Seer, Inc.
Price History
Company Overview
Business Model: SEER, INC.'s mission is to pioneer new methods to decode the biology of the proteome to improve human health. The company's core product, the Proteograph Product Suite (Proteograph), leverages proprietary engineered nanoparticle (NP) technology to provide unbiased, deep, rapid, and large-scale access to the proteome. This integrated solution comprises consumable assays, an automation instrument, and data analysis software, designed to eliminate the historical trade-off between depth and throughput in proteomics. The Proteograph enables peptide-level resolution across proteins in complex samples, facilitating the detection of protein isoforms, post-translational modifications (PTMs), and variant peptides without reliance on predefined binding epitopes. SEER, INC. primarily generates revenue from the sale of the Proteograph Product Suite and related services, targeting proteomics and genomics researchers in academic institutions, biopharmaceutical companies, biobanks, and clinical research organizations.
Market Position: SEER, INC. positions itself as a leader in deep, unbiased proteomics, offering the most complete, precise, and scalable platform for population-scale studies and data-driven biology. The Proteograph Product Suite's performance has been validated in 70 peer-reviewed publications, preprints, and reviews as of December 31, 2025, demonstrating its ability to reveal biologically meaningful signals obscured by affinity-based methods. The company operates in the approximately $30 billion proteomics market (2024 estimate by Frost & Sullivan) and has expanded its Proteograph installed base by over 65% in 2025 compared to 2024, serving more than 190 customers across over 20 countries since its commercial launch in 2021. SEER, INC. emphasizes its unique combination of breadth, depth, accuracy, reproducibility, and scalability, which it believes is unmatched by currently commercially available products.
Recent Strategic Developments: In May 2025, SEER, INC. launched its next-generation Proteograph ONE assay and the SP200 automation instrument, achieving an approximate ten-fold improvement in throughput, enabling processing of over 1,000 samples per week. The Proteograph DIRECT assay was also launched in 2025 for automated direct digestion of samples. The Proteograph Analysis Suite (PAS) received updates in 2025, enhancing data handling, user permissions, and expanding system capacity to support studies involving up to approximately 10,000 samples. Strategic collaborations in 2025 included a 20,000-subject proteomics biomarker discovery program with Korea University and a multi-organ proteomic benchmarking study with Discovery Life Sciences involving over 10,000 samples. The company operationalized a co-marketing and sales agreement with Thermo Fisher Scientific in 2025 and opened its second Seer Technology Access Center (STAC) in Bonn, Germany, in partnership with LIFE & BRAIN GmbH in May 2024. SEER, INC. also made an additional $1.9 million investment in PrognomiQ, Inc.'s Series D Preferred Stock in July 2025, following a $10.0 million investment in August 2024, holding approximately 24% of PrognomiQ, Inc.'s outstanding capital stock as of December 31, 2025. On December 9, 2025, all outstanding Class B common stock automatically converted into Class A common stock.
Geographic Footprint: SEER, INC. serves customers in over 20 countries. Its primary operational regions include North America, the European Union, and the United Kingdom, where it maintains direct sales and customer experience personnel. International channel partners extend its reach to key markets such as China, Australia, Eastern Europe, Israel, Japan, and South Africa. In 2025, 40% of total revenue was generated outside the United States, primarily from countries in Asia and Europe, up from 33% in 2024. The company's corporate headquarters, research and development facilities, and manufacturing and distribution centers are located in Redwood City, California, occupying approximately 51,000 square feet under a lease extending through September 2032.
Financial Performance
Revenue Analysis
| Metric | Current Year (2025) | Prior Year (2024) | Change |
|---|---|---|---|
| Total Revenue | $16.6 million | $14.2 million | +17% |
| Gross Profit | $8.5 million | $7.1 million | +20% |
| Operating Income | ($78.0 million) | ($100.1 million) | +22% |
| Net Income | ($73.6 million) | ($86.6 million) | +15% |
Profitability Metrics:
- Gross Margin: 51.2%
- Operating Margin: -470.0%
- Net Margin: -443.4%
Investment in Growth:
- R&D Expenditure: $43.9 million (264.5% of revenue)
- Capital Expenditures: $1.8 million
- Strategic Investments: $1.9 million in PrognomiQ, Inc. Series D Preferred Stock in 2025.
Business Segment Analysis
SEER, INC. manages its business activities on a consolidated basis and operates in one reportable segment. However, revenue is categorized into Product, Service, Related Party, and Other streams.
Product
Financial Performance:
- Revenue: $11.2 million (+29.0% YoY)
- Cost of Revenue: $5.3 million (+21.2% YoY)
- Operating Margin: 52.7% (Gross Margin)
- Key Growth Drivers: Increased product sales, driven by the launch of the Proteograph ONE assay and SP200 automation instrument, which significantly improved performance and scalability.
Product Portfolio:
- Major product lines: Proteograph Product Suite, consisting of consumables (proprietary engineered nanoparticles and reagents), the SP200 automation instrument, and the Proteograph Analysis Suite (PAS) software.
- New product launches: Proteograph ONE assay (May 2025), SP200 automation instrument (May 2025), and Proteograph DIRECT assay (2025).
Market Dynamics:
- Competitive positioning: Offers unbiased, deep, peptide-level resolution proteomics at scale, generating over 77,000 data measurements per sample. Demonstrated 7.0x expansion in depth of coverage compared to neat plasma.
- Key customer types: Academic institutions, biopharmaceutical companies, biobanks, and clinical research organizations.
- Market trends: Increasing adoption by researchers for population-scale unbiased proteomic studies and integration with genomics for multi-omics approaches.
Service
Financial Performance:
- Revenue: $4.2 million (+40.2% YoY)
- Cost of Revenue: $1.5 million (+4.5% YoY)
- Operating Margin: 64.3% (Gross Margin)
- Key Growth Drivers: Expansion of the Seer Technology Access Center (STAC) service offering, including the opening of a second STAC location in Bonn, Germany.
Product Portfolio:
- Major services: Fee-for-service proteomic data generation and analysis through STAC, leveraging the Proteograph workflow coupled with Thermo Scientific Orbitrap Astral MS.
Market Dynamics:
- Competitive positioning: Aims to lower barriers to access for customers who want to utilize Proteograph data without upfront capital investment.
- Key customer types: Third-party customers accessing proteomic data from their own samples through service facilities and core labs globally.
Related Party
Financial Performance:
- Revenue: $0.8 million (-66.8% YoY)
- Cost of Revenue: $0.2 million (-68.5% YoY)
- Operating Margin: 75.0% (Gross Margin)
- Key Growth Drivers: Primarily from services in 2025, a shift from product sales in 2024.
Product Portfolio:
- Major product lines and services: Sales of products and services to PrognomiQ, Inc., a multiomics diagnostic company spun out of SEER, INC.
Market Dynamics:
- Competitive positioning: PrognomiQ, Inc. leverages the Proteograph Product Suite for diagnostic test development, such as ProVue Lung, a blood-based test for early lung cancer detection launched in November 2025, demonstrating 85% sensitivity and 55% specificity (81% sensitivity for Stage I lung cancer) with a negative predictive value (NPV) of over 99.8%.
Capital Allocation Strategy
Shareholder Returns:
- Share Repurchases: $10.2 million was used to repurchase 5,264,809 shares of Class A common stock in 2025.
- Dividend Payments: SEER, INC. has not declared or paid any cash dividends on its capital stock since inception and does not anticipate paying any in the foreseeable future.
- Future Capital Return Commitments: As of December 31, 2025, $3.1 million remained available under the existing share repurchase authorization. On February 25, 2026, the Board of Directors authorized an additional repurchase of up to $25.0 million of Class A common stock.
Balance Sheet Position:
- Cash and Equivalents: $47.3 million
- Total Debt: No traditional debt instruments disclosed. Operating lease liabilities totaled $23.7 million ($2.6 million current, $21.1 million noncurrent).
- Net Cash Position: $240.6 million (comprising cash, cash equivalents, and investments).
- Credit Rating: Not disclosed.
- Debt Maturity Profile: Operating lease liabilities include $4.0 million in 2027, $4.1 million in 2028, $4.3 million in 2029, $4.4 million in 2030, and $8.1 million thereafter.
Cash Flow Generation:
- Operating Cash Flow: ($44.4 million)
- Free Cash Flow: ($46.2 million) (Operating Cash Flow less Capital Expenditures of $1.8 million)
- Cash Conversion Metrics: Inventory levels increased by $2.9 million, accounts receivable increased by $0.3 million, and accounts payable increased by $1.1 million in 2025.
Operational Excellence
Production & Service Model: SEER, INC. formulates and manufactures its proprietary engineered nanoparticles (NPs) and assembles assay kits at its facilities in Redwood City, California. The company leverages well-established unit operations and procures certain consumable components, including commonly available raw materials, from third-party manufacturers. The SP200 automation instrument is designed by SEER, INC. and its manufacturing is outsourced to Hamilton Company. The company conducts vendor and component qualification for third-party suppliers and performs quality control tests on its NPs. Service delivery is facilitated through the Seer Technology Access Center (STAC), offering fee-for-service proteomic data generation and analysis.
Supply Chain Architecture: Key Suppliers & Partners:
- Automation Instrument Manufacturer: Hamilton Company - a leading manufacturer of automated liquid handling workstations. SEER, INC. has a non-exclusive agreement for manufacturing and supply, renewed through December 2027 with options for two additional one-year renewals. Hamilton Company maintains ISO 9001 and ISO 13485 certifications.
- Reagents & Components: Third-party suppliers for various reagents and components, some of which are single-sourced but readily available from numerous suppliers.
- STAC Partner: LIFE & BRAIN GmbH - partner for the second STAC location in Bonn, Germany.
- Commercial Partner: Thermo Fisher Scientific - co-marketing and sales agreement, including collaboration on marketing activities and joint research.
Facility Network:
- Manufacturing: Redwood City, California (NPs and assay kits).
- Research & Development: Redwood City, California.
- Distribution: Redwood City, California.
- Seer Technology Access Centers: Redwood City, California, and Bonn, Germany.
Operational Metrics:
- Throughput: The Proteograph ONE assay enables parallel processing of up to 80 samples on a single 96-well plate in under five hours. A single Proteograph Product Suite can process over 1,000 samples per week and over 50,000 samples annually.
- Data Density: The Proteograph platform generates over 77,000 data measurements per sample, with an average of approximately 11 peptide-level measurements per protein.
- Depth of Coverage: Proteograph ONE detects approximately 7x more proteins compared to neat plasma on the Orbitrap Astral MS. In a customer study of over 800 samples, approximately 9,000 proteins were identified.
- Reproducibility: Intra-plate and inter-plate coefficient of variation (CV) for protein group intensity were 13.4% and 16.1%, respectively. Peptide data showed intra-plate CV of 17.2% and inter-plate CV of 21%.
Market Access & Customer Relationships
Go-to-Market Strategy: SEER, INC.'s commercial strategy focuses on reducing friction for customers to access Proteograph data. Distribution Channels:
- Direct Sales: Maintained in North America, the United Kingdom, select European Union countries, and the Asia Pacific region, supported by Regional Business Managers, Field Application Scientists, and Field Service Engineers.
- Channel Partners: Expanded geographically to key international markets including China, Australia, Eastern Europe, Israel, Japan, and South Africa.
- Strategic Instrument Placement Program (SIPP): Launched in 2023, this program allows customers to access the Proteograph without upfront capital investment, by loaning the instrument with an upfront purchase of consumable kits and an option to purchase at the end of the loan term.
- Seer Technology Access Center (STAC): Provides fee-for-service access to the Proteograph workflow, with locations in Redwood City, California, and Bonn, Germany (in partnership with LIFE & BRAIN GmbH).
Customer Portfolio: Enterprise Customers:
- Tier 1 Clients: Includes leading academic institutions, biopharmaceutical companies, biobanks, and clinical research organizations.
- Strategic Partnerships: Collaborations with Korea University for a 20,000-subject proteomics biomarker discovery study, and Discovery Life Sciences for a multi-organ proteomic benchmarking study of over 10,000 samples. A co-marketing and sales agreement with Thermo Fisher Scientific was operationalized in 2025.
- Customer Concentration: PrognomiQ, Inc., a related party, accounted for 5% of total revenue in 2025 (down from 17% in 2024). As of December 31, 2025, three customers individually represented 13%, 11%, and 10% of the total accounts receivable balance.
Geographic Revenue Distribution:
- Outside United States: Contributed 40% of total revenue in 2025, an increase from 33% in 2024.
- Growth Markets: Primary international revenue is generated from Asia and Europe.
Competitive Intelligence
Market Structure & Dynamics
Industry Characteristics: The life sciences technology industry is characterized by rapid technological advancements, intense competition, and a strong emphasis on intellectual property. The proteomics market, estimated at approximately $30 billion in 2024, is evolving with a paradigm shift towards data-driven discovery at population scale, increasingly leveraging artificial intelligence (AI) and machine learning. This shift demands high-quality, scalable, and differentiated datasets, particularly at the protein variant level, which is not fully addressed by genomic or transcriptomic measurements alone.
Competitive Positioning Matrix:
| Competitive Factor | Company Position | Key Differentiators |
|---|---|---|
| Technology Leadership | Leading | Pioneered commercial unbiased sample enrichment for MS-based plasma proteomics; proprietary engineered nanoparticle (NP) technology enabling peptide-level resolution; >77,000 data measurements per sample; >1,000 samples per week throughput; demonstrated performance in 70 peer-reviewed publications. |
| Market Share | Competitive | Growing installed base (over 65% increase in 2025 vs. 2024); served over 190 customers across over 20 countries. |
| Cost Position | Advantaged | NP manufacturing process is capital-efficient and labor-efficient, offering high operating leverage potential; integrated solution designed for ease-of-use and efficiency, complementing existing laboratory infrastructure. |
| Customer Relationships | Strong | Collaborations with leading academic institutions, biopharmaceutical companies, biobanks, and clinical research organizations; Strategic Instrument Placement Program (SIPP); Seer Technology Access Center (STAC) services; co-marketing and sales agreement with Thermo Fisher Scientific. |
Direct Competitors
Primary Competitors:
- Established Life Sciences Technology and Diagnostic Companies: Agilent Technologies, Bio-Techne, Bruker, Danaher, DiaSorin, Illumina, and Thermo Fisher Scientific.
- Emerging Growth Companies: Alamar Biosciences, Nautilus Biotechnology, Quanterix, and Quantum-Si.
Emerging Competitive Threats:
- Internal development of assays by large research centers and laboratories.
- New market entrants and disruptive technologies, including those leveraging AI, that could offer competitive products with greater capabilities or lower costs.
Competitive Response Strategy: SEER, INC. aims to expand its addressable market through continuous product innovation, including new applications, workflows, and analysis tools leveraging its proprietary NP and core Proteograph platform. The company focuses on winning additional population-scale cohort programs and driving utilization of its expanding installed base. A key strategic initiative is to establish a leadership position as the preferred proteomic data platform for AI-driven biology, pursuing strategic ecosystem partnerships to generate insights from large, multimodal datasets. Commercial efforts are focused on reducing customer friction through direct sales, STAC services, centers of excellence service providers, international channel partners, and strategic commercial partnerships. The company also protects its sustainable differentiation through a robust intellectual property portfolio covering its technology, automation instrument, and software.
Risk Assessment Framework
Strategic & Market Risks
Market Dynamics: The proteomics market is evolving, and the estimated size and growth of new market opportunities for the Proteograph Product Suite may be smaller or slower than anticipated. Broad scientific and market acceptance is crucial and depends on factors like key opinion leader publications and competitive offerings. Unfavorable U.S. or global economic conditions, including inflation, rising interest rates, government shutdowns, or bank failures, could weaken demand and strain customer budgets. Health epidemics could adversely impact business operations, customer access to laboratories, and R&D spending. The company's reliance on research and development spending by academic and other research institutions, which are subject to external funding fluctuations, poses a risk.
Technology Disruption: The life sciences technology industry is characterized by rapid innovation. Competitors, including large established companies and emerging growth companies, may develop products or technologies, potentially leveraging AI, with greater capabilities or lower costs. Customers may also develop their own in-house solutions, reducing demand for SEER, INC.'s products.
Customer Concentration: Revenue has been concentrated in a relatively small number of customers, including PrognomiQ, Inc. (5% of 2025 revenue). The loss or reduced purchasing by one or more major customers could materially impact financial results. As of December 31, 2025, three customers accounted for 13%, 11%, and 10% of total accounts receivable.
Operational & Execution Risks
Supply Chain Vulnerabilities: SEER, INC. relies on a single contract manufacturer, Hamilton Company, for its automation instruments and on limited or sole suppliers for certain consumable components. Any failure, unsatisfactory performance, or inability to obtain adequate supplies from these suppliers could adversely affect the company's ability to meet demand and supply the Proteograph Product Suite.
Geographic Concentration: Operations and sales in international markets expose the company to various business, regulatory, legal, political, operational, financial, and economic risks, including compliance with foreign regulatory requirements, trade restrictions, and difficulties in enforcing agreements.
Capacity Constraints: The company has limited experience in large-scale production and may face challenges in consistently manufacturing or sourcing its instruments and consumables to necessary specifications or in quantities required to meet demand, especially as it scales commercially. Quality defects or errors in the complex technology (hardware, consumables, software) could lead to increased costs, product recalls, reputational damage, and legal claims.
Financial & Regulatory Risks
Market & Financial Risks: SEER, INC. has a history of significant net losses and negative cash flows from operations, which are expected to continue in the near term. The company may need to raise additional capital, which could result in dilution to stockholders or restrictive debt terms. Investments in early-stage companies, such as PrognomiQ, Inc., are illiquid and subject to fair value adjustments and potential impairment losses.
Regulatory & Compliance Risks: Products are currently labeled "Research Use Only" (RUO). There is a risk that the U.S. Food and Drug Administration (FDA) or other regulatory agencies could determine that SEER, INC.'s products are intended for diagnostic purposes, requiring costly and time-consuming regulatory clearance or approval. The evolving regulatory landscape for Laboratory Developed Tests (LDTs) and in vitro diagnostic products (IVDs), both domestically and internationally (e.g., EU IVDR), could increase compliance costs or decrease demand.
Data Privacy: The company collects, stores, and processes sensitive data, including personally identifiable information. It is subject to evolving international and U.S. federal and state laws and regulations (e.g., GDPR, CCPA, CPRA) relating to data privacy and security. Non-compliance or data security breaches could lead to legal claims, significant penalties, and reputational harm.
Geopolitical & External Risks
Geopolitical Exposure: International business activities are subject to risks such as changing foreign regulatory requirements, trade restrictions (e.g., U.S.-China trade policies), and difficulties in protecting intellectual property rights in foreign jurisdictions. These factors could require significant resources to remedy or adversely affect financial results.
Trade Relations: Ongoing uncertainty regarding trade policies, tariffs, and exchange controls, particularly between the United States and China, could impact the company's ability to obtain or use services from existing providers or export/sell products.
Sanctions & Export Controls: Compliance with U.S. laws (e.g., FCPA, Office of Foreign Asset Control) and foreign regulations (e.g., data protection laws in Europe and China) is required for international operations.
Innovation & Technology Leadership
Research & Development Focus: SEER, INC.'s R&D efforts are centered on its proprietary engineered nanoparticle (NP) technology, which forms the core of the Proteograph Product Suite. The company continuously innovates to develop new products, applications, workflows, and analysis tools, aiming to create value across the R&D value chain from discovery to clinical research. Key areas include enhancing proteomic assays (e.g., Proteograph ONE, Proteograph DIRECT), improving automation instruments (SP200), and advancing data analysis software (Proteograph Analysis Suite - PAS) to support AI-driven scientific discovery. SEER, INC. utilizes machine-learning techniques and large-scale analyses to understand the relationships between NP surfaces and protein binding, informing the design of future products.
Intellectual Property Portfolio:
- Patent Strategy: As of December 31, 2025, SEER, INC. owned or exclusively licensed over 230 issued patents and patent applications worldwide, covering proteomic assays, nanoparticle chemistry, data analysis, and automation instruments. These patents are expected to expire between 2023 and 2045.
- Licensing Programs: The company exclusively licenses U.S. and ex-U.S. patents and patent applications from The Brigham and Women’s Hospital (BWH) related to methods for identifying biological states using nanoparticle and biosensor compositions, with these in-licensed patents expected to expire between 2034 and 2037. SEER, INC. has also non-exclusively licensed certain of its patents and sublicensed BWH-licensed patents to PrognomiQ, Inc. for human diagnostics.
- IP Litigation: The company is currently involved in an Inter Partes Review before the USPTO, challenging the validity of select claims of U.S. Patent No. 11,435,360, which is exclusively licensed from BWH. Additionally, nullity actions and oppositions have been filed in Germany against other BWH-licensed European patents and utility models. A prior lawsuit challenging inventorship was dismissed with prejudice in October 2024.
Technology Partnerships:
- Strategic Alliances: SEER, INC. has a co-marketing and sales agreement with Thermo Fisher Scientific, which also involves collaboration on marketing activities and joint research and population-scale studies.
- Research Collaborations: Engaged in population-scale studies with institutions like Korea University and Discovery Life Sciences.
- PrognomiQ, Inc.: A multiomics diagnostic company spun out of SEER, INC., leveraging the Proteograph solution for diagnostic test development.
Leadership & Governance
Executive Leadership Team
| Position | Executive | Tenure | Prior Experience |
|---|---|---|---|
| Chief Executive Officer | Omid Farokhzad, M.D. | Since 2017 | Founder of SEER, INC. |
| President and Chief Financial Officer | David Horn | Not specified | Critical to vision, strategic direction, product development, and commercialization efforts. |
| VP of Information Technology | Not named | Not specified | Over 20 years of experience managing global IT operations, including strategy, information security, applications, infrastructure, support, and execution. |
Leadership Continuity: The senior management team, including Omid Farokhzad and David Horn, is considered critical to the company's strategic direction and commercialization efforts. However, SEER, INC. does not maintain fixed-term employment contracts with its employees. The company has previously announced reductions in force and may incur additional costs or face challenges in pursuing new opportunities due to insufficient personnel.
Board Composition: The Board of Directors oversees cybersecurity risk, delegating this function to the Audit Committee. The Audit Committee receives regular reports from the VP of Information Technology and oversees management's cybersecurity risk management program. Isaac Ro was appointed to the Audit Committee on September 2, 2025, and was determined to qualify as an "audit committee financial expert." Nicolas Roelofs, Ph.D., serves as the Lead Independent Director.
Human Capital Strategy
Workforce Composition:
- Total Employees: 124 employees as of December 31, 2025.
- Geographic Distribution: Employees are based in North America, the European Union, and the United Kingdom.
- Skill Mix: Many employees hold masters and doctorate degrees, indicating a highly educated workforce.
Talent Management: Acquisition & Retention:
- Hiring Strategy: Objectives include identifying, recruiting, retaining, incentivizing, and integrating existing and new employees, advisors, and consultants. The company aims to attract highly-trained sales personnel with scientific backgrounds.
- Retention Metrics: Not explicitly disclosed, but competition for qualified personnel is intense, particularly in the San Francisco Bay Area.
- Employee Value Proposition: Equity and cash incentive plans are used to attract, retain, and reward personnel, aligning with increasing stockholder value.
Diversity & Development:
- Diversity Metrics: Not explicitly disclosed.
- Development Programs: Not explicitly disclosed.
- Culture & Engagement: Guided by core values: Better Together, Customer Centric, Difference Makers, People First, and Trailblazers, which set the foundation for business conduct and employee interaction.
Environmental & Social Impact
Environmental Commitments: Not explicitly detailed in the filing. However, the company acknowledges risks related to compliance with environmental health and safety regulations, including those concerning the collection, reuse, and recycling of waste from manufactured products.
Supply Chain Sustainability: Not explicitly detailed in the filing. The company's risk factors mention regulations relating to the use of certain hazardous substances or chemicals in commercial products and the collection, reuse, and recycling of waste from manufactured products.
Social Impact Initiatives: Not explicitly detailed in the filing. The company's risk factors mention the importance of responsible corporate citizenship, support for local communities, employee diversity, and human capital management.
Business Cyclicality & Seasonality
Demand Patterns:
- Seasonal Trends: The company's operating results may fluctuate due to seasonal spending patterns and differences in budgetary cycles, especially for government- or grant-funded customers whose cycles often coincide with government fiscal year ends.
- Economic Sensitivity: Demand for the Proteograph Product Suite and related services is dependent on the research and development budgets of customers, which are impacted by macroeconomic conditions, government funding levels, and strategic shifts by commercial companies.
- Industry Cycles: The market for proteomics and genomics technologies is evolving, and the adoption of new life sciences technology may take time to develop and mature.
Planning & Forecasting: Not explicitly detailed in the filing.
Regulatory Environment & Compliance
Regulatory Framework: Industry-Specific Regulations:
- Medical Devices: SEER, INC.'s products are labeled and sold for "Research Use Only" (RUO) and are not currently subject to U.S. Food and Drug Administration (FDA) medical device regulation. However, if the company elects to market products for clinical diagnostic use, or if the FDA determines RUO products are being used for diagnostic purposes, they would require 510(k) clearance or premarket approval, which is expensive, time-consuming, and uncertain. In January 2024, the FDA announced plans to reclassify certain high-risk in vitro diagnostics as Class II devices.
- Laboratory Developed Tests (LDTs): The FDA's historical enforcement discretion for LDTs is changing. A May 2024 final rule to regulate LDTs was vacated by a Texas district court in March 2025, creating ongoing uncertainty regarding future regulation.
- International Compliance: International sales are subject to foreign government regulations, which vary significantly. In Europe, products would be subject to the IVD Medical Device Regulation (IVDR) EU 2017/746, which became applicable in May 2022 and has proposals for amendments in 2025.
- Quality Management System Regulation (QMSR): Effective February 2, 2026, replacing the Quality System Regulation, and incorporating ISO 13485:2016.
Trade & Export Controls:
- Export Restrictions: Compliance with U.S. laws such as the U.S. Foreign Corrupt Practices Act (FCPA) and Office of Foreign Asset Control (OFAC) sanctions, as well as foreign data protection laws (e.g., in Europe and China), is required for international business.
- Sanctions Compliance: Restrictions on cross-border investment and trade relations, particularly with countries like China, could materially and adversely affect business.
Legal Proceedings: SEER, INC. is not currently a party to any material legal proceedings. However, it is involved in several intellectual property challenges:
- Inter Partes Review: On October 7, 2024, PreOmics GmbH and Biognosys AG filed a petition for Inter Partes Review before the USPTO (Case No. IPR2024-01473), challenging the validity of select claims of U.S. Patent No. 11,435,360, exclusively licensed from The Brigham and Women’s Hospital (BWH). The Patent Trial and Appeal Board (PTAB) instituted review of certain claims on April 17, 2025.
- Nullity Actions/Cancellation Requests: In Germany, an anonymous third party initiated a nullity action against European Patent EP3554681 and a cancellation request against Utility Model No. 202017007363 (both exclusively licensed from BWH) on November 18, 2024, and January 13, 2025, respectively.
- Opposition Proceedings: On May 27, 2025, an anonymous third party filed an Opposition to European Patent 4,056,263 (exclusively licensed from BWH).
- Prior Litigation: A lawsuit filed by Giulio Caracciolo and Dipartimento di Medicina Molecolare Sapienza Universita di Roma challenging inventorship on certain BWH-licensed patents was dismissed with prejudice on October 25, 2024.
Tax Strategy & Considerations
Tax Profile:
- Effective Tax Rate: The effective tax rate was -0.3% in 2025 and -0.1% in 2024, primarily due to net losses and a full valuation allowance on domestic deferred tax assets.
- Geographic Tax Planning: Income tax expense is primarily attributable to wholly-owned foreign subsidiaries.
- Tax Reform Impact: The One Big Beautiful Bill Act (OBBBA), enacted July 4, 2025, made 100% bonus depreciation and immediate deduction of domestic research and development costs permanent. Due to the company's valuation allowance position, the OBBBA did not have a material impact on the effective tax rate or cash flow in 2025.
- Net Operating Losses (NOLs): As of December 31, 2025, federal NOL carryforwards were $262.4 million (carryforward indefinitely) and state NOL carryforwards were $226.6 million (begin to expire in 2035). While ownership changes occurred in 2018, 2020, and 2022, no tax attributes are expected to expire unutilized due to Section 382 limitations. California legislation limits the use of state NOLs for tax years 2024-2026.
- Research and Development Credits: Federal R&D credit carryforwards were $8.6 million (begin to expire in 2039) and state R&D credit carryforwards were $6.8 million (carry forward indefinitely) as of December 31, 2025.
- Unrecognized Tax Benefits: Totaled $3.8 million as of December 31, 2025, with no significant change expected over the next twelve months.
Insurance & Risk Transfer
Risk Management Framework:
- Insurance Coverage: SEER, INC. maintains insurance for property damage and business disruption, and self-insures for earthquake risk. However, this insurance may not be sufficient to cover all potential losses and may not be available on acceptable terms in the future.
- Risk Transfer Mechanisms: Not explicitly detailed beyond insurance. The company enters into agreements with general indemnification provisions in the normal course of business, but its exposure under these is unknown. Indemnification agreements are in place with certain directors and officers.