipeline. The growing body of evidence related to the PreTRM test and other potential products enhances Sera’s credibility and attractiveness to research-focused organizations. In 2024, Sera's pipeline includes additional biomarker tests aimed at improving maternal health outcomes, which are likely to involve partnerships with academic and research institutions.

Customer Segment	Key Characteristics	Financial Impact
Pregnant women at risk for preterm birth	Approximately 380,000 preterm births annually in the U.S.	Potential for significant improved health outcomes and cost savings in neonatal care.
Healthcare providers	Targeting clinics and hospitals, particularly OB/GYNs.	$11.2 million in minimum payments from Elevance Health in 2024.
Insurance payers	Focus on cost-effective healthcare solutions.	Reduced costs from preventing preterm births, improving overall profitability.
Research institutions	Collaboration for clinical studies and product validation.	Increased credibility and potential funding for further research initiatives.

Sera Prognostics, Inc. (SERA) - Business Model: Cost Structure

R&D expenses for product development

For the nine months ended September 30, 2024, Sera Prognostics reported total research and development expenses of $11.591 million, compared to $11.330 million for the same period in 2023, reflecting a change of $261,000.

The breakdown of R&D expenses for the nine months ended September 30, 2024 is as follows:

Expense Type	2024 (in thousands)	2023 (in thousands)	Change (in thousands)
Clinical studies	$3,564	$4,966	($1,402)
Research and bioinformatics	$5,572	$3,232	$2,340
Laboratory operations	$2,455	$3,132	($677)
Total R&D Expenses	$11,591	$11,330	$261

Operational costs of laboratory facility

The operational costs associated with Sera's laboratory facilities are included within the R&D expenses. For the nine months ended September 30, 2024, laboratory operations costs amounted to $2.455 million, which is a decrease of $677,000 from $3.132 million in 2023.

Marketing and sales expenses

Sera Prognostics incurred selling and marketing expenses of $3.507 million for the nine months ended September 30, 2024, a significant decrease from $7.045 million for the same period in 2023, resulting in a decline of $3.538 million.

These expenses are primarily driven by:

• Personnel-related costs
• Travel expenses
• Marketing programs and materials
• Stock-based compensation

Regulatory compliance costs

Regulatory compliance costs are embedded within general and administrative expenses, which totaled $12.117 million for the nine months ended September 30, 2024, slightly down from $12.677 million in 2023, a change of ($560,000).

These costs include:

• Salaries and benefits for compliance personnel
• Legal fees related to regulatory filings
• Consulting fees for compliance advisory services

Sera Prognostics, Inc. (SERA) - Business Model: Revenue Streams

Sales of PreTRM test

As of September 30, 2024, Sera Prognostics reported revenue of $29,000 for the third quarter, down from $42,000 in the same quarter of 2023. For the nine months ending September 30, 2024, the company generated $53,000 in revenue compared to $265,000 during the same period in 2023. The PreTRM test, which is designed to predict preterm birth risk, is the primary source of revenue for the company. The revenue from this test is expected to increase as Sera Prognostics aims to enhance market adoption through improved clinical evidence and payer engagement.

Future pipeline products and services

Sera Prognostics is actively developing additional blood-based biomarker tests and predictive analytics products focused on maternal and neonatal health. Future revenue streams are anticipated from these pipeline products as they are brought to market. The company has highlighted the potential for a new test aimed at providing more accurate delivery dates for expectant mothers. The commercialization of these products will depend on successful clinical trials and the establishment of contracts with healthcare providers and payers.

Potential licensing agreements

The company has the potential to enter into licensing agreements for its proprietary technology and tests, which could provide additional revenue streams. In February 2021, Sera entered a commercial collaboration agreement with Elevance Health, which included defined payment structures for the use of the PreTRM test within their network. Sera received $11.2 million related to minimum payments for the year ended December 31, 2023, recorded as deferred revenue. The partnership may lead to further licensing opportunities as more data from clinical studies become available.

Grants and funding for research initiatives

Sera Prognostics has been actively seeking grants and funding to support its research initiatives. The company has historically funded its operations through various means, including the issuance of equity and convertible notes, alongside grants. The company had an accumulated deficit of $271.2 million as of September 30, 2024, indicating a reliance on external funding to support ongoing research and development. In 2024, Sera has a shelf registration statement allowing for the sale of up to $100 million in securities to fund its operations.

Revenue Stream	Details	2024 Revenue (Q3)	2023 Revenue (Q3)
Sales of PreTRM test	Primary source of revenue from the predictive test for preterm birth risk.	$29,000	$42,000
Future pipeline products	Additional tests under development for maternal and neonatal health.	Anticipated revenue from upcoming launches.	Not available yet.
Licensing agreements	Potential collaborations and licensing for proprietary technology.	$11.2 million (from Elevance Health)	Not applicable.
Grants and funding	External funding to support research initiatives and operational costs.	Funding through various means; specifics not disclosed.	Not available yet.

Updated on 16 Nov 2024

Resources:

1. Sera Prognostics, Inc. (SERA) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Sera Prognostics, Inc. (SERA)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Sera Prognostics, Inc. (SERA)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.