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What changed in BIODESIX INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of BIODESIX INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+444 added−524 removedSource: 10-K (2026-02-26) vs 10-K (2025-03-03)

Top changes in BIODESIX INC's 2025 10-K

444 paragraphs added · 524 removed · 358 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

127 edited+27 added−53 removed219 unchanged
Biggest changeDuring 2024, we achieved multiple milestones: • We delivered on our commercial and diagnostic services strengths resulting in an estimated $71.3 million in total revenue for the year, an increase of 45% over 2023; o Lung Diagnostic Testing - $64.7 million of revenue, an increase of 43%, from 54,300 tests delivered, an increase of 40%; o Development Services - $6.6 million in biopharmaceutical services revenue, an increase of 70%; • We continued to present and publish new clinical data supporting the adoption of our tests, increased reimbursement coverage for our Lung Diagnostic tests from private payors, and launched new research partnerships, including with the Memorial Sloan Kettering Cancer Center; • We launched the new CLARIFY study, which will collect patient outcomes and other clinical information on 4,000 patients who have received Nodify Lung® Nodule Risk Assessment testing in the clinical setting and have at least 1-2 years of follow-up. • We improved our operational efficiencies increasing gross margin percentage to 78% as compared to 73% in 2023; • We maintained our cost-disciplined approach limiting growth in full year Operating Expense, excluding Direct costs and expenses to 17% over 2023, including non-cash share-based compensation expenses, while growing revenue by 45%; and • We were awarded the prestigious 2024 Inc.
Biggest changeDuring 2025, we achieved numerous company milestones: • We delivered on our commercial and diagnostic services strengths resulting in an estimated $88.5 million in total revenue for the year, an increase of 24% over 2024; o Lung Diagnostic Testing - $79.2 million of revenue, an increase of 22%, from 62,600 tests delivered, an increase of 15%; o Development Services - $9.3 million in biopharmaceutical services revenue, an increase of 41%; • We continued to present and publish new clinical data supporting the adoption of our tests, increased reimbursement coverage for our Lung Diagnostic tests from private payors, and advanced our research and development partnerships; • We enrolled more than 1,500 patients in the CLARIFY study, which will collect patient outcomes and other clinical information on 4,000 patients who have received Nodify Lung® Nodule Risk Assessment testing in the clinical setting and have at least 1-2 years of follow-up. • We improved our operational efficiencies increasing gross margin percentage to 81% as compared to 78% in 2024; • We maintained our cost-disciplined approach limiting growth in full year Operating Expense, excluding Direct costs and expenses to 10% over 2024, including non-cash share-based compensation expenses, while growing revenue by 24%; and • We were awarded the prestigious 2025 Denver Post | Energage Top Workplaces, the second consecutive year receiving an employee-survey based recognition award – a reflection of our strong team culture and employee engagement.
There have also been recent advances in the use of targeted therapies in early-stage lung disease. These therapies typically target 4 specific genomic mutations or alterations found in some tumors.
There 4 have also been recent advances in the use of targeted therapies in early-stage lung disease. These therapies typically target specific genomic mutations or alterations found in some tumors.
Clinical data is sometimes required to support substantial equivalence. If a manufacturer obtains a 510(k) clearance for its device and then makes a modification that could significantly affect the device’s safety or effectiveness or constitutes a major change or modification in the intended use of the device, a new clearance, authorization or approval may be required.
Clinical data is sometimes required to support substantial equivalence. If a manufacturer obtains a 510(k) clearance for its device and then makes a modification that could significantly affect the device’s safety or effectiveness or constitutes a major change or modification in the intended use of the device, then a new clearance, authorization or approval may be required.
FDA’s goal is to review a De Novo request within 150 review days after receiving the petition. As with a 510(k) submission or PMA, the length of the review can be prolonged if the FDA requests additional information from the applicant.
The FDA’s goal is to review a De Novo request within 150 review days after receiving the petition. As with a 510(k) submission or PMA, the length of the review can be prolonged if the FDA requests additional information from the applicant.
Government regulations specific to medical devices are wide ranging and govern, among other things: • product design, development, manufacturing assembly and release; • laboratory and clinical testing, labeling, packaging, storage and distribution; • product safety and efficacy; • premarketing clearance or approval; • service operations, including assay development and validation, clinical sample testing, clinical trial solutions, and quality and regulatory solutions; • record keeping; • product marketing, promotion and advertising, sales and distribution; • post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals; 14 • post-market approval studies; and • product import and export Many countries in which we may offer any of our diagnostic tests in the future have anti-kickback regulations prohibiting providers from offering, paying, soliciting or receiving remuneration, directly or indirectly, in order to induce business that is reimbursable under any national health care program.
Government regulations specific to medical devices are wide ranging and govern, among other things: • product design, development, manufacturing assembly and release; • laboratory and clinical testing, labeling, packaging, storage and distribution; • product safety and efficacy; • premarketing clearance or approval; • service operations, including assay development and validation, clinical sample testing, clinical trial solutions, and quality and regulatory solutions; • record keeping; • product marketing, promotion and advertising, sales and distribution; • post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals; • post-market approval studies; and • product import and export Many countries in which we may offer any of our diagnostic tests in the future have anti-kickback regulations prohibiting providers from offering, paying, soliciting or receiving remuneration, directly or indirectly, in order to induce business that is reimbursable under any national health care program.
For example, in the European Economic Area (EEA), a medical device must meet the Medical Devices Directive’s (MDD)/In Vitro Medical Devices Directive’s (IVDD) Essential Requirements or, applicable on May 26, 2021, the Medical Devices Regulation’s (MDR) / applicable on May 26, 2022, In Vitro Medical Devices Regulation’s (IVDR) General Safety and Performance Requirements which apply to it, taking into account its intended purpose as defined by the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.
For example, in the European Economic Area (EEA), a medical device must meet the Medical Devices 15 Directive’s (MDD)/In Vitro Medical Devices Directive’s (IVDD) Essential Requirements or, applicable on May 26, 2021, the Medical Devices Regulation’s (MDR) / applicable on May 26, 2022, In Vitro Medical Devices Regulation’s (IVDR) General Safety and Performance Requirements which apply to it, taking into account its intended purpose as defined by the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.
Premarket Submission Process Unless a statutory or regulatory exemption or enforcement discretion policy applies, before a new medical device, or a new intended use of, claim for, or significant modification to an existing device, can be marketed in the United States, the manufacturer must obtain the FDA’s: (1) permission for commercial distribution under section 510(k) of the FDCA (510(k) clearance); or (2) approval of a Premarket Approval (PMA); or (3) de novo classification and authorization.
Premarket Submission Process Unless a statutory or regulatory exemption or enforcement discretion policy applies, before a new medical device, or a new intended use of, claim for, or significant modification to an existing device, can be marketed in the United States, the manufacturer must obtain the FDA’s: (1) permission for commercial distribution under section 510(k) of the FDCA (510(k) clearance); or (2) approval of a Premarket Approval Application (PMA); or (3) De Novo classification and authorization.
Reimbursement for laboratory tests in the United States is determined by various payers, including private third-party payers, managed care organizations, and state and federal health care programs, such as Medicare and Medicaid. In Medicare, coverage of an item or service depends on whether it is “reasonable and necessary” under Section 8 1862(a)(1)(A) of the Social Security Act (SSA).
Reimbursement for laboratory tests in the United States is determined by various payers, including private third-party payers, managed care organizations, and state and federal health care programs, such as Medicare and Medicaid. In Medicare, coverage of an item or service depends on whether it is “reasonable and necessary” under Section 1862(a)(1)(A) of the Social Security Act (SSA).
In addition to these federal laws, there are often similar state anti-kickback and false claims laws that typically apply to arrangements involving reimbursement by a state-funded Medicaid or other health care program. Often, these laws closely follow the language of 18 their federal law counterparts, although they do not always have the same exceptions or safe harbors.
In addition to these federal laws, there are often similar state anti-kickback and false claims laws that typically apply to arrangements involving reimbursement by a state-funded Medicaid or other health care program. Often, these laws closely follow the language of their federal law counterparts, although they do not always have the same exceptions or safe harbors.
Lung Diagnostic Tests - Drive increased awareness, adoption, and reimbursement coverage of our diagnostic tests by: • continuously educating health care providers key opinion leaders, hospital systems, advocacy groups, patients, payers, academic research organizations, and technology assessment and guideline organizations on the clinical data and benefits of our tests; • continuing to invest in the expansion and professional development of our lung-focused clinical sales force and commercial support teams; • extending our commercial reach in clinics specializing in the management of lung nodules and the diagnosis of lung disease and their referral networks; • investing in clinical studies and publish additional clinical data to continue to increase market adoption and reimbursement coverage for our tests; 3 • publishing health economics and outcomes research demonstrating the impact of our tests on the US healthcare system and overall costs; and • engaging key opinion leaders and partners to identify existing or emerging clinical needs in lung disease and to develop tests to address those questions to be provided to the market through our existing commercial channel. 2.
Lung Diagnostic Tests - Drive increased awareness, adoption, and reimbursement coverage of our diagnostic tests by: • continuously educating healthcare providers key opinion leaders, hospital systems, advocacy groups, patients, payers, academic research organizations, and technology assessment and guideline organizations on the clinical data and benefits of our tests; • continuing to invest in the expansion and professional development of our lung-focused clinical sales force and commercial support teams; • extending our commercial reach in clinics specializing in the management of lung nodules and the diagnosis of lung disease and their primary care referral networks; • investing in clinical studies and publish additional clinical data to continue to increase market adoption and reimbursement coverage for our tests; 3 • publishing health economics and outcomes research demonstrating the impact of our tests on the US healthcare system and decreasing overall costs; and • engaging key opinion leaders and partners to identify existing or emerging clinical needs in lung disease and to develop tests to address those questions to be provided to the market through our existing commercial channel. 2.
We may also be subject to laws and regulations in foreign countries covering data privacy and other protection of health and employee information that may add additional compliance burden and complexity. For example, in the EEA, the collection and use of personal data is governed by the European Union's General Data Protection Regulation (GDPR).
We may also be subject to laws and regulations in foreign countries covering data privacy and other protection of health and employee information that may add additional compliance burden and complexity. For example, in the EEA, the collection and use of personal 20 data is governed by the European Union's General Data Protection Regulation (GDPR).
We have built one of the only commercial teams in diagnostics focused on lung. By offering a broad menu of tests for current clinical use, and continuing to develop additional tests for lung, we can efficiently leverage the existing team and infrastructure to address more clinical needs for the same call point.
We have built one of the only commercial teams in diagnostics focused on lung disease. By offering a broad menu of tests for current clinical use, and continuing to develop additional tests for lung, we can efficiently leverage the existing team and infrastructure to address more clinical needs for the same call point.
Compliance with environmental laws and regulations has not had a material effect on our capital expenditures, earning or competitive position. To date, there has not been a for cause OSHA or EPA inspection. Corporate Information We were incorporated in Delaware in 2005 as Elston Technologies, Inc.
Compliance with environmental laws and regulations has not had a material effect on our capital expenditures, earning or competitive position. To date, there has not been a for cause OSHA or EPA inspection. 21 Corporate Information We were incorporated in Delaware in 2005 as Elston Technologies, Inc.
Our Louisville, Colorado and De Soto, Kansas laboratories are certified and adhere to the NYS CLEP, based on New York State Public Health Law, Article 5 Title 5. NYS CLEP is exempt from CLIA and establishes their own method of laboratory certification and test validation approval.
Our Louisville, Colorado and De Soto, Kansas laboratories are certified and adhere to the NYS CLEP, based on New York State Public Health Law, Article 5 Title 5. NYS CLEP is exempt from CLIA and establishes their own method of laboratory certification and test 14 validation approval.
While it supports contemporaneous marketing authorizations, if there are any deficiencies in the submissions, the FDA may place a PMA review of a CDx on hold or request additional testing, which could potentially delay the approval of the corresponding new drug application or the marketing authorization of the CDx, or otherwise complicate the review process.
While the FDA supports contemporaneous marketing authorizations, if there are any deficiencies in the submissions, the FDA may place a PMA review of a CDx on hold or request additional testing, which could potentially delay the approval of the corresponding new drug application or the marketing authorization of the CDx, or otherwise complicate the review process.
Diagnostic Development Services — Expand revenue-generating contracts with research institutions, biopharmaceutical clients, and life sciences customers by: • leveraging our team’s expertise and multi-omic offering to sell a comprehensive line of research, discovery, development, clinical trial testing, regulatory, reimbursement, commercialization, and logistics support services across cancer types and diseases; • adding new biopharmaceutical, life science, tools, and diagnostic customers and leveraging existing projects and relationships to expand sales with our current customers; • engaging with our customers, key opinion leaders, leading academic centers, and scientific experts to stay ahead of the rapidly evolving diagnostic and therapeutic landscape and to identify unmet clinical needs; and • entering strategic partnerships with biopharmaceutical companies, academic research organizations, technology providers, and other diagnostic companies.
Development Services — Expand revenue-generating contracts with research institutions, biopharmaceutical clients, and life sciences customers by: • leveraging our team’s expertise and multi-omic offering to sell a comprehensive line of research, discovery, development, clinical trial testing, regulatory, reimbursement, commercialization, and logistics support services across cancer types and diseases; • adding new biopharmaceutical, life science, tools, and diagnostic customers and leveraging existing projects and relationships to expand engagement with our current customers; • engaging with our customers, key opinion leaders, leading academic centers, and scientific experts to stay ahead of the rapidly evolving diagnostic and therapeutic landscape and to identify unmet clinical needs; and • entering strategic partnerships with biopharmaceutical companies, academic research organizations, technology providers, and other diagnostic companies.
We may not receive an extension if we fail 11 to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request.
We may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request.
Available Information We file with, or furnish to, the SEC reports including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended.
Available Information We file with, or furnish to, the Securities and Exchange Commission (SEC) reports including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended.
However, most Laboratory Developed Tests (LDTs) are not currently subject to enforcement under the FDA’s regulation (although reagents, instruments, software or components provided by third parties and used to perform LDTs may be subject to such enforcement) because the FDA has historically exercised enforcement discretion over LDTs.
However, most Laboratory Developed Tests (LDTs) are not currently subject to enforcement under the FDA’s regulation (although reagents, instruments, software or components provided by third parties and used to perform LDTs may be subject to such enforcement), and the FDA has historically exercised enforcement discretion over LDTs.
These processes can be resource intensive, expensive, and lengthy, and require payment of significant user fees. Under the 510(k)-clearance process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the device is “substantially equivalent” to a legally marketed predicate device.
These processes can be resource intensive, expensive, and lengthy, and require payment of significant user fees. 16 Under the 510(k) clearance process, the manufacturer must submit to the FDA a premarket notification, demonstrating that the device is “substantially equivalent” to a legally marketed predicate device.
While we take steps to protect our 20 systems and data, security incidents, data breaches, computer malware and computer hacking attacks have become more prevalent across industries, including the life sciences sector, and may occur on our systems or those of our third-party service providers.
While we take steps to protect our systems and data, security incidents, data breaches, computer malware and computer hacking attacks have become more prevalent across industries, including the life sciences sector, and may occur on our systems or those of our third-party service providers.
We are committed to fostering a diverse and inclusive workplace that attracts and retains exceptional talent offering opportunities for our team members to 22 grow and develop in their careers, supported by a competitive suite of benefits and health and wellness programs.
We are committed to fostering a diverse and inclusive workplace that attracts and retains exceptional talent offering opportunities for our team members to grow and develop in their careers, supported by a competitive suite of benefits and health and wellness programs.
There is substantial interest and activity in tumor profiling through liquid biopsy. Our genomic test offerings, the GeneStrat ddPCR and GeneStrat NGS tests, face competition from academic hospital laboratories, and companies such as Guardant Health and 9 Foundation Medicine.
There is substantial interest and activity in tumor profiling through liquid biopsy. Our genomic test offerings, the GeneStrat ddPCR and GeneStrat NGS tests, face competition from academic hospital laboratories, and companies such as Guardant Health and Foundation Medicine.
With our international operations through our third-party partnerships, we could incur significant fines and penalties, as well as criminal liability, if we fail to comply with either the anti-bribery or accounting requirements of the FCPA, or similar international bribery laws.
With our international operations through our third-party partnerships, we could incur significant fines and penalties, as well as criminal liability, if we fail to comply with either the anti-bribery or accounting requirements of the FCPA, or 19 similar international bribery laws.
We derive our revenue from two sources: (i) Biodesix Lung Diagnostic Testing (Lung Diagnostic Testing), providing lung diagnostic testing services for healthcare providers associated with our five blood-based tests and (ii) Biodesix Development Services (Development Services) providing diagnostic testing services to biopharmaceutical, life sciences, and diagnostic companies.
We derive our revenue from two sources: (i) Biodesix Lung Diagnostic Testing (Lung Diagnostic Testing), providing lung diagnostic testing services for healthcare providers associated with our five blood-based tests and (ii) Biodesix Development Services (Development Services) providing diagnostic testing services and consulting to biopharmaceutical, life sciences, and diagnostic companies.
Accordingly, a PMA typically includes, but is not limited to, extensive technical information regarding device design and development, pre-clinical and clinical trial data, manufacturing information, labeling, 16 and financial disclosure information for the clinical investigators in device studies.
Accordingly, a PMA typically includes, but is not limited to, extensive technical information regarding device design and development, pre-clinical and clinical trial data, manufacturing information, labeling, and financial disclosure information for the clinical investigators in device studies.
If the FDA were to begin enforcement with respect to our LDTs, we could incur substantial costs and 12 delays associated with trying to obtain pre-market clearance or approval and costs associated with complying with post-market requirements.
If the FDA were to begin enforcement with respect to our LDTs, we could incur substantial costs and delays associated with trying to obtain pre-market clearance or approval and costs associated with complying with post-market requirements.
We own patents and patent applications as well as trade secrets relating to our products 10 currently in development, a collection device for whole blood, our business strategy, client lists and business methods.
We own patents and patent applications as well as trade secrets relating to our products currently in development, a collection device for whole blood, our business strategy, client lists and business methods.
While our biopharmaceutical discovery, diagnostic development and testing revenue continues to grow, it is important to note that we benefit greatly from these partnerships in many ways that expand beyond revenue.
While our biopharmaceutical discovery, diagnostic development and testing revenue continues to grow, it is important to note that we benefit greatly from these partnerships in many ways beyond revenue.
The information provided on our website (or any other website referred to in this report) is not part of this report and is not incorporated by reference as part of this Annual Report on Form 10-K. 23
The information provided on our website (or any other website referred to in this report) is not part of this report and is not incorporated by reference as part of this Annual Report on Form 10-K.
As a condition of PMA application approval, the FDA may also require some form of post-approval study or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer-term safety and effectiveness data for the device.
As a condition of PMA approval, the FDA may also require some form of post-approval study or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer-term safety and 17 effectiveness data for the device.
We believe that establishing a new standard of care utilizing personalized diagnostics requires a deep understanding of clinical needs, scientific expertise to develop tests using the optimal technology for each clinical question, development of clinical evidence to demonstrate benefits of the testing, a scalable operational infrastructure, and an established commercial channel to drive market adoption and payer coverage.
We believe that establishing a new standard of care utilizing personalized diagnostics requires an extensive understanding of clinical needs, scientific expertise to develop tests using the optimal technology for each clinical question, development of clinical evidence to demonstrate benefits of the testing, a scalable operational infrastructure, and an established commercial channel to drive market adoption and payer coverage.
In addition, we may be subject to state privacy, cybersecurity, and data breach notification laws, which may govern the collection, use, disclosure and protection of health-related and other personal information. California, for example, has enacted the Confidentiality of Medical Information Act, which, in addition to HIPAA and HITECH, sets forth standards with which all California health care providers must abide.
In addition, we may be subject to state privacy, cybersecurity, and data breach notification laws, which may govern the collection, use, disclosure and protection of health-related and other personal information. California, for example, has enacted the Confidentiality of Medical Information Act, which, in addition to HIPAA and HITECH, sets forth standards with which regulated California health care providers must abide.
Conversely, in the immune profiling market, we believe Adaptive Biotechnologies and Personalis are our most significant competitors. Clinical Laboratory Operations Throughout 2024, all aspects of the testing process, from receipt of the test requisition form through delivery of test results, were performed for the VeriStrat, GeneStrat ddPCR, and GeneStrat NGS tests in our Louisville, Colorado facility.
Conversely, in the immune profiling market, we believe Adaptive Biotechnologies and Personalis are our most significant competitors. Clinical Laboratory Operations Throughout 2025, all aspects of the testing process, from receipt of the test requisition form through delivery of test results, were performed for the VeriStrat, GeneStrat ddPCR, and GeneStrat NGS tests in our Louisville, Colorado facility.
The proprietary testing methods use semi-automated workflows that facilitate the successful delivery averaging 90% of our tests within five days, and we believe our existing workflows will continue to successfully deliver our tests within this timeframe. Our De Soto, Kansas facility is a high-complexity CLIA certified clinical laboratory.
The proprietary testing methods use semi-automated workflows that facilitate successful delivery averaging 90% of our tests within five business days, and we believe our existing workflows will continue to successfully deliver our tests within this timeframe. Our De Soto, Kansas facility is a high-complexity CLIA 10 certified clinical laboratory.
Moreover, data security incidents or data breaches, as well as attacks on our IT systems, could result in operational disruptions or data loss or corruption that could adversely impact our business and operations, resulting in substantial investment of resources to investigate, recover and remediate and subject us to heightened regulatory scrutiny. See Item 1C.
Moreover, data cybersecurity incidents or data breaches, as well as attacks on our IT systems, could result in operational disruptions or data loss or corruption that could adversely impact our business and operations, resulting in substantial investment of resources to investigate, recover and remediate and subject us to heightened regulatory scrutiny. See Item 1C.
The proprietary testing methods use semi-automated workflows that facilitate the successful delivery averaging 90% of our tests within three days, and we believe our existing workflows will continue to successfully deliver our tests within this timeframe. Our Louisville facility is a high-complexity CLIA certified clinical laboratory.
The proprietary testing methods use semi-automated workflows that facilitate successful delivery averaging 90% of our tests within three days, and we believe our existing workflows will continue to successfully deliver our tests within this timeframe. Our Louisville facility is a high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified clinical laboratory.
HIPAA is enforced by the Department of Health and Human Services, Office for Civil Rights, and HIPAA also authorizes state attorneys general to file suit on behalf of their residents for violations. Courts are able to award damages, costs and attorneys’ fees related to violations of HIPAA in such cases.
HIPAA is enforced by the Department of Health and Human Services, Office for Civil Rights (HHS OCR), and HIPAA also authorizes state attorneys general to file suit on behalf of their residents for violations. Courts are able to award damages, costs and attorneys’ fees related to violations of HIPAA in such cases.
Our diagnostic tests provide rapid and actionable diagnostic information to help inform physicians on the next steps in a patient’s care plan to help diagnose lung cancer faster and expediting time to treatment. • Our broad test offering and continued development and publication of clinical data supports market adoption.
Our diagnostic tests provide rapid and actionable diagnostic information to help inform physicians on the next steps in a patient’s care plan to help diagnose lung cancer faster and expediting time to treatment. • Our broad test offering and continued development and publication of clinical data drives market adoption.
Biodesix Diagnostic Services has been utilized by over 65 industry clients and academic research partners. We continuously revisit our technology strategy and roadmap to integrate new technologies into our evolving offering, which ultimately support the addition of new service and product revenue offerings.
Biodesix Development Services has been utilized by over 65 industry clients and academic research partners. We continuously revisit our technology strategy and roadmap to integrate new technologies into our evolving offering, which ultimately support the addition of new service and product revenue offerings.
A disruption to this supply would negatively impact our ability to perform the GeneStrat tests until alternatives could be validated. All materials for our VeriStrat test and Nodify XL2 test have alternative suppliers readily available, and a disruption in any single supplier would not materially impact our ability to deliver the test.
A disruption to this supply would negatively impact our ability to perform the GeneStrat tests until alternatives can be validated. All materials for our VeriStrat test and Nodify XL2 test have alternative suppliers readily available, and a disruption in any single supplier would not materially impact our ability to deliver the test.
Under HIPAA and HITECH, the Department of HHS issues regulations that establish uniform standards governing the conduct of certain electronic healthcare transactions and requirements for protecting the privacy and security of PHI, used or disclosed by CEs and their authorized business associates (BAs).
Under HIPAA and HITECH, the Department of HHS issues regulations that establish uniform standards governing the conduct of certain electronic healthcare transactions and requirements for protecting the privacy and security of PHI, used or disclosed by covered entities (CEs) and their authorized business associates (BAs).
The Nodify CDT test is validated for use in patients who are 40 years or older, have no history of cancer except non-melanomatous skin cancer, have nodules between 8 and 30mm, and pre-test risk of lung cancer of less than 65%.
The Nodify CDT test is validated for use in patients who are 40 years or older, have no history of cancer except non-melanomatous skin cancer, have nodules between 4 and 30mm, and pre-test risk of lung cancer of less than 65%.
For some of the tests we conduct, there may not be a specific CPT or HCPCS code, in which case the test may be billed under a miscellaneous code for an unlisted molecular pathology procedure or unlisted multiple anolyte test with algorithmic analysis (MAAA) procedure.
For some of the tests we conduct, there may not be a specific CPT or HCPCS code, in which case the test may be billed under a miscellaneous code for an unlisted molecular pathology procedure or unlisted multiple analyte test with algorithmic analysis (MAAA) procedure.
If we do not timely file any non-provisional patent applications, we will lose our priority date and any patent protection on the inventions disclosed in any such provisional patent application. As of December 31, 2024, we have no pending PCT applications.
If we do not timely file any non-provisional patent applications, we will lose our priority date and any patent protection on the inventions disclosed in any such provisional patent application. As of December 31, 2025, we have no pending PCT applications.
The Biodesix Louisville, Colorado clinical laboratory received approval from the NYSDOH, NYS CLEP in Soluble Tumor Markers, and Molecular and Cellular Tumor Markers and Virology as well as held state permits and licenses in California, Maryland, New York, Pennsylvania, and Rhode Island.
The Biodesix Louisville, Colorado clinical laboratory received approval from the NYSDOH, NYS CLEP in Soluble Tumor Markers, 13 and Molecular and Cellular Tumor Markers as well as held state permits and licenses in California, Maryland, New York, Pennsylvania, and Rhode Island.
We regularly engage our team members in monthly all-hands meetings to align and focus on the current state of affairs of our business, our partnerships, new products, clinical trials, and other pertinent information about our business.
We regularly engage our team members in quarterly all-hands meetings to align and focus on the current state of affairs of our business, our partnerships, new products, clinical trials, and other pertinent information about our business.
Competition We primarily face competition from diagnostic companies, all of whom provide cancer-focused diagnostic tests to hospitals, researchers, clinicians, and biopharmaceutical companies. Diagnosis—Nodule Management We are not aware of any other company that offers two commercial blood-based tests to help physicians reclassify risk of malignancy in patients with suspicious lung nodules.
Competition We primarily face competition from diagnostic companies that provide cancer-focused diagnostic tests to hospitals, researchers, clinicians, and biopharmaceutical companies. Diagnosis—Nodule Management We are not aware of any other company that offers commercial blood-based tests to help physicians reclassify risk of malignancy in patients with suspicious lung nodules.
Environmental, Health and Safety Regulations We are subject to various federal, state, local, and foreign environmental, health and safety laws and regulations and permitting and licensing requirements. Such laws include those governing laboratory practices, the generation, storage, use, manufacture, handling, transportation, treatment, remediation, release and disposal of, and exposure to potential bloodborne pathogens, hazardous materials and associated wastes.
Environmental, Health and Safety Regulations We are subject to various federal, state, local, and foreign environmental, health and safety laws and regulations and permitting and licensing requirements. Such laws include those governing laboratory practices, the generation, storage, use, manufacture, handling, transportation, treatment, remediation, release and disposal of, and exposure to potential blood-borne pathogens, hazardous materials and associated wastes.
We therefore believe that there is a clear clinical need for blood-based diagnostic testing to help improve the initial risk assessment of pulmonary nodules, helping direct patients to the relevant treatment pathway, and ultimately improving patient outcomes and saving costs to the system. • Treatment Guidance – Early Stage : We estimate that there are over 700 thousand testing opportunities annually in the United States in early-stage lung cancer to assess a patient’s risk of recurrence following curative-intent surgery, and to detect potential target mutations for therapeutics.
We believe that there is a strong patient and clinical need for blood-based diagnostic testing to help improve the initial risk assessment of pulmonary nodules, helping direct patients to the relevant treatment pathway, ultimately improving patient outcomes and saving costs to the system across the lung care pathway. • Treatment Guidance – Early Stage : We estimate that there are over 700 thousand testing opportunities annually in the United States in early-stage lung cancer to assess a patient’s risk of recurrence following curative-intent surgery, and to detect potential target mutations for therapeutics.
"Cybersecurity" for additional information on our cybersecurity practices. Healthcare Reform In March 2010, the Patient Protection and Affordable Care Act (ACA) was enacted in the United States. The ACA made a number of substantial changes to the way healthcare is financed both by governmental and private insurers.
"Cybersecurity" for additional information on our cybersecurity practices. Healthcare Reform In March 2010, the Patient Protection and Affordable Care Act (ACA) was enacted in the United States, which provided a number of substantial changes to the way healthcare is financed both by governmental and private insurers.
For certain risks related to our status as an emerging growth company, see “Risk Factors—General Risk Factors—We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.” Human Capital Resources Our culture is underpinned by our cultural beliefs including an unwavering commitment to inclusion and diversity.
For certain risks related to our status as a smaller reporting company, see “Risk Factors—General Risk Factors—We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.” Human Capital Resources Our culture is underpinned by our cultural beliefs including an unwavering commitment to inclusion and diversity.
A predicate device is a legally marketed device that is not subject to a PMA, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and therefore a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was previously found substantially equivalent through the 510(k) process.
A predicate device is a legally marketed device that is not subject to a PMA, i.e., a Class I or II device that was legally marketed prior to May 28, 1976 (pre-amendments device), a device that has been reclassified from Class III to Class II or I, or a device that was previously found substantially equivalent through the 510(k) process.
The rule amends the current good manufacturing practice requirements of the QSR in 21 CFR 820. The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.
The rule amends the current good manufacturing practice requirements of the QSR in 21 CFR 820. The FDA’s Quality Management System Regulation (QMSR) rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.
Bio-Rad, as described below, is the sole source supplier for our GeneStrat test. Freenome's United States operations (formerly "Oncimmune USA" or "Oncimmune") is also the sole source supplier for our Nodify CDT tests but there are known secondary suppliers for these materials. We entered into a nonexclusive license and supply agreement with Bio-Rad in August 2019.
Freenome's United States operations (formerly "Oncimmune USA" or "Oncimmune") is also the sole source supplier for our Nodify CDT tests but there are known secondary suppliers for these materials. We entered into a nonexclusive license and supply agreement with Bio-Rad in August 2019.
We continue to publish clinical data and health economics and outcomes research to support the ongoing adoption of our tests by physicians, healthcare systems, and payers. • Our commercial infrastructure and lung-focused sales channel, which includes our extensive knowledge and experience in sales, marketing, reimbursement and operations, provides us with the ability to efficiently launch and scale tests and drive revenue.
We continue to publish clinical data and health economics and outcomes research to support the ongoing adoption of our tests by physicians, healthcare systems, and payers. • Our commercial infrastructure, spanning both the lung-focused sales channel and the primary care referral network, which includes our extensive knowledge and experience in sales, marketing, reimbursement and operations, provides us with the ability to efficiently launch and scale tests and drive revenue.
The evaluation shall document that the applicable Essential Requirements/General Safety and Performance Requirements are met and document the evaluation of the undesirable side-effects and the acceptability of the benefit-risk ratio. The CER must be updated based on information from the post-market surveillance and vigilance activities related to the device.
The CER is part of the device’s technical file. The evaluation shall document that the applicable Essential Requirements/General Safety and Performance Requirements are met and document the evaluation of the undesirable side-effects and the acceptability of the benefit-risk ratio. The CER must be updated based on information from the post-market surveillance and vigilance activities related to the device.
Molecular pathology tests and most ADLTs are also generally required to be billed directly to Medicare by the laboratory under these circumstances. The Centers for Medicare & Medicaid Services (CMS) has designated three of the Biodesix tests as Advanced Diagnostic Laboratory Tests (ADLT).
Molecular 9 pathology tests and most ADLTs are also generally required to be billed directly to Medicare by the laboratory under these circumstances. CMS has designated three of the Biodesix tests as Advanced Diagnostic Laboratory Tests (ADLT).
We have a national annual community service initiative, “ Biodesix Gives Back ” that allows each team member to invest ten hours of paid community service to organizations of their choosing. As of December 31, 2024, we had approximately 273 full-time and part-time employees, all of whom are located in the United States.
We have a national annual community service initiative, “ Biodesix Gives Back ” that allows each team member to invest ten hours of paid community service to organizations of their choosing. As of December 31, 2025, we had approximately 334 full-time and part-time employees located in the United States.
Following the issuance of this CE Certificate, manufacturers may draw up the declaration of conformity and affix the CE mark to the devices covered by this CE Certificate. Manufacturers of medical devices must document in a clinical evaluation report (CER) the evaluation of the clinical data related to the device. The CER is part of the device’s technical file.
Following the issuance of this CE Certificate, manufacturers may draw up the declaration of conformity and affix the CE mark to the devices covered by this CE Certificate. In the EEA, manufacturers of medical devices must document in a clinical evaluation report (CER) the evaluation of the clinical data related to the device.
Colorado has enacted the Colorado Privacy Act, and Virginia has enacted the Consumer Data Protection Act, both of which also have standards that must be complied with that supplement Federal data protection requirements.
Colorado has enacted the Colorado Privacy Act, and Virginia has enacted the Consumer Data Protection Act, both of which also have standards that supplement Federal data protection requirements.
Nodify Lung testing consists of the Nodify CDT® and Nodify XL2® proteomic tests, which can be ordered separately or together from a single blood draw to help reclassify risk of cancer to aid physicians in stratifying patients into distinct nodule management pathways with the goal of earlier diagnosis of cancer and avoidance of unnecessary invasive procedures.
Nodify Lung testing consists of the Nodify CDT® and Nodify XL2® proteomic tests, which can be ordered separately or together from a single blood draw to help classify risk of cancer to aid healthcare providers in stratifying patients into distinct nodule management pathways with the goal of earlier diagnosis of cancer and avoidance of unnecessary invasive procedures when nodules are benign.
Should our current patent applications in prosecution in the United States issue, the resulting patents would be scheduled to have expiration dates between 2036 and 2040 (excluding any patent term extension(s) granted by the USPTO).
The patent related to the blood collection device is scheduled to expire in 2039. Should our current patent applications in prosecution in the United States issue, the resulting patents would be scheduled to have expiration dates between 2036 and 2040 (excluding any patent term extension(s) granted by the USPTO).
Magazine Best Workplaces – a reflection of our strong team culture and employee engagement. Our Strategy At Biodesix, we have built a team with deep experience in diagnostics including commercialization, reimbursement, regulatory, medical affairs, research and development, technology, and operations to provide needed products and services to address critical clinical questions and help improve patient care.
Our Strategy At Biodesix, we have built a team with deep experience in diagnostics including commercialization, reimbursement, regulatory, medical affairs, research and development, technology, and operations to provide needed products and services to address critical clinical questions and help improve patient care.
With the introduction of numerous treatment options, physicians need an ever-increasing amount of information in order to select the best treatment plan for each individual patient.
With the introduction of numerous treatment options, healthcare providers need an ever-increasing amount of information to select the best treatment plan for each individual patient.
The CCPA, among other things, gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California consumers (as that term is broadly defined) and provide such consumers new ways to opt-out of certain sales of personal information.
For instance, the California Consumer Privacy Act (CCPA), as amended by the passage of the California Privacy Rights Act (CPRA), among other things, gives California residents rights to access and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used by requiring covered companies to provide disclosures to California consumers (as that term is broadly defined) and provide such consumers ways to opt-out of certain sales of personal information.
Compliance with applicable laws and regulations, as well as internal compliance policies and procedures adds complexity to the billing process. The Centers for Medicare & Medicaid Services (CMS) is responsible for overseeing the establishment of new Healthcare Common Procedure Coding System (HCPCS) codes for billing the Medicare program and other payers.
Compliance with applicable laws and regulations, as well as internal compliance policies and procedures, adds complexity to the billing process. CMS is responsible for overseeing the establishment of new Healthcare Common Procedure Coding System (HCPCS) codes for billing the Medicare program and other payers. CMS continuously evaluates and implements changes to the Medicare billing, coding, and reimbursement processes.
In all, as of December 31, 2024, we have 16 uniquely registered United States trademarks, 8 of which (including Biodesix, VeriStrat, and GeneStrat) have received foreign issuances as well, with four trademarks pending approval from the USPTO.
In all, as of December 31, 2025, we have 13 uniquely registered United States trademarks, four of which (including Biodesix, VeriStrat, Nodify and GeneStrat) have received foreign issuances as well, with one trademark pending approval from the USPTO.
The goal is to drive test adoption through articulating the scientific and clinical evidence behind our tests, how they impact the clinical care of a patient, and how the tests can ultimately help to improve patient outcomes.
The goal is to drive test adoption through articulating the scientific and clinical evidence behind our tests, how they impact the clinical care pathway options, and how the tests can ultimately help to improve patient outcomes through earlier detection and treatment.
The majority of these tests are infectious disease and companion diagnostic IVDs. Reclassification would allow manufacturers of certain types of tests to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than the premarket approval pathway, the most stringent type of FDA medical device review.
Reclassification would allow manufacturers of certain types of tests to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than the premarket approval pathway, the most stringent type of FDA medical device review.
We currently offer two tests that assess the risk of cancer in lung nodules and three tests that provide treatment guidance after a lung cancer diagnosis. This is our clinical testing focus because lung cancer is the deadliest cancer in the United States with the majority of patients diagnosed with advanced disease.
We currently offer two tests that assess the risk of cancer in lung nodules and three tests that provide treatment guidance after a lung cancer diagnosis. Lung cancer is the deadliest cancer in the United States with most patients diagnosed late stage, with advanced disease.
Diagnosis – Nodule Management Our blood-based tests for patients with a pulmonary nodule, Nodify Lung Nodule Risk Assessment, assists physicians in reclassifying a patient’s risk of lung cancer by incorporating their protein biomarker results with radiographic imaging and clinical characteristics.
Diagnosis – Nodule Management Our blood-based tests for patients with a pulmonary nodule, Nodify Lung Nodule Risk Assessment, assists healthcare providers in classifying a patient’s risk of lung cancer by integrating their protein biomarker results with radiographic imaging (CT scans) and other clinical characteristics.
CMS continuously evaluates and implements changes to the Medicare billing, coding, and reimbursement processes. To receive reimbursement from third-party payers, we bill our tests using a variety of HCPCS codes or Current Procedural Terminology (CPT) codes, as defined by the American Medical Association.
To receive reimbursement from third-party payers, we bill our tests using a variety of HCPCS codes or Current Procedural Terminology (CPT) codes, as defined by the American Medical Association.
The use of the CDx will be stipulated in the labeling of both the CDx and the therapeutic product. The FDA may require an application for the CDx to be separate from the drug approval process, and this could potentially delay the approval of any new drug application or the CDx, or complicate the review process.
The FDA may also require an application for the CDx to be separate from the drug approval process, and this could also potentially delay the approval of any new drug application or the CDx, or complicate the review process.
If both tests are ordered for the patient and Nodify CDT returns a result of High or Moderate Level indicating an increased risk of malignancy, then the Nodify XL2 test is cancelled. If Nodify CDT returns a result of NSLAD, then the Nodify XL2 test is performed and both test results are typically available within four to five business days.
If both tests are ordered for the patient and the Nodify CDT test returns a result of High or Moderate Level indicating an increased risk of malignancy, then the Nodify XL2 test is cancelled.
In March 2024, we announced a Master Collaborative Research Agreement with Memorial Sloan Kettering Cancer Center, under which the teams are collaborating on a development plan for diagnostic tests aimed at improving the treatment of cancer, including MRD. Clinical Trials We are dedicated to continuously publishing and presenting new data on the clinical validation and utility of our diagnostic tests.
In March 2024, we announced a Master Collaborative Research Agreement with Memorial Sloan Kettering Cancer Center (MSKCC), under which the teams are collaborating on a development plan for diagnostic tests aimed at improving the treatment of cancer, including MRD.
The patents relating to the Nodify XL2 test are scheduled to expire beginning in 2031 (excluding any patent term extension granted by the United States Patent and Trademark Office (USPTO)), and the patents relating to the Nodify CDT test are scheduled to expire in 2027. The patent related to the blood collection device is scheduled to expire in 2039.
The patents relating to the Nodify XL2 test are scheduled to expire beginning in 2031 (excluding any patent term extension granted by the United States Patent and Trademark Office (USPTO)), and the patents relating to the Nodify CDT test are scheduled to expire in 2027 and are actively under review for additional protection.
EKRA (18 USC § 220) prohibits knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in return for the referral of a patient to, or in exchange for an individual using the services of certain entities, including laboratories, if the services are covered by a health care benefit program.
There are a number of statutory exceptions and regulatory safe harbors to the AKS that provide protection from AKS liability to arrangements that fully satisfy the applicable requirements. 18 EKRA (18 USC § 220) prohibits knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in return for the referral of a patient to, or in exchange for an individual using the services of certain entities, including laboratories, if the services are covered by a health care benefit program.
Primarily focusing on pulmonology, the commercial team, consisting of specialty sales representatives, medical affairs, marketing and customer care representatives, works to educate and inform the entire 6 patient care group consisting of physicians, nurses, office staff, laboratory personnel, and administration as to the appropriate use and value provided by our testing.
Primarily focusing on the pulmonology specialists and their primary care referral network, the Biodesix commercial team, consisting of specialty sales representatives, medical affairs, marketing and customer care representatives, works to educate and inform the entire patient care group consisting of pulmonologists, advanced pulmonary providers, the primary care referral network, nurses, office staff, laboratory personnel, and healthcare administrators on the appropriate use and value provided by our testing.
As a result, we believe our diagnostic services are not currently subject to the FDA’s enforcement of its medical device regulations and the applicable FDCA provisions.
We currently market our GeneStrat, VeriStrat, Nodify XL2 and Nodify CDT tests as LDTs in the United States. As a result, we believe our diagnostic services are not currently subject to the FDA’s enforcement of its medical device regulations and the applicable FDCA provisions.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWe cannot predict what other healthcare programs and regulations will ultimately be implemented at the federal or state level or the effect of any future legislation or regulation in the United States on our business, financial condition and results of operations.
Biggest changeWe cannot predict what other healthcare programs and regulations will ultimately be implemented at the federal or state level or the effect of any future legislation or regulation in the United States on our business, financial condition and results of operations. 38 The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may harm: • our ability to set a price that we believe is fair for our diagnostic tests; • our ability to generate revenue and achieve or maintain profitability; and • the availability of capital.
In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators.
In the United States, numerous federal and state laws and regulations, including state data breach notification laws, federal and state health information privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators.
Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies.
Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies.
For example: • others may be able to make diagnostic tests or products that are similar to our Nodify XL2, Nodify CDT, GeneStrat, GeneStrat NGS or VeriStrat tests or utilize similar technology that is not covered by the claims of our patents or that incorporates certain technology in our Nodify XL2, Nodify CDT, GeneStrat, GeneStrat NGS or VeriStrat tests; 61 • we, or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the applicable issued patent or pending patent application that we own or license now or may own or license in the future; • we, or our current or future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • it is possible that our current or future pending patent applications will not lead to issued patents; • issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties; • our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive diagnostic tests, products and services for sale in our major commercial markets; • we may not develop additional proprietary technologies that are patentable; • the patents of others may harm our business; and • we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property rights.
For example: • others may be able to make diagnostic tests or products that are similar to our Nodify XL2, Nodify CDT, GeneStrat, GeneStrat NGS or VeriStrat tests or utilize similar technology that is not covered by the claims of our patents or that incorporates certain technology in our Nodify XL2, Nodify CDT, GeneStrat, GeneStrat NGS or VeriStrat tests; • we, or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the applicable issued patent or pending patent application that we own or license now or may own or license in the future; • we, or our current or future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • it is possible that our current or future pending patent applications will not lead to issued patents; • issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties; • our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive diagnostic tests, products and services for sale in our major commercial markets; • we may not develop additional proprietary technologies that are patentable; • the patents of others may harm our business; and • we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property rights.
The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies or conformity assessment bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, one or more of the following enforcement actions: • untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; 45 • unanticipated expenditures to address or defend such actions; • customer notifications for repair, replacement, or refunds; • recall, detention, or seizure of our diagnostic tests; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying our requests for 510(k) clearance, De Novo authorization, or premarket approval of new diagnostic tests or modified versions of current diagnostic tests; • operating restrictions; • withdrawing 510(k) clearances, De Novo authorization, or PMA approvals that have already been granted; • revocation of EUAs that have been authorized previously; • refusal to grant export approval for our diagnostic tests; and • criminal prosecution.
The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies or conformity assessment bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, one or more of the following enforcement actions: • untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; • unanticipated expenditures to address or defend such actions; • customer notifications for repair, replacement, or refunds; • recall, detention, or seizure of our diagnostic tests; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying our requests for 510(k) clearance, De Novo authorization, or premarket approval of new diagnostic tests or modified versions of current diagnostic tests; • operating restrictions; • withdrawing 510(k) clearances, De Novo authorization, or PMA approvals that have already been granted; • revocation of EUAs that have been authorized previously; • refusal to grant export approval for our diagnostic tests; and • criminal prosecution.
The market price of our common stock is likely to be highly volatile and may fluctuate substantially due to many factors, including: • volume and customer mix for our Nodify XL2, Nodify CDT, GeneStrat ddPCR, GeneStrat NGS, and VeriStrat testing; • the introduction of new diagnostic tests or enhancements to such tests by us or others in our industry; • disputes or other developments with respect to our or others’ intellectual property rights; • our ability to develop, obtain regulatory clearance or approval or certification for, and market new and enhanced diagnostic tests on a timely basis; • product liability claims or other litigation; • quarterly variations in our results of operations or those of others in our industry; • media exposure of our diagnostic tests or of those of others in our industry; • changes in governmental regulations or in the status of our regulatory approvals or applications; • changes in earnings estimates or recommendations by securities analysts; and • general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
The market price of our common stock is likely to be highly volatile and may fluctuate substantially due to many factors, including: • volume and customer mix for our Nodify XL2, Nodify CDT, GeneStrat ddPCR, GeneStrat NGS, and VeriStrat testing; • the introduction of new diagnostic tests or enhancements to such tests by us or others in our industry; • disputes or other developments with respect to our or others’ intellectual property rights; • our ability to develop, obtain regulatory clearance or approval or certification for, and market new and enhanced diagnostic tests on a timely basis; 59 • product liability claims or other litigation; • quarterly variations in our results of operations or those of others in our industry; • media exposure of our diagnostic tests or of those of others in our industry; • changes in governmental regulations or in the status of our regulatory approvals or applications; • changes in earnings estimates or recommendations by securities analysts; and • general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
Restrictions under applicable United States federal and state healthcare laws and regulations include the following: • the federal Anti-Kickback Statute, a criminal law, prohibits, among other things, persons and entities from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, in cash or in kind, to induce or reward purchasing, leasing, ordering, or arranging for, referring, or recommending the purchase, lease, order of any good or service for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid; • the Eliminating Kickbacks in Recovery Act, which prohibits knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in return for the referral of a patient to, or in exchange for an individual using the services of certain entities, including laboratories, if the services are covered by a health care benefit program; • the Beneficiary Inducement Statute, which prohibits any person, organization, or entity from giving anything of value to a federal health care program beneficiary that is likely to induce or influence the beneficiary’s choice of provider, practitioner, or supplier for covered services; • the federal civil False Claims Act, which may be enforced through civil whistleblower or qui tam actions and is often used to enforce the federal Anti-Kickback Statute and other healthcare laws and regulations, imposes civil penalties and potential exclusion from federal healthcare programs, against individuals or entities for, among other things, knowingly presenting, or 40 causing to be presented, to the federal government, claims for payment that are false or fraudulent or for making a false record or statement material to an obligation to pay the federal government or for knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government; • federal criminal statutes created by HIPAA impose criminal liability for, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private insurance plans, or, in any matter involving a healthcare benefit program, for knowingly and willfully making materially false, fictitious, or fraudulent statements in connection with the delivery of or payment for health care benefits; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers.
Restrictions under applicable United States federal and state healthcare laws and regulations include the following: • the federal Anti-Kickback Statute, a criminal law, prohibits, among other things, persons and entities from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, in cash or in kind, to induce or reward purchasing, leasing, ordering, or arranging for, referring, or recommending the purchase, lease, order of any good or service for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid; 39 • the Eliminating Kickbacks in Recovery Act, which prohibits knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in return for the referral of a patient to, or in exchange for an individual using the services of certain entities, including laboratories, if the services are covered by a health care benefit program; • the Beneficiary Inducement Statute, which prohibits any person, organization, or entity from giving anything of value to a federal health care program beneficiary that is likely to induce or influence the beneficiary’s choice of provider, practitioner, or supplier for covered services; • the federal civil False Claims Act, which may be enforced through civil whistleblower or qui tam actions and is often used to enforce the federal Anti-Kickback Statute and other healthcare laws and regulations, imposes civil penalties and potential exclusion from federal healthcare programs, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or for making a false record or statement material to an obligation to pay the federal government or for knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government; • federal criminal statutes created by HIPAA impose criminal liability for, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private insurance plans, or, in any matter involving a healthcare benefit program, for knowingly and willfully making materially false, fictitious, or fraudulent statements in connection with the delivery of or payment for health care benefits; and • analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers.
Our failure to comply with applicable regulatory requirements could result in enforcement action by any such agency, which may include any of the following sanctions: • adverse publicity, warning letters, untitled letters, it has come to our attention letters, fines, injunctions, consent decrees and civil penalties; • repair, replacement, refunds, recall or seizure of our diagnostic tests; • operating restrictions, partial suspension, or total shutdown of production; • denial of our requests for regulatory clearance or premarket approval of new diagnostic tests or services, new intended uses, or modifications to existing diagnostic tests or services; • withdrawal of regulatory clearance or premarket approvals that have already been granted; or • criminal prosecution.
Our failure to comply with applicable regulatory requirements could result in enforcement action by any such agency, which may include any of the following sanctions: • adverse publicity, warning letters, untitled letters, it has come to our attention letters, fines, injunctions, consent decrees and civil penalties; • repair, replacement, refunds, recall or seizure of our diagnostic tests; • operating restrictions, partial suspension, or total shutdown of production; • denial of our requests for regulatory clearance or premarket approval of new diagnostic tests or services, new intended uses, or modifications to existing diagnostic tests or services; • withdrawal of regulatory clearance or premarket approvals that have already been granted; or 42 • criminal prosecution.
If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our diagnostic tests and services on a timely basis, if at all, and our business, operating results and prospects 47 may be adversely affected.
If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our diagnostic tests and services on a timely basis, if at all, and our business, operating results and prospects may be adversely affected.
Regardless of the merits or eventual outcome, liability claims may result in: • decreased demand for our diagnostic tests and services; • harm to our reputation; • initiation of investigations by regulators; 31 • costs to defend the related litigation; • a diversion of management’s time and our resources; • substantial monetary awards to trial participants or patients; • product recalls, withdrawals, or labeling, marketing, or promotional restrictions; • loss of revenue; • adverse impact on the market price of our common stock; and • exhaustion of any available insurance and our capital resources.
Regardless of the merits or eventual outcome, liability claims may result in: • decreased demand for our diagnostic tests and services; • harm to our reputation; • initiation of investigations by regulators; • costs to defend the related litigation; • a diversion of management’s time and our resources; • substantial monetary awards to trial participants or patients; • product recalls, withdrawals, or labeling, marketing, or promotional restrictions; • loss of revenue; • adverse impact on the market price of our common stock; and • exhaustion of any available insurance and our capital resources.
Government regulations specific to medical devices are wide ranging and govern, among other things: • test design, development, manufacture, and release; • laboratory and clinical testing, labeling, packaging, storage, and distribution; • product safety and efficacy; • premarketing clearance or approval; • service operations; • record keeping; • product marketing, promotion and advertising, sales, and distribution; 43 • post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals; • post-market approval studies; and • product import and export.
Government regulations specific to medical devices are wide ranging and govern, among other things: • test design, development, manufacture, and release; • laboratory and clinical testing, labeling, packaging, storage, and distribution; • product safety and efficacy; • premarketing clearance or approval; • service operations; • record keeping; • product marketing, promotion and advertising, sales, and distribution; • post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals; • post-market approval studies; and • product import and export.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining 64 with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
In addition, if claims for our tests are not submitted to payers on a timely basis, or if we fail to comply with applicable billing requirements, it could have an adverse effect on our revenue and our business. Third-party payers require us to identify the test for which we are seeking reimbursement using a Current Procedural Terminology (CPT) code.
In addition, if claims for our 49 tests are not submitted to payers on a timely basis, or if we fail to comply with applicable billing requirements, it could have an adverse effect on our revenue and our business. Third-party payers require us to identify the test for which we are seeking reimbursement using a Current Procedural Terminology (CPT) code.
Our continued success depends on our ability to: • further penetrate the lung disease diagnostic solutions market and increase utilization of our diagnostic tests; • maintain and widen our technology lead over competitors by continuing to innovate and deliver new product enhancements on a continuous basis; and • cost-effectively manufacture our diagnostic tests and their component parts as well as drive down the cost of service.
Our continued success depends on our ability to: • further penetrate the lung disease diagnostic solutions market and increase utilization of our diagnostic tests; • maintain and widen our technology lead over competitors by continuing to innovate and deliver new product enhancements on a continuous basis; and 31 • cost-effectively manufacture our diagnostic tests and their component parts as well as drive down the cost of service.
Furthermore, competitors may be able to design around our patents by developing similar or alternative technologies or products in a non-infringing manner, or obtain patent protection for more effective technologies, designs or methods, including for treating lung cancer. If these developments were to occur, our diagnostic tests and products may become less competitive and sales may decline.
Furthermore, competitors may be able to design around our patents by developing similar or alternative technologies or products in a non-infringing manner, or obtain patent protection for more effective technologies, designs or methods, including for 50 treating lung cancer. If these developments were to occur, our diagnostic tests and products may become less competitive and sales may decline.
Numerous significant intellectual property issues have been litigated, are being litigated and will likely continue to be litigated, between existing and new participants in our existing and targeted markets, and competitors have and may assert that our diagnostic tests or services infringe their intellectual property rights as part of a business strategy to impede our successful entry into or growth in those markets.
Numerous significant intellectual property issues have been litigated, are being litigated and will likely continue to be litigated, between existing and new participants in our existing and targeted markets, and competitors have and may assert 54 that our diagnostic tests or services infringe their intellectual property rights as part of a business strategy to impede our successful entry into or growth in those markets.
To the extent a pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section. Risks Related to our Governmental Regulation The insurance coverage and reimbursement status of newly approved diagnostic tests, particularly in a new category of diagnostics and therapeutics, is uncertain.
To the extent a pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section. 36 Risks Related to our Governmental Regulation The insurance coverage and reimbursement status of newly approved diagnostic tests, particularly in a new category of diagnostics and therapeutics, is uncertain.
As explained by the FDA in its update to this safety communication, the FDA sent notices to several firms marketing such pharmacogenetic tests where the FDA believes the relationship between genetic variations and the medication’s effects has not been established, including a warning letter sent to a laboratory, in part, for failing to obtain premarket review of its test.
As explained by the FDA in its update to this safety communication, the FDA sent notices to several firms 40 marketing such pharmacogenetic tests where the FDA believes the relationship between genetic variations and the medication’s effects has not been established, including a warning letter sent to a laboratory, in part, for failing to obtain premarket review of its test.
We believe that any disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
We believe that any disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities 61 that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
If we do not leverage or scale our sample and data biobank to discover new diagnostic tests or applications or update our diagnostic tests to reflect new scientific knowledge, including about lung 29 cancer biology, information about new cancer therapies or relevant clinical trials, our diagnostic tests could become obsolete and sales of our current diagnostic tests and any new tests we develop could decline or fail to grow as expected.
If we do not leverage or scale our sample and data biobank to discover new diagnostic tests or applications or update our diagnostic tests to reflect new scientific knowledge, including about lung cancer biology, information about new cancer therapies or relevant clinical trials, our diagnostic tests could become obsolete and sales of our current diagnostic tests and any new tests we develop could decline or fail to grow as expected.
We may need to obtain additional licenses from others to advance our research, development and commercialization activities. The in-licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to in-license or acquire third-party intellectual property rights that we may consider attractive or necessary.
We may need to obtain additional licenses from others to advance our research, development and commercialization activities. 56 The in-licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to in-license or acquire third-party intellectual property rights that we may consider attractive or necessary.
Without protection for the intellectual property rights we license, other companies might be able to offer substantially identical diagnostic tests for sale, which could adversely affect our competitive business position and harm our business prospects. 59 Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.
Without protection for the intellectual property rights we license, other companies might be able to offer substantially identical diagnostic tests for sale, which could adversely affect our competitive business position and harm our business prospects. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.
If any of our largest payers terminates its relationship with us or our tests are no longer reimbursable by such payer, such termination could negatively affect our revenues and results of operations. 30 Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for, and utilization of, our diagnostic tests and manage our inventory.
If any of our largest payers terminates its relationship with us or our tests are no longer reimbursable by such payer, such termination could negatively affect our revenues and results of operations. Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for, and utilization of, our diagnostic tests and manage our inventory.
The manufacturing preference requirement can be 60 waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.
The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.
This concentration of ownership may have the effect of delaying or preventing a change 63 of control and might adversely affect the market price of our common stock. This concentration of ownership may not be in the best interests of our other stockholders. Operating as a public company requires us to incur substantial costs and requires substantial management attention.
This concentration of ownership may have the effect of delaying or preventing a change of control and might adversely affect the market price of our common stock. This concentration of ownership may not be in the best interests of our other stockholders. Operating as a public company requires us to incur substantial costs and requires substantial management attention.
In addition, CMS may assign unique level II Healthcare Common Procedure Coding System codes to tests that are not already described by a unique CPT code. The VeriStrat, Nodify XL2, and Nodify CDT tests have test specific CPT codes, but the GeneStrat NGS test does not at this time.
In addition, CMS may assign unique level II Healthcare Common Procedure Coding System (HCPCS) codes to tests that are not already described by a unique CPT code. The VeriStrat, Nodify XL2, and Nodify CDT tests have test specific CPT codes, but the GeneStrat NGS test does not at this time.
Current Cybersecurity Risks As of the date of this Annual Report on Form 10-K, the Company has not experienced any cybersecurity threats or incidents that have materially affected or are reasonably likely to materially affect the Company. In the event of a cybersecurity incident, the Company is equipped with a well-defined incident response plan.
Current Cybersecurity Risks As of the date of this Annual Report on Form 10-K, the Company has not experienced any cybersecurity incidents that have materially affected or are reasonably likely to materially affect the Company. In the event of a cybersecurity incident, the Company is equipped with a well-defined incident response plan.
If the FDA disagrees and requires new clearances or approvals for the modifications, we may be required to recall and to stop marketing our diagnostic tests as modified, which could require us to redesign our diagnostic tests and harm our operating results. In these circumstances, we may be subject to significant enforcement actions.
If the FDA disagrees and requires new clearances or approvals for the modifications, we may be required to recall and to stop marketing our diagnostic tests as modified, which could require 43 us to redesign our diagnostic tests and harm our operating results. In these circumstances, we may be subject to significant enforcement actions.
Similarly, foreign courts have made, and will likely continue to 55 make, changes in how the patent laws in their respective jurisdictions are interpreted. We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by United States and foreign legislative bodies.
Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by United States and foreign legislative bodies.
In patent litigation in the United States, counterclaims alleging invalidity or unenforceability are commonplace. Grounds 58 for a validity challenge could be an alleged failure to meet any of several statutory requirements, including patent eligible subject matter, lack of novelty, obviousness or non-enablement.
In patent litigation in the United States, counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including patent eligible subject matter, lack of novelty, obviousness or non-enablement.
Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects. Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future diagnostic tests, products and services.
Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects. 52 Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future diagnostic tests, products and services.
If we are unable to continue to innovate and improve our diagnostic tests and services we offer, we could lose customers or market share; • Any failure to offer high-quality support for our diagnostic tests and services may adversely affect our relationships with providers and negatively impact our reputation among patients and providers, which may adversely affect our business, financial condition and results of operations; • We may face additional costs, loss of revenue, significant liabilities, harm to our brand, decreased use of our products or services and business disruption if there are any security or data privacy breaches or other unauthorized or improper access. 24 Risk Factors Our operations and financial results are subject to various risks and uncertainties that could adversely affect our business, financial condition, results of operations and cash flows.
If we are unable to continue to innovate and improve our diagnostic tests and services we offer, we could lose customers or market share; • Any failure to offer high-quality support for our diagnostic tests and services may adversely affect our relationships with providers and negatively impact our reputation among patients and providers, which may adversely affect our business, financial condition and results of operations; • We may face additional costs, loss of revenue, significant liabilities, harm to our brand, decreased use of our products or services and business disruption if there are any security or data privacy breaches or other unauthorized or improper access. 23 Risk Factors Our operations and financial results are subject to various risks and uncertainties that could adversely affect our business, financial condition, results of operations and cash flows.
The Perceptive Term Loan Facility contains certain covenants limiting our ability to, among other things, engage in certain corporate changes, make certain restricted payments, repay other certain indebtedness or enter into, amend or terminate any other agreements that have the impact of restricting our ability to make loan repayments.
The Perceptive Term Loan Facility also contains certain covenants limiting our ability to, among other things, engage in certain corporate changes, make certain restricted payments, repay other certain indebtedness or enter into, amend or terminate any other agreements that have the impact of restricting our ability to make loan repayments.
These diagnostic tests and products may compete with our diagnostic tests, products or services and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
These diagnostic tests and products may compete with our diagnostic tests, products or services and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. 58 Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
However, if we undergo an ownership change now or in the future, our ability to utilize NOLs and research and development credit carryforwards could be limited by Sections 382 and 383 of the Code. Future changes in stock ownership may be beyond our control.
If we undergo an ownership change now or in the future, our ability to utilize NOLs and research and development credit carryforwards could be limited by Sections 382 and 383 of the Code. Future changes in stock ownership may be beyond our control.
For these reasons, in the event we experience a change of control, we may not be able to utilize a material portion of the NOLs, research and development credit carryforwards or disallowed interest expense carryovers, even if we attain profitability.
For these reasons, in the event we experience a 34 change of control, we may not be able to utilize a material portion of the NOLs, research and development credit carryforwards or disallowed interest expense carryovers, even if we attain profitability.
Our present and future funding requirements will depend on many factors, including: • our ability to achieve revenue growth; • our rate of progress in establishing payer coverage and reimbursement arrangements with domestic and international commercial third-party payers and government payers; • the cost of expanding our laboratory operations and offerings, including our sales and marketing efforts; 36 • our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of and reimbursement for our diagnostic tests; • our rate of progress in, and cost of research and development activities associated with, diagnostic tests in research and early development; • the effect of competing technological and market developments; • costs related to international expansion; and • the potential cost of and delays in product development as a result of any regulatory oversight applicable to our diagnostic tests.
Our present and future funding requirements will depend on many factors, including: • our ability to achieve revenue growth; • our rate of progress in establishing payer coverage and reimbursement arrangements with domestic and international commercial third-party payers and government payers; • the cost of expanding our laboratory operations and offerings, including our sales and marketing efforts; • our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of and reimbursement for our diagnostic tests; • our rate of progress in, and cost of research and development activities associated with, diagnostic tests in research and early development; • the effect of competing technological and market developments; • costs related to international expansion; and 35 • the potential cost of and delays in product development as a result of any regulatory oversight applicable to our diagnostic tests.
Improvements in existing competitive diagnostic tests or the introduction 32 of new competitive diagnostic tests may make it more difficult for us to compete for sales, particularly if those competitive diagnostic tests demonstrate better reliability, convenience or effectiveness or are offered at lower prices.
Improvements in existing competitive diagnostic tests or the introduction of new competitive diagnostic tests may make it more difficult for us to compete for sales, particularly if those competitive diagnostic tests demonstrate better reliability, convenience or effectiveness or are offered at lower prices.
Due to the competitive nature of product offers and prices, we may not be able to obtain new, or maintain existing, contract positions with the EU Member States. Litigation and other legal proceedings may adversely affect our business.
Due to the competitive nature of product offers and prices, we may not be able to obtain new, or maintain existing, contract positions with the EU Member States. 32 Litigation and other legal proceedings may adversely affect our business.
These decisions state, among other 53 things, that a patent claim that recites an abstract idea, natural phenomenon, or law of nature (for example, the relationship between particular genetic variants and cancer) are not themselves patentable.
These decisions state, among other things, that a patent claim that recites an abstract idea, natural phenomenon, or law of nature (for example, the relationship between particular genetic variants and cancer) are not themselves patentable.
Additionally, some countries require approval of the sale price of a product before it can be marketed or mandatory discounts or profit caps may be applied. Further, after the sale price is approved, it remains subject to review during the product lifecycle.
Additionally, some countries require approval of the sale price of a product before it can be marketed or mandatory discounts or profit caps may be applied. Further, after the 37 sale price is approved, it remains subject to review during the product lifecycle.
In addition, we may not be able to establish or maintain 51 relationships with these parties on favorable terms, if at all. Each of these outcomes would harm our ability to market our tests, or to achieve sustained profitability.
In addition, we may not be able to establish or maintain relationships with these parties on favorable terms, if at all. Each of these outcomes would harm our ability to market our tests, or to achieve sustained profitability.
The confidentiality agreements are designed to protect our proprietary information and, in the case of agreements or clauses containing invention assignment, to grant us ownership of technologies that are developed through a relationship with employees or third parties.
The confidentiality agreements are designed to protect our proprietary information and, in 51 the case of agreements or clauses containing invention assignment, to grant us ownership of technologies that are developed through a relationship with employees or third parties.
Grounds for a validity challenge could include an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, written description, non-enablement or failure to claim patent-eligible subject matter.
Grounds for a 53 validity challenge could include an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, written description, non-enablement or failure to claim patent-eligible subject matter.
We will need to raise additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons, including to: • increase our sales and marketing efforts to drive market adoption of and address competitive developments; • fund development and marketing efforts of our diagnostic tests or any other future diagnostic tests; • expand our technologies into other types of cancer management and lung disease detection diagnostic tests; • acquire, license, or invest in technologies; • acquire or invest in complementary businesses or assets; and • finance capital expenditures and general and administrative expenses.
We may need to raise additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons, including to: • increase our sales and marketing efforts to drive market adoption of and address competitive developments; • fund development and marketing efforts of our diagnostic tests or any other future diagnostic tests; • expand our technologies into other types of cancer management and lung disease detection diagnostic tests; • acquire, license, or invest in technologies; • acquire or invest in complementary businesses or assets; and • finance capital expenditures and general and administrative expenses.
If these medical personnel, care partners or patients are not properly trained, are negligent or use our diagnostic tests incorrectly, the capabilities of such tests may be diminished or the patient may suffer critical injury.
If these medical personnel, care partners or patients 30 are not properly trained, are negligent or use our diagnostic tests incorrectly, the capabilities of such tests may be diminished or the patient may suffer critical injury.
We maintain and process, and our third-party vendors, collaborators, contractors and consultants maintain and process on our behalf, a large quantity of sensitive information, including confidential business, personal and patient health information in connection with our clinical studies and our employees, and are subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage and use of personally identifying information, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information.
We maintain and process, and our third-party vendors, collaborators, contractors and consultants maintain and process on our behalf, a large quantity of sensitive information, including confidential business, personal and patient health information in connection with our clinical studies and our employees, and are subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage and use of personal information, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information.
Any termination of this relationship, or delays in entering into new strategic partnership agreements with Bio-Rad, could delay our sales and marketing efforts, which would harm our business prospects, financial condition and results of operations. 28 We may not be able to sufficiently reduce costs in the performance, manufacturing and production of our diagnostic tests to achieve sustainable gross margins.
Any termination of this relationship, or delays in entering into new strategic partnership agreements with Bio-Rad, could delay our sales and marketing efforts, which would harm our business prospects, financial condition and results of operations. 27 We may not be able to sufficiently reduce costs in the performance, manufacturing and production of our diagnostic tests to achieve sustainable gross margins.
In addition, we could encounter delays in diagnostic test introductions while we attempt 57 to develop alternative diagnostic tests, products or services to avoid infringing third-party patents or intellectual property rights.
In addition, we could encounter delays in diagnostic test introductions while we attempt to develop alternative diagnostic tests, products or services to avoid infringing third-party patents or intellectual property rights.
As a result, capital appreciation, if any, of our common stock will be the sole source of gain for the foreseeable future. 65 1B. Unresolved S taff Comments. None. 1C. Cyberse curity. Risk Management and Strategy Our business depends on the secure and continuous processing of information, supported by a resilient IT infrastructure and trusted critical vendors.
As a result, capital appreciation, if any, of our common stock will be the sole source of gain for the foreseeable future. 63 1B. Unresolved S taff Comments. None. 1C. Cyberse curity. Risk Management and Strategy Our business depends on the secure and continuous processing of information, supported by a resilient IT infrastructure and trusted critical vendors.
Later discovery of previously unknown problems with our diagnostic tests, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such diagnostic tests or manufacturing processes, withdrawal of the diagnostic tests from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
Later discovery of previously unknown problems with our diagnostic tests, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as those applicable to our QMS, may result in changes to labeling, restrictions on such diagnostic tests or manufacturing processes, withdrawal of the diagnostic tests from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
The revenue attributable to 26 our biopharmaceutical customers may also fluctuate in the future, which could have a material adverse effect on our financial condition and results of operations. In addition, the termination of these relationships could result in a temporary or permanent loss of revenue.
The revenue attributable to 25 our biopharmaceutical customers may also fluctuate in the future, which could have a material adverse effect on our financial condition and results of operations. In addition, the termination of these relationships could result in a temporary or permanent loss of revenue.
In addition, IVDs and CDx tests are widely considered to be Class III devices, and it is possible that in the future, we may develop tests that fall into this category. CDx tests in particular may require further administrative procedures in the PMA process.
In addition, IVDs and CDx tests are widely considered to be Class III devices, and it is possible that in the future, we may develop tests that fall into this category. CDx tests in particular may require further administrative procedures in the IVD (PMA) submission process.
Beyond policies, our network is fortified with a multi-layered defense strategy, including firewalls and advanced cyber-threat monitoring. We employ 24/7 vulnerability scanning and extended detection and response (XDR) to continuously detect, analyze, and neutralize potential threats in real time. We recognize the importance of securing our extended digital ecosystem, including third-party service providers .
Beyond policies, our network is fortified with a multi-layered defense strategy, including firewalls and advanced cyber-threat monitoring. We employ continuous vulnerability management and 24/7 extended detection and response (XDR) to continuously detect, analyze, and neutralize potential threats in real time. We recognize the importance of securing our extended digital ecosystem, including third-party service providers .
On November 16, 2022 (Closing Date), we entered into a credit agreement and guaranty (the Credit Agreement) with Perceptive Credit Holdings IV, LP as the lender and administrative agent (the Lender) that provides for a senior secured delayed draw term loan facility with Perceptive Advisors LLC (Perceptive), in an aggregate principal amount of up to $50.0 million (the Perceptive Term Loan Facility) 35 to refinance long-term debt.
On November 16, 2022, we entered into a credit agreement and guaranty (the Credit Agreement) with Perceptive Credit Holdings IV, LP as the lender and administrative agent (the Lender) that provides for a senior secured delayed draw term loan facility with Perceptive Advisors LLC (Perceptive), in an aggregate principal amount of up to $50.0 million (the Perceptive Term Loan Facility) to refinance long-term debt.
Further, our historical results are not 27 necessarily indicative of results expected for any future period, and quarterly results are not necessarily indicative of the results to be expected for the full year or any other period, and accordingly should not be relied upon as indicative of future performance.
Further, our historical results are not 26 necessarily indicative of results expected for any future period, and quarterly results are not necessarily indicative of the results to be expected for the full year or any other period, and accordingly should not be relied upon as indicative of future performance.
For example, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act introduced in Congress would codify into law the term “in vitro clinical test” in order to create a new medical product category separate from medical devices that would include products currently regulated as in vitro diagnostics as well as LDTs.
For example, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act introduced in Congress would have codified into law the term “in vitro clinical test” in order to create a new medical product category separate from medical devices that would include products currently regulated as in vitro diagnostics as well as LDTs.
Securities analysts may not publish favorable research or reports about our business or may publish no information at all, which could cause our stock price or trading volume to decline. The trading market for our common stock develops is influenced to some extent by the research and reports that industry or financial analysts publish about us and our business.
Securities analysts may not publish favorable research or reports about our business or may publish no information at all, which could cause our stock price or trading volume to decline. The trading market for our common stock is partially influenced by the research and reports that industry or financial analysts publish about us and our business.
We will need to raise additional capital to fund our existing operations, develop our platform, commercialize new diagnostic tests or expand our operations.
We may need to raise additional capital to fund our existing operations, develop our platform, commercialize new diagnostic tests or expand our operations.
Our success will depend on our ability to retain senior management and to attract and retain qualified personnel in the future, including sales and marketing professionals, scientists, clinical specialists, and other highly skilled personnel and to integrate current and additional personnel in all departments.
We are highly dependent on our senior management and other key personnel. Our success will depend on our ability to retain senior management and to attract and retain qualified personnel in the future, including sales and marketing professionals, scientists, clinical specialists, and other highly skilled personnel and to integrate current and additional personnel in all departments.
Failure to achieve or maintain market acceptance and/or market share would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition and results of operations. 25 We may encounter difficulties in managing our growth, which could disrupt our operations. As of December 31, 2024, we had approximately 273 full and part-time employees.
Failure to achieve or maintain market acceptance and/or market share would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition and results of operations. 24 We may encounter difficulties in managing our growth, which could disrupt our operations. As of December 31, 2025, we had approximately 334 full and part-time employees.
Such law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to our best interests and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful; • we may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law; • we are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification; • the rights conferred in our amended and restated articles of incorporation are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons; and • we may not retroactively amend our amended and restated articles of incorporation provisions to reduce our indemnification obligations to directors, officers, employees and agents.
Such law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to our best interests and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful; • we may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law; • we are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification; • the rights conferred in our amended and restated articles of incorporation are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons; and • we may not retroactively amend our amended and restated articles of incorporation provisions to reduce our indemnification obligations to directors, officers, employees and agents. 62 We have never paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future.
Such occurrences, regardless of their outcome, could damage our reputation and adversely affect important business relationships with third parties, including managed care organizations, and other private third-party payers. The FDA has recently increased its attention to marketing of pharmacogenetic tests.
Such occurrences, regardless of their outcome, could damage our reputation and adversely affect important business relationships with third parties, including managed care organizations, and other private third-party payers. The FDA pays attention to marketing of pharmacogenetic tests.
For example, EU and UK data privacy laws have specific requirements relating to cross-border transfers of personal data to certain jurisdictions, including to the United States, have strict requirements relating to personal data collection, use or sharing, and have more stringent requirements relating to organizations’ privacy programs and provide stronger individual rights.
For example, some jurisdictions have specific requirements relating 46 to cross-border transfers of personal data to certain jurisdictions, including to the United States, have strict requirements relating to personal data collection, use or sharing, and have more stringent requirements relating to organizations’ privacy programs and provide stronger individual rights.
As a small reporting company and emerging growth company, we may be slow to attract research coverage and the analysts who publish information about our common stock will have had 62 relatively little experience with us, which could affect their ability to accurately forecast our results and could make it more likely that we fail to meet their estimates.
We do not control these analysts. As a small reporting company, we may be slow to attract research coverage and the analysts who publish information about our common stock will have had relatively little experience with us, which could affect their ability to accurately forecast our results and could make it more likely that we fail to meet their estimates.
If our operations are found to be in violation of any of the data protection laws described above or any other laws that apply to us, we may be subject to penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, 48 individual imprisonment, possible exclusion from participation in government healthcare programs, injunctions, private qui tam actions brought by individual whistleblowers in the name of the government, class action litigation and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corrective action plan or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our results of operations.
We may also be subject to penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, individual imprisonment, possible exclusion from participation in government healthcare programs, injunctions, private qui tam actions brought by individual whistleblowers in the name of the government, class action litigation and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corrective action plan or other agreement to resolve allegations of non-compliance with these laws, any of which could adversely affect our ability to operate our business and our results of operations.
Disruptions due to prior pandemics or potential disruptions due to the government imposed restrictions have included, and in the future may continue to include: the inability of our suppliers to manufacture components and parts and to deliver these to us on a timely basis, or at all; disruptions in our production schedule and ability to assemble diagnostic tests; inventory shortages or obsolescence; delays in actions of regulatory bodies; diversion of or limitations on employee resources that would otherwise be focused on the operations of our business; delays in growing or reductions in our sales organization, including through delays in hiring, lay-offs, furloughs or other losses of sales representatives; business adjustments or disruptions of certain third parties, including suppliers, medical institutions and clinical investigators with whom we conduct business; and additional government requirements or other incremental mitigation efforts that may further impact our or our suppliers’ capacity to manufacture our diagnostic tests. 37 The extent to which a future pandemic or epidemic impacts our business will depend on future facts and circumstances, which are highly uncertain and cannot be predicted.
Disruptions due to prior pandemics or potential disruptions due to the government imposed restrictions have included, and in the future may continue to include: the inability of our suppliers to manufacture components and parts and to deliver these to us on a timely basis, or at all; disruptions in our production schedule and ability to assemble diagnostic tests; inventory shortages or obsolescence; delays in actions of regulatory bodies; diversion of or limitations on employee resources that would otherwise be focused on the operations of our business; delays in growing or reductions in our sales organization, including through delays in hiring, lay-offs, furloughs or other losses of sales representatives; business adjustments or disruptions of certain third parties, including suppliers, medical institutions and clinical investigators with whom we conduct business; and additional government requirements or other incremental mitigation efforts that may further impact our or our suppliers’ capacity to manufacture our diagnostic tests.
If we achieve profitability, we may not be able to sustain it. We have incurred losses since our inception and expect to continue to incur losses for the foreseeable future. We reported net losses of $42.9 million and $52.1 million for the years ended December 31, 2024 and 2023, respectively.
If we achieve profitability, we may not be able to sustain it. We have incurred losses since our inception and expect to continue to incur losses for the foreseeable future. We reported net losses of $35.3 million and $42.9 million for the years ended December 31, 2025 and 2024, respectively.
Our directors, officers and principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders. Our officers, directors and principal stockholders each holding more than 5% of our common stock collectively control approximately 44.0% of our outstanding common stock as of December 31, 2024.
Our directors, officers and principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders. Our officers, directors and principal stockholders each holding more than 5% of our common stock collectively control approximately 41.2% of our outstanding common stock as of December 31, 2025.
Our operations also produce hazardous and biological waste products. 52 Accordingly, we and our third-party manufacturers and suppliers are subject to federal, state, local and foreign environmental, health and safety laws and regulations, and permitting and licensing requirements, including those governing the generation, use, manufacture, storage, handling, transportation, release and disposal of, and exposure to, these materials, and worker health and safety.
Accordingly, we and our third-party manufacturers and suppliers are subject to federal, state, local and foreign environmental, health and safety laws and regulations, and permitting and licensing requirements, including those governing the generation, use, manufacture, storage, handling, transportation, release and disposal of, and exposure to, these materials, and worker health and safety.
Failure to comply with the GDPR and other countries’ privacy or data security-related laws, rules or regulations could result in material penalties imposed by regulators, affect our compliance with contracts entered into with our collaborators and other third-party payers, and have an adverse effect on our business and financial condition.
Failure to comply with U.S. or global privacy or data security-related laws, rules or regulations could result in significant penalties imposed by regulators, affect our compliance with contracts entered into with our collaborators and other third-party payers, and have an adverse effect on our business and financial condition.
Moreover, if disputes over intellectual property rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, or are insufficient to provide us the necessary rights to use the intellectual property rights, we may be unable to successfully develop and commercialize any affected diagnostic tests, products or services, which could have a material adverse effect on our business, financial conditions, results of operations and prospects.
Moreover, if disputes over intellectual property rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, or are insufficient to provide us the necessary rights to use the intellectual property rights, we may be unable to successfully develop and commercialize any affected diagnostic tests, products or services, which could have a material adverse effect on our business, financial conditions, results of operations and prospects. 57 Absent the license agreements, we may infringe patents subject to those agreements, and if the license agreements are terminated, we may be subject to litigation by the licensor.
Global macroeconomic conditions and the world’s financial markets remain susceptible to significant stresses, resulting in reductions in available credit and government spending, economic downturn or stagnation, foreign currency fluctuations and volatility in the valuations of securities generally.
General economic and financial market conditions may exacerbate our business risks. Global macroeconomic conditions and the world’s financial markets remain susceptible to significant stresses, resulting in reductions in available credit and government spending, economic downturn or stagnation, foreign currency fluctuations and volatility in the valuations of securities generally.
Our Information Security Officer is continually informed about the latest developments in cybersecurity. This is crucial for the effective prevention, detection, mitigation and remediation of cybersecurity incidents, and allows him to regularly inform our Chief Executive Officer and Chief Financial Officer of any and all aspects of our business related to cybersecurity and information technology.
This is crucial for the effective prevention, detection, mitigation and remediation of cybersecurity incidents, and allows him to regularly inform our Chief Executive Officer and Chief Financial Officer of any and all aspects of our business related to cybersecurity and information technology.
Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA. We may initiate voluntary recalls involving our diagnostic tests and services in the future that we determine do not require notification of the FDA. If the FDA disagrees with our determinations, they could require us to report those actions as recalls.
We may initiate voluntary recalls involving our diagnostic tests and services in the future that we determine do not require notification of the FDA. If the FDA disagrees with our determinations, they could require us to report those actions as recalls.
As discussed above, we believe that our current line of diagnostic tests and their components are LDTs, which are subject to state licensing requirements and federal regulation by CMS under CLIA, which may cause us to be subject to additional FDA regulations discussed above.
As discussed above, we believe that our current line of diagnostic tests and their components are LDTs, which are subject to state licensing requirements and federal regulation by CMS under CLIA.
Pursuant to this enforcement discretion policy, FDA does not require laboratories that furnish LDTs to comply with the agency’s requirements for medical devices (e.g., establishment registration, device listing, quality systems regulations, premarket clearance or premarket approval, and post-market controls).
Pursuant to this enforcement discretion policy, FDA does not require laboratories that furnish LDTs to comply with the agency’s requirements for medical devices (e.g., establishment registration, device listing, quality systems regulations, premarket clearance or premarket approval, and post-market controls). FDA attempted to end this policy of enforcement discretion in a May 6, 2024, final rule.
Although the FDA has asserted that it has authority to regulate the development and use of LDTs, such as our and many other laboratories’ tests, as medical devices, it has generally exercised enforcement discretion and is currently not otherwise regulating most tests developed and performed within a single high complexity CLIA-certified laboratory.
Historically, the FDA has asserted that it has authority to regulate the development and use of LDTs, such as our and many other laboratories’ tests, as medical devices, although it has generally claimed to exercise enforcement discretion over most tests developed and performed within a single high complexity CLIA-certified laboratory.
In particular, we and our suppliers may be required to comply with FDA’s QSR (QSR codified at 21 C.F.R. § 820) for medical devices and ISO regulations for the manufacture of our diagnostic tests and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any diagnostic test for which we obtain clearance or approval.
In particular, we and our suppliers may be required to comply with the FDA’s regulatory requirements for quality systems and other current good manufacturing practices of medical devices (codified at 21 CFR Part 820), ISO regulations for the manufacture of our diagnostic tests and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any diagnostic test for which we obtain clearance or approval.
We work with materials, including chemicals, biological agents and compounds and samples that could be hazardous to human health and safety or the environment.
We work with materials, including chemicals, biological agents and compounds and samples that could be hazardous to human health and safety or the environment. Our operations also produce hazardous and biological waste products.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe Company relocated its corporate headquarters to Louisville, Colorado in December 2023. We also lease office and laboratory space located in De Soto, Kansas, under an operating lease agreement 66 that expires in October 2026. A portion of our employees are located outside of Colorado and Kansas, and others work from home.
Biggest changeItem 2. Pro perties. The Company’s corporate headquarters are in Louisville, Colorado, under a lease agreement with Centennial Valley Properties I, LLC, a Colorado limited liability company. We also lease office and laboratory space located in De Soto, Kansas, under an operating lease 64 agreement that expires in June 2030.
Our properties are suitable for our current business operations. Location Use Square Feet Expiration Louisville, Colorado Office and laboratory 79,980 March 31, 2035 De Soto, Kansas Office and laboratory 9,066 October 31, 2026
A portion of our employees are located outside of Colorado and Kansas, working remotely. Our properties are suitable for our current business operations. Location Use Square Feet Expiration Louisville, Colorado Office and laboratory 79,980 March 31, 2035 De Soto, Kansas Office and laboratory 10,838 June 30, 2030
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Item 2. Pro perties. In March 2022, the Company entered into a lease agreement (the CVP Lease) with Centennial Valley Properties I, LLC, a Colorado limited liability company for office and laboratory space in Louisville, Colorado. In August 2022, CVP assigned the lease to CVP I Owner LLC, within the terms allowing for the assignment of the lease.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeWe are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, results of operations, financial condition, or cash flows. Item 4. Mine Saf ety Disclosures. None. 67 PART II
Biggest changeWe are not presently a party to any legal proceedings that, if determined adversely to us, would individually or taken together have a material adverse effect on our business, results of operations, financial condition, or cash flows. Item 4. Mine Saf ety Disclosures. None. 65 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe high and low closing prices for our common stock on The NASDAQ Global Market from January 1, 2023 to December 31, 2024 were $2.12 and $1.19, respectively. Holders of our Common Stock As of February 24, 2025, there were approximately 222 holders of our common stock.
Biggest changeThe high and low closing prices for our common stock on The Nasdaq Global Market from January 1, 2025 to December 31, 2025 were $29.80 and $4.40, respectively. On September 15, 2025, the Company effected a 1-for-20 reverse stock split. Holders of our Common Stock As of February 20, 2026, there were approximately 228 holders of our common stock.
The Subscription Agreements did not include any registration rights. The Company used the proceeds for the commercial expansion of sales, research and development, and for general corporate purposes (see – Item 8. "Financial Statements and Supplementary Data"). Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Item 6. [ Reserved] 68
The Company used the proceeds for the commercial expansion of sales, research and development, and for general corporate purposes (see – Item 8. "Financial Statements and Supplementary Data"). Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Item 6. [ Reserved] 66
Removed
On August 3, 2023, the Company entered into subscription agreements (the August 2023 Subscription Agreements) with all of the members of our Board of Directors, all Section 16 officers, and additional members of the Biodesix leadership team (together, the Investors) for the issuance and sale by the Company of an aggregate of 16,975,298 shares of the Company’s common stock at a purchase price (determined in accordance with NASDAQ rules relating to the “Minimum Value” of the Company’s common stock) of $1.62 per share for an aggregate purchase price of approximately $27.5 million.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeFourth Quarter and Full Year 2024 Financial and Operational Highlights The following were significant developments affecting our business, capital structure and liquidity during the year ended December 31, 2024 as compared to the same period in 2023 unless otherwise noted: • Total revenue of $20.4 million and $71.3 million for the fourth quarter and fiscal 2024, respectively, an increase of 39% and 45% over the respective prior year comparable periods; o Lung Diagnostic Testing revenue of $17.2 million and $64.7 million for the fourth quarter and fiscal 2024, respectively, an increase of 34% and 43% over the respective prior year comparable periods; primarily driven by an increase in total tests delivered; o Development Services revenue of $3.2 million and $6.6 million for the fourth quarter and fiscal 2024, respectively, an increase of 72% and 70% over the respective prior year comparable periods; • Gross margin was $16.1 million, or 79%, and $55.8 million, or 78%, for the fourth quarter and fiscal 2024, respectively, as a percentage of revenue compared to 77% and 73% in the prior year comparable periods, primarily driven by growth in Lung Diagnostic testing and optimization of testing workflows that resulted in improvements in costs per test and the ongoing expansion of our Diagnostic Services business; • Operating expenses (excluding direct costs and expenses) of $22.7 million and $90.2 million for the fourth quarter and fiscal 2024, an increase of 25% and 17% over the respective prior year comparable periods; o Increase in operating expenses is primarily attributed to an increase in sales and marketing costs to support Lung Diagnostic sales growth, as well as to enhance Biodesix awareness and drive product adoption; o Includes non-cash stock compensation expense of $1.3 million and $6.6 million during fourth quarter and fiscal 2024, respectively, an increase of 17% and 24% over the respective prior year comparable periods; • Net loss of $8.3 million and $42.9 million for the fourth quarter and fiscal 2024, respectively, an improvement of 10% and 18% over the respective prior year comparable periods; • Cash and cash equivalents of $26.2 million as of December 31, 2024.
Biggest changeFourth Quarter and Full Year 2025 Financial and Operational Highlights The following were significant developments affecting our business, capital structure and liquidity during the year ended December 31, 2025 as compared to the same period in 2024 unless otherwise noted: • Diagnostic Tests core organic revenue, excluding collection on claims older than one year, was $24.1 million in Q4, growth of 40% over the prior year comparable period, driven by test volume growth of 23% and increased average revenue per test; o Diagnostic Test revenue of $25.1 million and $79.2 million for the fourth quarter and fiscal 2025, respectively, an increase of 46% and 22% over the prior year comparable periods.
Components of Operating Results Revenues We derive our revenue from two sources: (i) Biodesix Lung Diagnostic Testing (Lung Diagnostic Testing), providing lung diagnostic testing services for healthcare providers associated with our five blood-based tests and (ii) Biodesix Development Services (Development Services) providing diagnostic testing services to biopharmaceutical, life sciences, and diagnostic companies.
Components of Operating Results Revenues We derive our revenue from two sources: (i) Biodesix Diagnostic Tests (Diagnostic Tests), providing lung diagnostic testing services for healthcare providers associated with our five blood-based tests and (ii) Biodesix Development Services (Development Services) providing diagnostic testing services to biopharmaceutical, life sciences, and diagnostic companies.
The Company generates revenues from (i) Lung Diagnostic Tests and (ii) assay development, testing services, and licensing our technologies (Development Services). The Company recognizes revenues related to blood-based lung diagnostic billings based on estimates of the amounts ultimately expected to be collected from customers on a portfolio approach.
The Company generates revenues from (i) Diagnostic Tests and (ii) assay development, testing services, and licensing our technologies (Development Services). The Company recognizes revenues related to blood-based lung diagnostic billings based on estimates of the amounts ultimately expected to be collected from customers on a portfolio approach.
On November 1, 2024, the Company filed a shelf registration statement on Form S-3 and entered into a new sales agreement with a financial institution, pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $50.0 million, subject to terms and conditions (the 2024 ATM Program).
On November 1, 2024, the Company filed a shelf registration statement on Form S-3 and entered into a new sales agreement with a financial institution, pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an 74 aggregate offering price of up to $50.0 million, subject to terms and conditions (the 2024 ATM Program).
We offer end-to-end diagnostic solutions, including translational research, initial biomarker discovery, assay design, development, and validation, testing of clinical trial samples, regulatory, reimbursement, commercialization, and logistical support services. We offer our existing on-market tests, a suite of other research tests and the capability to custom design novel tests for use by our customers.
We offer end-to-end diagnostic solutions, including translational research, initial biomarker discovery, assay design, development, and validation, testing of clinical trial samples, regulatory, reimbursement, commercialization, and logistical support services. We offer our existing on-market tests, a suite of other research tests and the capability to custom design and develop novel tests for use by our customers.
We employ multiple technologies, including genomics, proteomics, and radiomics, combined with artificial intelligence (AI), to discover, develop, and commercialize innovative diagnostic tests for physicians, biopharmaceutical, life science, and diagnostics companies to help improve patient care. Our Biodesix Lung Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease.
We employ multiple technologies, including genomics, proteomics, and radiomics, combined with artificial intelligence (AI), to discover, develop, and commercialize innovative diagnostic tests for physicians, biopharmaceutical, life science, and diagnostics companies to help improve patient care. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease.
Sales, marketing, general and administrative Our sales and marketing expenses are expensed as incurred and include costs associated with our sales organization, including our direct sales force and sales management, client services, marketing, public relations, communications and reimbursement, as well as business development personnel who are focused on our biopharmaceutical customers.
Sales, marketing, general and administrative Our sales and marketing expenses are expensed as incurred and include costs associated with our sales organization, including our direct sales force and sales management, client services, marketing, public relations, communications and reimbursement, as well as business development personnel who are focused on projects with our biopharmaceutical customers.
During the three months ended December 31, 2023, the Company met the remaining conditions precedent associated with the Tranche B Loan and, on December 15, 2023, the Company exercised its ability to draw the Tranche B loan for $10.0 million (the Tranche B Loan).
During the three months ended December 31, 2023, the Company met the conditions precedent associated with the Tranche B Loan and, on December 15, 2023, the Company exercised its ability to draw the Tranche B loan for $10.0 million (the Tranche B Loan).
On November 21, 2022, the Company entered into a Credit Agreement and Guaranty (the Credit Agreement) with Perceptive Credit Holdings IV, LP (Perceptive) as lender and administrative agent (the Lender) for up to $50.0 million, with funding of $30.0 million and the issuance of warrants exercisable into 3,000,000 shares of the Company’s common stock occurring on November 21, 2022, and two additional contingently issuable tranches of $10.0 million each subject to certain terms and conditions, including revenue milestones.
On November 21, 2022, the Company entered into a Credit Agreement and Guaranty (the Credit Agreement) with Perceptive Credit Holdings IV, LP (Perceptive) as lender and administrative agent (the Lender) for up to $50.0 million, with funding of $30.0 million and the issuance of warrants exercisable into 150,000 shares of the Company’s common stock occurring on November 21, 2022, and two additional contingently issuable tranches of $10.0 million each subject to certain terms and conditions, including revenue milestones.
Data for the years ended December 31, 2024 and 2023 has been derived from our audited financial statements included in this Annual Report on Form 10-K. Overview We are a leading diagnostic solutions company and our mission is to transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.
Data for the years ended December 31, 2025 and 2024 has been derived from our audited financial statements included in this Annual Report on Form 10-K. Overview We are a leading diagnostic solutions company, and our mission is to transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.
Biodesix, Inc. is referred to throughout this Annual Report on Form 10-K for the period ended December 31, 2024 (Form 10-K) as “we”, “us”, “our” or the “Company.” The following discussion of our financial condition and results of operations should be read together with our audited financial statements and related notes and other financial information included elsewhere in this Annual Report on Form 10-K.
Biodesix, Inc. is referred to throughout this Annual Report on Form 10-K for the period ended December 31, 2025 (Form 10-K) as “we”, “us”, “our” or the “Company.” The following discussion of our financial condition and results of operations should be read together with our audited financial statements and related notes and other financial information included elsewhere in this Annual Report on Form 10-K.
We believe that establishing a new standard of care utilizing personalized diagnostics requires a deep understanding of clinical needs, scientific expertise to develop tests using the optimal technology for each clinical question, development of clinical evidence to demonstrate benefits of the testing, a scalable operational infrastructure, and an established commercial channel to drive market adoption and payer coverage.
We believe that establishing a new standard of care utilizing personalized diagnostics requires an extensive understanding of clinical needs, scientific expertise to develop tests using the optimal technology for each clinical question, development of clinical evidence to demonstrate benefits of the testing, a scalable operational infrastructure, and an established commercial channel to drive market adoption and payer coverage.
On June 27, 2023, we completed enrollment of 5,000 patients with non-small cell lung cancer. All study participants currently enrolled in the study are expected to complete study follow-up by 2026. The participant data will be monitored, and sites will be closed accordingly throughout 2025.
On June 27, 2023, we completed enrollment of 5,000 patients with non-small cell lung cancer. All study participants currently enrolled in the study are expected to complete study follow-up by the end of 2026. The participant data will be monitored, and sites will be closed accordingly throughout 2026.
Further we also expect to increase our research and development expenses to fund further innovation and develop new clinically relevant tests. • Ability to attract new biopharmaceutical customers and maintain and expand relationships with existing customers. Our business development team promotes the broad utility of our products for biopharmaceutical companies in the United States and internationally.
Further, we also expect to increase our research and development expenses to fund further innovation and develop new clinically relevant tests. • Ability to attract new Development Services including biopharmaceutical customers and maintain and expand relationships with existing customers. Our business development team promotes the broad utility of our products for biopharmaceutical companies in the United States and internationally.
The Company amended the Indi APA agreement in April 2022 in which all parties agreed to restructure the Milestone Payments whereby the Company will make five quarterly installments of $2.0 million each beginning in April 2022, three quarterly installments of $3.0 million beginning in July 2023, one installment of $5.0 million in April 2024, and one installment of approximately $8.4 million in July 2024.
The Company amended the Indi APA agreement in April 2022 in which all parties agreed to restructure the milestone payments whereby the Company would make five quarterly installments of $2.0 million each beginning in April 2022, three quarterly installments of $3.0 million beginning in July 2023, one installment of $5.0 million in April 2024, and one installment of approximately $8.4 million in July 2024.
If we are not able to obtain or maintain coverage and adequate reimbursement from third-party payers, we may not be able to effectively increase our testing volume and revenue 70 as expected. Additionally, retrospective reimbursement adjustments can negatively impact our revenue and cause our financial results to fluctuate.
If we are not able to obtain or maintain coverage and adequate reimbursement from third-party payers, we may not be able to effectively increase our testing volume and revenue 68 as expected. Additionally, retrospective reimbursement adjustments can negatively impact our revenue and cause our financial results to fluctuate.
(2) Includes the Perceptive Term Loan payments of principal and interest. Interest amounts associated with the Perceptive Term Loan are variable and estimated based on the interest rate in effect at December 31, 2024. Off-Balance Sheet Arrangements As of December 31, 2024, we have not entered into any off-balance sheet arrangements.
(2) Includes the Perceptive Term Loan payments of principal and interest. Interest amounts associated with the Perceptive Term Loan are variable and estimated based on the interest rate in effect at December 31, 2025. Off-Balance Sheet Arrangements As of December 31, 2025, we have not entered into any off-balance sheet arrangements.
Lung Diagnostic Testing Lung Diagnostic test revenue is generated from delivery of results from our diagnostic tests. In the United States, we performed tests as both an in-network and out-of-network service provider depending on the test performed and the contracted status of the insurer.
Diagnostic Tests Diagnostic Tests revenue is generated from delivery of results from our diagnostic tests. In the United States, we performed tests as both an in-network and out-of-network service provider depending on the test performed and the contracted status of the insurer.
We consider diagnostic testing to be completed upon the delivery of test results to our customer, either the prescribing physician or third-party to which we contracted for services to be performed, which is considered the performance obligation.
We consider diagnostic testing to be completed upon the delivery of test results to our customer, either the prescribing physician or healthcare provider or third-party to which we contracted for services to be performed, which is considered the performance obligation.
The increase in costs for the year ended December 31, 2024 was primarily driven by the increase in testing volume compared to the same period in 2023, partially offset by the optimization of testing workflows that resulted in improvements in costs per test.
The increase in costs for the year ended December 31, 2025 was primarily driven by the increase in testing volume compared to the same period in 2024, partially offset by the optimization of testing workflows that resulted in improvements in costs per test.
In addition, our Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. We provide development services to enable therapeutic clinical trials, the validation of life sciences tools and diagnostics, and the discovery, development, and commercialization of diagnostics.
Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. We provide development services to enable therapeutic clinical trials, the validation of life sciences tools and diagnostics, and the discovery, development, and commercialization of diagnostics.
Interest shall accrue on the difference between the payment schedule as agreed in the August 2021 amendment and the April 2022 amended payment schedule, at an aggregate per annum rate equal to 10%, with such interest to be payable quarterly on the following installment payment date.
Interest accrued on the difference between the payment schedule as agreed in the August 2021 amendment and the April 2022 amended payment schedule, at an aggregate per annum rate equal to 10%, with such interest to be payable quarterly on the following installment payment date.
On October 30, 2024, the Company entered into the Fourth Amendment to the Credit Agreement (the Fourth Amendment), whereby, subject to the terms and conditions of the Fourth Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending June 30, 2025 through and including the fiscal quarter ending December 31, 2027.
On October 30, 2024 (the Fourth Amendment Effective Date), the Company entered into the Fourth Amendment to the Credit Agreement (the Fourth Amendment) with Perceptive, whereby subject to the terms and conditions of the Fourth Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending June 30, 2025 through and including the fiscal quarter ending December 31, 2027.
We currently offer two tests that assess the risk of cancer in lung nodules and three tests that provide treatment guidance after a lung cancer diagnosis.
We currently offer two tests (Nodify Lung® tests) that assess the risk of cancer in lung nodules and three tests (IQLung® tests) that provide treatment guidance after a lung cancer diagnosis.
The interest expense for the year ended December 31, 2024 is primarily related to interest and amortization of debt issuance costs associated with the Perceptive Term Loan Facility of $7.0 million and interest associated with the contingent consideration of $1.1 million.
The interest expense for the year ended December 31, 2024 is 73 primarily related to interest and amortization of debt issuance costs associated with the Perceptive Term Loan Facility of $7.0 million as well as interest associated with the contingent consideration of $1.1 million.
Biodesix Diagnostic Services has been utilized by over 65 industry clients and academic partners. We continuously revisit our technology strategy and roadmap to integrate new technologies into our evolving offering, which ultimately support the addition of new service and product revenue offerings.
Biodesix Development Services have been utilized by over 65 industry clients and academic partners. We continuously revisit our technology strategy and roadmap to integrate new technologies into our evolving offering, which ultimately support the addition of new service and product revenue offerings.
Additionally, on February 28, 2025, the Company entered into a fifth amendment to the Perceptive Term Loan Facility, whereby, subject to the terms and conditions of the fifth amendment, the Tranche C Loan revenue milestone was eliminated and the Commitment Termination Date (as defined in the Credit Agreement) was extended, providing continued availability to the Tranche C Loan in an aggregate amount equal to $10.0 million through December 31, 2025.
On February 28, 2025 (the Fifth Amendment Effective Date), the Company entered into the Fifth Amendment to the Credit Agreement (the Fifth Amendment) with Perceptive, whereby subject to the terms and conditions of the Fifth Amendment, the Tranche C Loan revenue milestone was eliminated and the Commitment Termination Date (as defined in the Credit Agreement) was extended, providing continued availability to the Tranche C Loan in an aggregate amount equal to $10.0 million through December 31, 2025.
Loss on extinguishment of liabilities, net Loss on extinguishment of liabilities increased $0.2 million or 100% for the year ended December 31, 2024, compared to the same period in 2023. On April 22, 2024, the Company obtained consent from Perceptive and prepaid the July 1, 2024 contingent consideration Milestone Payment of $8.4 million to Indi.
Loss on extinguishment of liabilities, net Loss on extinguishment of liabilities decreased $0.2 million or 100% for the year ended December 31, 2025 compared to the same period in 2024. On April 22, 2024, the Company obtained consent from Perceptive and prepaid the July 1, 2024 contingent consideration milestone payment of $8.4 million to Integrated Diagnostics (Indi).
The other income, net for the year ended December 31, 2024 was comprised of $0.8 million of interest and other income, offset by approximately $0.7 million of deferred offering costs as a result of changes in the probability of our ability to fully utilize the LPC Facility prior to the termination date.
The other income, net for the year ended December 31, 2024 was comprised of $0.8 million of interest and other income, offset by the reduction of approximately $0.7 million of deferred offering costs as a result of changes in the probability of our ability to fully utilize the Lincoln Park Capital equity facility prior to the termination date.
We believe we are the only company to offer two commercial blood-based tests to help physicians reclassify risk of malignancy in patients with suspicious lung nodules. 69 Lung Cancer Treatment & Monitoring • GeneStrat ® ddPCR, GeneStrat NGS ® and VeriStrat ® tests, marketed as part of our IQLung™ testing strategy, are used following diagnosis of lung cancer to detect the presence of mutations in the tumor and the state of the patient’s immune system to help guide treatment decisions.
We believe we are the only company to offer two Medicare/Medicaid-covered commercial blood-based tests to help physicians classify risk of malignancy in patients with suspicious lung nodules. 67 Lung Cancer Treatment & Monitoring o GeneStrat ® ddPCR, GeneStrat NGS ® and VeriStrat ® tests, marketed as part of our IQLung® testing strategy, are used following diagnosis of lung cancer to detect the presence of mutations in the tumor and the state of the patient’s immune system to help guide treatment decisions.
Non-Operating Expenses Interest Expense and Interest Income For the years ended December 31, 2024 and December 31, 2023, interest expense consists of cash and non-cash interest from the Perceptive Term Loan Facility, contingent consideration, and changes in the fair value of our contingent consideration associated with the passage of time subsequent to the achievement of the gross margin target in the second quarter 2021.
For the year ended December 31, 2024, interest expense consists of cash and non-cash interest from the Perceptive Term Loan Facility, contingent consideration, and changes in the fair value of our contingent consideration associated with the passage of time subsequent to the achievement of the gross margin target in the second quarter 2021.
The increase in revenue for the year ended December 31, 2024 was primarily a result of delivering against our expanding book of business and securing new agreements. Operating Expenses Direct costs and expenses Direct costs and expenses related to revenue increased $2.6 million or 20% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
The increase in revenue for the year ended December 31, 2024 was primarily a result of delivering against our expanding book of business and securing new agreements. Operating Expenses Direct costs and expenses Direct costs and expenses related to revenue increased $1.1 million or 7% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
We believe that the test volume we receive from clinicians and biopharmaceutical companies are indicators of growth in each of these customer verticals.
We believe that the test volume we receive from clinicians and biopharmaceutical companies are indicators of growth in each of these business lines.
For example, we believe our multi-omic data including genomic and proteomic 71 data, in combination with clinical outcomes or claims data, has revenue-generating potential, including for novel target identification and companion diagnostic discovery and development. • Motivating and expanding our field sales force and customer support team.
For example, we believe our multi-omic data including genomic and proteomic data, in combination with clinical outcomes or claims data, has revenue-generating potential, including for novel target identification and companion diagnostic discovery and development. • Motivating and expanding our field sales force and customer support team. Our field sales force is the primary point of contact in the clinical setting.
Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as expense in the period in which the related goods are received or services are rendered.
Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as expense in the period in which the related goods are received or services are rendered. Costs to develop our technology capabilities are recorded as research and development.
While our biopharmaceutical discovery, diagnostic development and testing revenue continues to grow, it is important to note that we benefit greatly from these partnerships in many ways that expand beyond revenue. We are continuously expanding our knowledge and biological understanding of multiple diseases and the rapidly evolving treatment landscape.
While our Development Services revenue continues to grow, it is important to note that we benefit from these partnerships in ways that expand beyond revenue. We are continuously expanding our knowledge and biological understanding of multiple diseases and the rapidly evolving treatment and regulatory approval landscape.
Lung Diagnostic Testing revenue increased $19.5 million or 43% for the year ended December 31, 2024 compared to the same period in 2023.
Lung Diagnostic Testing revenue increased $14.5 million or 22% for the year ended December 31, 2025 compared to the same period in 2024.
Cash Flows The following summarizes our cash flows for the periods indicated (in thousands): Year Ended December 31, 2024 2023 Net cash flows (used in) provided by : Operating activities $ (48,649 ) $ (22,870 ) Investing activities (3,440 ) (23,062 ) Financing activities 52,050 29,129 Net decrease in cash and cash equivalents and restricted cash $ (39 ) $ (16,803 ) Our cash flows resulted in a net decrease in cash and cash equivalents and restricted cash of $39 thousand during the year ended December 31, 2024 as compared to the net decrease in cash of $16.8 million for the year ended December 31, 2023.
Cash Flows The following summarizes our cash flows for the periods indicated (in thousands): Year Ended December 31, 2025 2024 Net cash flows (used in) provided by: Operating activities $ (23,271 ) $ (48,649 ) Investing activities (403 ) (3,440 ) Financing activities 16,417 52,050 Net decrease in cash and cash equivalents and restricted cash $ (7,257 ) $ (39 ) Our cash flows resulted in a net decrease in cash and cash equivalents and restricted cash of $7.3 million during the year ended December 31, 2025 as compared to the net decrease in cash of $39 thousand for the year ended December 31, 2024.
Customer mix for our tests has the potential to significantly impact our results of operations, as the average selling price for biopharmaceutical sample testing is currently significantly greater than our average selling price for clinical tests since we are not a contracted provider for, or our tests are not covered by all clinical patients’ insurance.
Customer mix stemming from our two business lines has the potential to significantly impact our results of operations, as the average selling price for biopharmaceutical sample testing is currently significantly higher than our average selling price for clinical tests since our tests are not covered by all clinical patients’ insurance.
In connection with the Tranche B draw, the Company remeasured the Tranche B Warrants through the Tranche B Borrowing Date and recorded the change in fair value through the statement of operations, and subsequently, reclassified the fair value to additional paid-in capital.
In connection with the Tranche C draw, the Company remeasured the Tranche C Warrants through the Tranche C borrowing date and recorded a loss of $0.3 million as a change in fair value of warrant liability through the statement of operations and, subsequently, reclassified the fair value to additional paid-in capital.
Other income, net During the year ended December 31, 2024, the Company recorded other income, net of $0.1 million.
Other income, net During the year ended December 31, 2025, the Company recorded other income, net of $0.6 million primarily related to interest and other income. During the year ended December 31, 2024, the Company recorded other income, net of $0.1 million.
Liquidity and Capital Resources We are an emerging growth company and, as such, have yet to generate positive cash flows from operations. We have funded our operations to date principally from net proceeds from the sale of our common stock, the sale of convertible preferred stock, revenue from Lung Diagnostic Testing and Development Services, and the incurrence of indebtedness.
Liquidity and Capital Resources Thus far in our operating history, we have yet to generate annual positive cash flows from operations. We have funded our operations to date principally from net proceeds from the sale of our common stock, the sale of convertible preferred stock, revenue from diagnostic testing and services, and the incurrence of indebtedness.
Our clinical research has resulted in approximately 90 peer-reviewed publications for our tests. In addition to clinical studies, we are collaborating with investigators from multiple academic cancer centers.
Through December 31, 2025, the study has accrued over 1,500 patients. Our clinical research has resulted in over 90 peer-reviewed publications for our tests. In addition to clinical studies, we are collaborating with investigators from multiple academic cancer centers.
As a result of prepaying the Milestone Payment, the Company performed a fair value analysis through April 22, 2024 and recorded a loss on early extinguishment of $0.2 million. Change in fair value of warrant liability, net During the year ended December 31, 2024, the Company recorded no change in fair value of warrant liability in the statements of operations.
As a result of prepaying the milestone payment, the Company performed a fair value analysis through April 22, 2024 and recorded a loss on early extinguishment of $0.2 million.
The interest expense for the year ended December 31, 2023 is primarily related to interest and amortization of debt issuance costs associated with the Perceptive Term Loan Facility of $5.5 million and interest associated with the contingent consideration of $3.9 million.
Non-Operating Expenses Interest expense Interest expense decreased $0.5 million or 7% for the year ended December 31, 2025 compared to the year ended December 31, 2024. The interest expense for the year ended December 31, 2025 is primarily related to interest and amortization of debt issuance costs associated with the Perceptive Term Loan Facility of $7.5 million.
The increase for the year ended December 31, 2024 compared to the same period in 2023 is due to an increase of $20.7 million in the Nodify Lung Nodule Risk Assessment testing strategy driven by an increase in tests delivered, partially offset by a $1.1 million decrease in the IQLung testing strategy as a result of a decrease in tests delivered as our sales efforts continue to focus on Nodify CDT and XL2 tests.
The increase for the year ended December 31, 2025 compared to the same period in 2024 was due to an increase of $15.3 million in the Nodify Lung Nodule Risk Assessment testing strategy driven by an increase in tests delivered and improvements in average revenue per test as our sales efforts continued to focus on Nodify CDT and XL2 tests.
The following table summarizes our external and internal costs for the years ended December 31, 2024 and 2023 (in thousands, except percentages): Year Ended December 31, Change 2024 2023 $ % External expenses: Clinical trials and associated costs $ 1,180 $ 1,663 $ (483 ) (29 )% Other external costs 2,778 2,822 (44 ) (2 )% Total external costs 3,958 4,485 (527 ) (12 )% Internal expenses 5,601 5,503 98 2 % Total research and development expenses $ 9,559 $ 9,988 $ (429 ) (4 )% Sales, marketing, general and administrative Sales, marketing, general and administrative expenses increased $13.1 million or 19% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
The following table summarizes our external and internal costs for the years ended December 31, 2025 and 2024 (in thousands, except percentages): Year Ended December 31, Change 2025 2024 $ % External expenses: Clinical trials and associated costs $ 1,730 $ 1,180 $ 550 47 % Other external costs 2,954 2,778 176 6 % Total external costs 4,684 3,958 726 18 % Internal expenses 7,317 5,601 1,716 31 % Total research and development expenses $ 12,001 $ 9,559 $ 2,442 26 % Sales, marketing, general and administrative Sales, marketing, general and administrative expenses increased $7.1 million or 9% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
As our services revenue grows, an increasing portion of research and development dollars are expected to be allocated to cost of services for biopharmaceutical service contracts.
We expect our research and development expenses to increase as we continue to innovate and develop additional products and expand our data management resources. As our services revenue grows, an increasing portion of research and development dollars are expected 71 to be allocated to cost of services for biopharmaceutical service contracts.
Our revenue, business opportunities and growth depend in part on our ability to attract new biopharmaceutical customers and to maintain and expand relationships with existing biopharmaceutical customers. We expect to increase our sales and marketing expenses in furtherance of this as we continue to develop these relationships, and we expect to support a growing number of investigations and clinical trials.
We expect to increase our sales and marketing expenses in furtherance of this as we continue to develop these relationships, and we expect to support a growing number of investigations and clinical trials.
Results of Operations The following table sets forth the significant components of our results of operations for the periods presented (in thousands, except percentages): Year Ended December 31, Change 2024 2023 $ % Revenues $ 71,323 $ 49,087 $ 22,236 45 % Operating expenses Direct costs and expenses 15,573 13,010 2,563 20 % Research and development 9,559 9,988 (429 ) (4 )% Sales, marketing, general and administrative 80,451 67,387 13,064 19 % Impairment loss on intangible assets 238 44 194 441 % Total operating expenses 105,821 90,429 15,392 17 % Loss from operations (34,498 ) (41,342 ) 6,844 17 % Other (expense) income Interest expense (8,258 ) (9,536 ) 1,278 13 % Loss on extinguishment of liabilities (248 ) — (248 ) (100 )% Change in fair value of warrant liability, net — (1,274 ) 1,274 100 % Other income, net 73 6 67 1,117 % Total other expense (8,433 ) (10,804 ) 2,371 22 % Net loss $ (42,931 ) $ (52,146 ) $ 9,215 18 % Share-based compensation (1) $ 6,638 $ 5,373 $ 1,265 24 % (1) Amounts represent share-based compensation expense reported in the Company’s results of operations above. 74 Revenues We generate revenue by providing laboratory testing of our diagnostic tests and services.
Results of Operations The following table sets forth the significant components of our results of operations for the periods presented (in thousands, except percentages): Year Ended December 31, Change 2025 2024 $ % Revenues $ 88,499 $ 71,323 $ 17,176 24 % Operating expenses Direct costs and expenses 16,719 15,573 1,146 7 % Research and development 12,001 9,559 2,442 26 % Sales, marketing, general and administrative 87,545 80,451 7,094 9 % Impairment loss on intangible assets 107 238 (131 ) (55 )% Total operating expenses 116,372 105,821 10,551 10 % Loss from operations (27,873 ) (34,498 ) 6,625 19 % Other (expense) income Interest expense (7,716 ) (8,258 ) 542 7 % Loss on extinguishment of liabilities — (248 ) 248 100 % Change in fair value of warrant liability, net (280 ) — (280 ) (100 )% Other income, net 604 73 531 727 % Total other expense (7,392 ) (8,433 ) 1,041 12 % Net loss $ (35,265 ) $ (42,931 ) $ 7,666 18 % Share-based compensation (1) $ 4,139 $ 6,638 $ (2,499 ) (38 )% (1) Amounts represent share-based compensation expense reported in the Company’s results of operations above. 72 Revenues We generate revenue by providing laboratory testing of our diagnostic tests and services.
This is partially offset by a year-over-year decrease in net loss from operations of $9.2 million. Net cash used in investing activities during the year ended December 31, 2024 totaled $3.4 million, a decrease of $19.6 million compared to the same period in 2023.
This is partially offset by a change in net working capital for the timing of cash receipts from customers and payments to vendors of $1.2 million. Net cash used in investing activities during the year ended December 31, 2025 totaled $0.4 million, a decrease of $3.0 million compared to the same period in 2024.
While each of these areas present significant opportunities for us, they also pose significant risks and challenges that we must address. See Part I, Item 1A. “Risk Factors” for more information.
Additionally, we plan to invest in the marketing and customer support teams to continue to provide the field sales force with the resources to be successful. While each of these areas present significant opportunities for us, they also pose significant risks and challenges that we must address. See Part I, Item 1A. “Risk Factors” for more information.
The net cash provided by financing activities for the year ended December 31, 2023 primarily resulted from $28.0 million net proceeds from the issuance of common stock, $10.0 million net proceeds from the issuance of Tranche B under the Perceptive Term Loan Facility, and $0.7 million in proceeds from the issuance of common stock under the ESPP and exercise of stock options.
The net cash provided by financing activities for the year ended December 31, 2025 primarily resulted from $10.0 million in proceeds from the issuance of Tranche C under the Perceptive Term Loan Facility, $7.3 million in proceeds from the issuance of common stock under our ATM facility, and $0.5 million in proceeds from our ESPP, partially offset by payments of $0.8 million associated with our finance lease obligations and $0.5 million in equity financing costs.
Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
These services are generally completed upon the delivery of testing results, or other contractually defined milestone(s), to the customer, which is considered the performance obligation. Customers for these services are typically large pharmaceutical companies where collectability is reasonably assured and therefore revenue is accrued upon completion of the performance obligations.
The performance obligations and related revenue for these sales is defined by a written agreement between us and our customer. These services are generally completed upon the delivery of testing results, or other contractually defined milestone(s), to the customer, which is considered the performance obligation.
Recent Accounting Pronouncements See Note 3 to our financial statements in Item 8 of this Annual Report on Form 10-K. 79 Implications of Being an Emerging Growth Company and Smaller Reporting Company We are an “emerging growth company” within the meaning of the Jumpstart Our Business Startups Act (JOBS Act).
Recent Accounting Pronouncements See Note 3 to our financial statements in Item 8 of this Annual Report on Form 10-K. 76 Implications of Being a Smaller Reporting Company We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.
On September 30, 2024, the Company obtained consent from Perceptive and prepaid the October 1, 2024 exit fee of $6.1 million to Indi. The Company has no remaining obligations to Indi.
The exit fee was paid on September 30, 2024, and the Company has no remaining obligations to Indi.
For the year ended December 31, 2024, net cash used in operating activities totaled $48.6 million, an increase of approximately $25.8 million compared to the same period in 2023 primarily due to unfavorable changes in net working capital of $33.0 million, which includes an increase of $20.7 million in payments made for contingent consideration and an $18.3 million decrease in tenant improvement allowances received for capital expenditures and leasehold improvements related to the CVP Lease.
For the year ended December 31, 2025, net cash used in operating activities totaled $23.3 million, a decrease of approximately $25.4 million compared to the same period in 2024 primarily due to favorable changes in net working capital of $22.0 million, which includes a decrease of $23.2 million in payments made for contingent consideration.
Our revenues for the periods indicated were as follows (in thousands, except percentages): Year Ended December 31, Change 2024 2023 $ % Revenues Lung Diagnostic Testing 64,708 45,192 19,516 43 % Development Services 6,615 3,895 2,720 70 % Total revenues $ 71,323 $ 49,087 $ 22,236 45 % Total revenue increased $22.2 million or 45% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
Our revenues for the periods indicated were as follows (in thousands, except percentages): Year Ended December 31, Change 2025 2024 $ % Revenues Diagnostic Tests 79,197 64,708 14,489 22 % Development Services 9,302 6,615 2,687 41 % Total revenues $ 88,499 $ 71,323 $ 17,176 24 % Total revenue increased $17.2 million or 24% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
The Tranche C loan had a commitment date through September 30, 2024 and, as of that date, the Company did not exercise its ability to draw the Tranche C loan.
The Tranche C loan had a prior commitment date through September 30, 2024 and, as of that date, the Company did not exercise its ability to draw the Tranche C loan (see below for further details related to the Fifth Amendment). On April 9, 2024, the Company closed an underwritten offering of common stock and a concurrent private placement.
We determine the transaction price related to our contracts by considering the nature of the payer, test type, the historical amount of time until payment by a payer and historical price concessions granted to groups of customers. 72 Development Services Development Services revenue is generated from the delivery of our on-market tests, pipeline tests, custom diagnostic testing, and other scientific services for a purpose as defined by any individual customer.
Development Services Development Services revenue is generated from the delivery of our on-market tests, pipeline tests, custom diagnostic testing, and other scientific services from contracts and business agreements with other diagnostic and life sciences tool customers for a purpose as defined by the individual customer.
The ORACLE study officially closed on May 28, 2024. The ALTITUDE study is a randomized control study, launched during the fourth quarter 2020, seeking to further demonstrate the utility of the Nodify CDT and XL2 tests.
The ALTITUDE study is a randomized control study, launched during the fourth quarter 2020, seeking to further demonstrate the utility of the Nodify CDT and XL2 tests. Patient enrollment requirements were reached in July 2025. All study participants are in two-year follow-up.
Our field sales force is the primary point of contact in the clinical setting. These representatives of the Company must cover expansive geographic regions which limits their time for interaction and education of our products in the clinical setting.
These representatives of the Company must cover expansive geographic regions which limits their time for interaction and education of our products in the clinical setting. We plan to continue investing in the field sales force through select expansion and provide them with tools that maximize their education and selling efforts in order to 69 achieve greater returns.
These proceeds were partially offset by milestone payments to Indi of $8.6 million. 78 Contractual Obligations and Commitments The following table summarizes our non-cancelable contractual obligations and commitments as of December 31, 2024 (in thousands): Payments due by period (1) Total Less than 1 year 1 to 3 years 4 to 5 years More than 5 years Borrowings and interest (2) $ 55,800 $ 5,433 $ 50,367 $ — $ — Operating lease obligations 44,079 3,580 8,235 8,394 23,870 Finance lease obligations 1,407 758 649 — — Total $ 101,286 $ 9,771 $ 59,251 $ 8,394 $ 23,870 (1) Royalty payments that we may owe are not included as the amount and timing of such payments is uncertain.
The net cash provided by financing activities for the year ended December 31, 2024 primarily resulted from $51.3 million in net proceeds from the issuance of common stock from an underwritten offering of common stock and a concurrent private placement and $0.6 million from the issuance of common stock under the ESPP. 75 Contractual Obligations and Commitments The following table summarizes our non-cancelable contractual obligations and commitments as of December 31, 2025 (in thousands): Payments due by period (1) Total Less than 1 year 1 to 3 years 4 to 5 years More than 5 years Borrowings and interest (2) $ 62,335 $ 6,444 $ 55,891 $ — $ — Operating lease obligations 41,323 4,165 8,692 8,935 19,531 Finance lease obligations 2,173 1,134 824 215 — Total $ 105,831 $ 11,743 $ 65,407 $ 9,150 $ 19,531 (1) Royalty payments that we may owe are not included as the amount and timing of such payments is uncertain.
Net cash provided by financing activities during the year ended December 31, 2024 totaled $52.1 million, an increase of $22.9 million compared to the same period in 2023.
The decrease in net cash used in investing activities was primarily due to decreases in purchases of property and equipment and capital expenditures. Net cash provided by financing activities during the year ended December 31, 2025 totaled $16.4 million, a decrease of $35.6 million compared to the same period in 2024.
As of December 31, 2024, the Company had remaining available capacity for share issuances of up to $46.9 million under the LPC Facility, subject to the restrictions and limitations of the underlying facility. Effective February 5, 2025, the Company terminated the LPC Facility.
As of December 31, 2025, the Company had remaining available capacity for share issuances of up to $42.7 million under the 2024 ATM Program, subject to the restrictions and limitations of the facility, as well as volume limitations under applicable SEC rules and regulations that may limit the availability of the 2024 ATM Program as a source of funding, depending on current public float.
On April 9, 2024, the Company closed an underwritten offering of common stock and a concurrent private placement. Collectively, the Company raised net proceeds of approximately $51.3 million (the April 2024 Offering).
Collectively, the Company raised net proceeds of approximately $51.3 million.
Research and development Research and development expenses decreased $0.4 million or 4% for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease in cost was primarily a result of a decrease in external costs associated with clinical trials and data acquisition costs.
Research and development Research and development expenses increased $2.4 million or 26% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
The increase was driven primarily by increases in employee compensation and benefits associated with an increase in headcount and variable compensation as well as increases in non-employee costs associated with increased spending on various sales meetings and sales fulfillment during 2024 as compared to 2023.
The increase in costs was primarily due to an increase in internal expenses associated with employee compensation and benefit costs resulting from an increase in headcount and variable compensation as well as an increase in external costs associated with clinical trials.
On February 29, 2024 (the Third Amendment Effective Date), the Company entered into the Third Amendment to the Credit Agreement (the Third Amendment) with Perceptive as lender and administrative agent and the Company, as borrower, whereby subject to the terms and conditions of the Third Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending March 31, 2024 through and including the fiscal quarter ending December 31, 2025.
Change in fair value of warrant liability, net On February 28, 2025, the Company entered into the Fifth Amendment to the Credit Agreement with Perceptive, whereby subject to the terms and conditions of the Fifth Amendment, the Tranche C Loan Commitment Termination Date was extended, providing continued availability to the Tranche C Loan through December 31, 2025.
The Company’s Lung Diagnostic Testing sales efforts continued to gain momentum during the year ended December 31, 2024 as the number of tests delivered reached the highest in Company history for eight consecutive quarters. Development Services revenue increased $2.7 million or 70% for the year ended December 31, 2024 compared to the same period in 2023.
This increase was partially offset by a $0.8 million decrease in the IQLung testing strategy sales. Development Services revenue increased $2.7 million or 41% for the year ended December 31, 2025 compared to the same period in 2024.
Revenue derived from services is often unpredictable and can cause significant swings in our overall net revenue line from quarter to quarter. In addition, Development Services also include amounts derived from licensing our digital sequencing technologies to our international laboratory partners.
Customers for these services are typically mid-size to large pharmaceutical companies where collectability is reasonably assured and therefore revenue is accrued upon completion of the performance obligations. Revenue derived from services is often unpredictable and can cause significant swings in our overall net revenue line from quarter to quarter.
Removed
On July 6, 2023, the Company announced that the Centers for Medicare & Medicaid Services (CMS) has designated the Nodify CDT Test as an Advanced Diagnostic Laboratory Test (ADLT) effective June 30, 2023. Obtaining ADLT status is a recognition that the Nodify CDT test meets the stringent criteria established under the Protecting Access to Medicare Act of 2014.
Added
In addition, payers who were previously either not covering or paying a reduced rate for the tests may decide in the future to start or restart reimbursing for one or more of our tests.
Removed
ADLT status is reserved for innovative tests with Medicare coverage that provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests. Nodify CDT joins our Nodify XL2 and VeriStrat tests with the ADLT designation. • Investment in clinical studies and product innovation to support growth.
Added
In the three months ending September 30, 2025, a major third party commercial payer who had previously stopped reimbursing us for certain of our tests began reimbursing claims for use of the tests, which contributed to an increase in average revenue per test in the quarter.
Removed
On July 12, 2023, we announced the prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test) achieved the primary endpoint of a statistically significant change in the proportion of benign lung nodules managed by Nodify XL2 experiencing invasive procedures.
Added
While we currently expect this trend to continue, there is no guarantee of future reimbursement performance from this particular payer or any other payer. • Investment in clinical studies and product innovation to support growth.
Removed
The ORACLE study showed patients with benign nodules managed with the Nodify XL2 test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group.
Added
Our revenue, business opportunities and growth depend in part on our ability to attract new Development Services including biopharmaceutical customers and to maintain and expand relationships with existing biopharmaceutical customers.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

3 edited+0 added−0 removed4 unchanged
Biggest changeAs of December 31, 2024, a hypothetical 100 basis point increase in interest rates would have an estimated $0.4 million impact per year on our financial position and results of operations, based on the current Perceptive Term Loan principal remaining outstanding through maturity. Item 8. Financial Statement s and Supplementary Data.
Biggest changeAs of December 31, 2025, a hypothetical 100 basis point increase in interest rates would have an estimated $0.5 million impact per year on our financial position and results of operations, based on the current Perceptive Term Loan principal remaining outstanding through maturity. Item 8. Financial Statement s and Supplementary Data.
The financial statements and supplementary data are as set forth in the index to the financial statements on page F-1. Item 9. Changes in and Disagreements with Accou ntants on Accounting and Financial Disclosure. None. 80
The financial statements and supplementary data are as set forth in the index to the financial statements on page F-1. Item 9. Changes in and Disagreements with Accou ntants on Accounting and Financial Disclosure. None.
As of December 31, 2024, we had $40.0 million outstanding on the Perceptive Term Loan Facility which has an annual rate equal to the greater of (a) forward-looking one-month term SOFR as posted by CME Group Inc. and (b) 3.0% per annum, plus an applicable margin of 9.0%.
As of December 31, 2025, we had $50.0 million outstanding on the Perceptive Term Loan Facility which has an annual rate equal to the greater of (a) forward-looking one-month term SOFR as posted by CME Group Inc. and (b) 3.0% per annum, plus an applicable margin of 9.0%.

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