BDSX 10-K & 10-Q changes, risk factors and insider trading

For the years ended December 31, 20242025 and 2023,2024, Medicare reimbursed 39%32% and 43%,39%, respectively, of our total revenue to us. For the years ended December 31, 2024 and 2023, one customer accounted for 7% and 10%, respectively, of our total revenue. There are risks whenever a large percentage of total revenues are concentrated with a limited number of payers and customers. It is not possible for us to predict the level of demand for our diagnostic tests and services that will be generated by any of these customers in the future. In addition, revenues from these larger customers may fluctuate from time to time based on these customers’ business needs, the timing of which may be affected by market conditions or other factors outside of our control. These payers and customers could also potentially pressure us to reduce the prices we charge for our diagnostic tests and services, which could have an adverse effect on our margins and financial position and could negatively affect our revenues and results of operations. 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.

We are exposed to significant future payments and other obligations associated with our acquisition of Freenome (formerly Oncimmune, U.S.A., and may not realize the advantages we expect from this acquisition.U.S.A).

Our acquisition may require us to incur non-recurring and other charges, increase our near and long-term expenditures, or disrupt our management and business. We cannot be certain that, following the realization of this acquisition, we will achieve the revenue or specific net income that justifies our entry into it. This could delay our sales and marketing efforts, which would harm our business prospects, financial condition and results of operations.

In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Code) a corporation that undergoes an ownership change, generally defined as a greater than 50% change by value in its equity ownership by certain shareholders over a three-year period, is subject to limitations on its ability to utilize its pre-change net operating losses (NOLs) and its research and development credit carryforwards to offset future taxable income. The applicable rules generally operate by focusing on changes in ownership among stockholders considered by the rules as owning, directly or indirectly, 5% or more of the stock of a company, as well as changes in ownership arising from new issuances of stock by the company. We believe that our NOLs are currently not subject to limitation under these rules. However, ifIf 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. In addition, our ability to deduct net interest expense may be limited if we have insufficient taxable income for the year during which the interest is incurred, and any carryovers of such disallowed interest would be subject to the limitation rules similar to those applicable to NOLs and other attributes. 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.

On November 16, 2022 (Closing Date),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. The Perceptive Term Loan Facility provides for an “interest-only” period during the term of the loan with principal due at the maturity date, which will be November 21, 2027.

The Perceptive Term Loan Facility contains customary affirmative and negative covenants for a loan, requires us to comply with a minimum cash requirement covenant, and has a trailing twelve month net revenue requirement. Failure to comply with the covenants and loan requirements may result in an event of default. 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.

We willmay need to raise additional capital to fund our existing operations, develop our platform, commercialize new diagnostic tests or expand our operations.

We willmay 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:

Moreover, increasing efforts by governmental and third-party payers, in the United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement for newly cleared, authorized, certified or approved devices and medicines and, as a result, they may not cover or provide adequate payment for our clinical diagnostics to be sold by us or our collaborators. For example, in May 2018 the United States government released a “blueprint,” or plan, to reduce the cost of drugs. This blueprint contains certain measures that HHS has been working to implement, although it is possible that HHS’s regulatory priorities may change under the Biden administration. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, which are, in some cases, designed to encourage importation from other countries and bulk purchasing.

There have been judicial challenges to certain aspects of the ACA, as well as efforts by the Trump administration and Congress to repeal, replace or alter the implementation of certain aspects of the ACA. For example, as part of the TCJA, Congress eliminated the tax penalty, starting January 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance. The Further Consolidated Appropriations Act of 2020, Pub. L. No. 116-94, signed into law December 20, 2019, fully repealed the ACA’s “Cadillac Tax” on certain high-cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share (repeal effective in 2021), and the medical device excise tax on non-exempt medical devices. At the end of 2025, the ACA’s enhanced premium tax credit expired, increasing premium payments for marketplace coverage.

The Biden administration took steps to strengthen the ACA and focus on reducing the cost of healthcare. We face uncertainties that might result from modifications or repeal of any of the provisions of the ACA, including as a result of current and future executive orders and legislative actions. The impact of those changes on us and potential effect on the medical device industry as a whole is currently unknown. Any changes to the ACA are likely to have an impact on our results of operations, and may negatively affect our business, financial condition and results of operations. We 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.

The FDA has recently increased itspays attention to marketing of pharmacogenetic tests. For example, in late 2018, the FDA issued a safety communication regarding genetic laboratory tests with claims to predict a patient’s response to specific medications that have not been reviewed by the FDA and may not be supported by clinical evidence. Among other tests, the FDA notice cited genetic tests that claim results can be used to help physicians identify which antidepressant medication would have increased effectiveness or side effects compared to other antidepressant medications. 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.

If Congress were to enact legislation providing the FDA’sFDA Maywith 6,jurisdiction 2024over Final Rule to end enforcement discretion is implementedLDTs, or if the FDA otherwise issues new rules, policies, or guidance, due to new legislation or on its own accord, or otherwise determines that our tests are not subject to enforcement discretion,LDTs, our tests may become subject to FDA requirements, including pre-market review. If this were to happen, it may impact our marketing practices relating to the relevant tests, which in turn may have an adverse impact on our business, financial condition and results of operations.

Pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. AlthoughHistorically, 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 exercisedclaimed to exercise enforcement discretion and is currently not otherwise regulatingover most tests developed and performed within a single high complexity CLIA-certified laboratory. 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. However on March 31, 2025, the U.S. District Court for the Eastern District of Texas struck down the FDA’s final rule, concluding that it exceeds FDA’s statutory jurisdiction, authority, or limitations. The final rule was vacated and remanded to FDA for further consideration based on the opinion, with the court stating that “[t]here is no likelihood that FDA can justify its decision on remand, given that the final rule exceeds its authority under the FDCA.” The government did not file an appeal to the decision, and in September 2025 FDA rescinded the final rule.

Even if the obligations that could be imposed by the final rule do not become applicable to our tests, Congress could take action to amend the law to change the current regulatory framework for in vitro diagnostics and LDTs to require premarket FDA review of LDTs and other regulatory requirements. New requirements, whether imposed through legislation or administratively, could result in delay or additional expense in offering our tests and tests that we may develop in the future. Moreover, failure to comply with applicable requirements under the relevant timeframes could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial enforcement actions, which in turn may have an adverse impact on our business, financial condition, and results of operations.

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.CLIA.

While we believe that we are currently in material compliance with applicable laws and regulations, it is possible that the FDA, or other regulatory agencies, would not agree with our determinations. If our products or services became become subject to premarket submission and other FDA requirements, we would need to comply with the applicable regulations or face significant civil and criminal penalties. 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. Exposure to these additional regulatory requirements would also affect our business, financial condition and results of operations.

Any medical device that we manufacture, including those for which we obtain regulatory clearance or approval or certification, and the manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for such diagnostic test, will be subject to continued regulatory review, oversight, and periodic inspections by the FDA and other domestic and foreign regulatory bodies or conformity assessment bodies. In particular, we and our suppliers may be required to comply with the FDA’s QSRregulatory requirements for quality systems and other current good manufacturing practices of medical devices (QSR codified at 21 C.F.R.CFR §Part 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. Regulatory bodies, such as the FDA, and conformity assessment bodies enforce thethese QSRmanufacturing and otherquality management-related regulations through periodic inspections and audits. 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:

In addition, we are required to conduct surveillance to monitor the safety or effectiveness of our diagnostic tests, and we must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our diagnostic tests. 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,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.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. For example, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act introduced in Congress would codifyhave 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. The VALID Act was not passed into law, but similar such proposals may be introduced in the future.

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 identifyingpersonal information, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information. Failure by us or our third-party vendors, collaborators, contractors and consultants to comply with any of these laws and regulations could result in notification obligations or enforcement actions against us, which could result in fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects. These laws, rules and regulations evolve frequently and their scope may continually change, through new legislation, amendments to existing legislation and changes in enforcement, and may be inconsistent from one jurisdiction to another. The interpretation and application of consumer, health-related and data protection laws, especially with respect to genetic samples and data, in the United States, the EU and elsewhere, are often uncertain, contradictory and in flux. As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future.

In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, 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.

Domestic laws in this area are complex and developing rapidly. Many state legislatures have adopted legislation relating to privacy, data securityprivacy and data breaches. Laws in all 50 states require businesses to provide notice to customers whose personally identifiable information has been disclosed as a result of a data breach.security. The laws aremay notbe consistent,inconsistent, and compliance in the event of a widespread datacybersecurity breachincident ismay be costly. States are also frequently amending existing laws, requiring attention to frequently changing regulatory requirements. For example, California recently enacted the CCPA, which became effective on January 1, 2020. The CCPA, among other things,CCPA requires new disclosures to California consumers and affords such consumers new abilitiesrights to access and delete their personal information, opt-out of certain salesdisclosures of personal information and receive detailed information about how their personal information is used.collected, used, and disclosed. The CCPA provides for fines of up to $7,500 per violation, as well as a private right of action for data breaches that ishas expectedresulted toin increasean theuptick frequency ofin data breach litigation.litigation against companies generally. While the CCPA hasand alreadysimilar state laws have been amendedamended, multipleand times,more continue to be proposed, it is unclear how thisstate privacy legislation will be further modified or how it will be interpreted. Interpretations of the CCPA may continue to evolve with regulatory guidance and the CCPA continue to be amended, including through a ballot initiative, adopted by voters in November 2020, known as the California Privacy Rights Act, or CPRA. The CPRA imposes additional data protection obligations on companies doing business in California, including additional consumer rights, including regarding certain uses of sensitive data. It also creates a new California data protection agency - the California Privacy Protection Agency - specifically tasked to enforce the law, which may likely result in increased regulatory scrutiny of California businesses in the areas of data protection and security. The effects of thisstate comprehensive privacy legislation potentially are far-reaching, however,far-reaching and may require us to modify our data processing practices and policies and incur substantial compliance-related costs and expenses. The CCPA and other changes in state and federal laws or regulations relating to privacy, data protection and information security, particularly any new or modified laws or regulations that require enhanced protection of certain types of data or new obligations with regard to data retention, transfer or disclosure, could increase the cost of providing our offerings, require significant changes to our operations or even prevent us from providing certain offerings in jurisdictions in which we currently operate and in which we may operate in the future.

In addition, numerous state and federal laws and regulationsregulations, including HIPAA, govern the collection, dissemination, use, privacy, confidentiality, security, availability, integrity, and other processing of PHI and PII. These laws and regulations include HIPAA. HIPAA establishes a set of national privacy and security standards for the protection of protected health information (as defined in HIPAA, PHI) by health plans, healthcare clearinghouses and certain healthcare providers, referred to as covered entities (CE),CEs and the business associates (BA) with whom such covered entities contract for services. We are a CE under HIPAA when we are conducting our clinical trials. We are a CE with regard to our observational studies and clinical trials, and also a BA under HIPAA for certain other business activities, and we execute BA agreements with our clients.

HIPAA imposesprovides mandatoryfor penalties for certain violations. Penalties for violations of HIPAA and its implementing regulations start at $119 per violation and are subject to a cap of $1,785,651 for violations of the same standard in a single calendar year. However, a single breach incident can result in violations of multiple standards. HIPAA also authorizes state attorneys general to file suit on behalf of their residents. Courts may award damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create a private right of action allowing individuals to sue us in civil court for violations of HIPAA, its standards have been used as the basis for duty of care in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI.

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A), is provided to supplement the audited financial statements and the related notes in Part II - —Item 8 of this Annual Report on Form 10-K. We intend for this discussion to provide you with information that will assist you in understanding our financial statements, the changes in key items in those financial statements from year to year and the primary factors that accounted for those changes. Data for the years ended December 31, 20242025 and 20232024 has been derived from our audited financial statements included in this Annual Report on Form 10-K.

We are a leading diagnostic solutions companycompany, and our mission is to transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs. We envision a world where patient disease is conquered through the guidance of personalized diagnostics.

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. We believe that establishing a new standard of care utilizing personalized diagnostics requires aan deepextensive 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.

Our Biodesix Lung Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. We believe our diagnostic tests help healthcare providers meaningfully improve lung disease diagnosis, treatment, and monitoring as well as lower the overall healthcare cost by reducing the use of ineffective and unnecessary treatments and procedures. 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.

Nodify CDT® and Nodify XL2® tests, marketed as Nodify Lung® Nodule Risk Assessment, assess a suspicious lung nodule's risk of lung cancer to help identify the most appropriate treatment pathway. The Nodify CDT and XL2 tests have an established average turnaround time of one and five business days, respectively, from receipt of the blood sample, providing physicians with timely results to guide diagnostic planning. The Nodify CDT test is a blood-based test that detects the presence of seven autoantibodies associated with the presence of tumors. Elevated levels of the autoantibodies in patients with lung nodules indicate an increased risk of lung cancer to help identify patients that may benefit from timely intervention. The Nodify XL2 test is a blood-based proteomic test that evaluates the likelihood that a lung nodule is benign to help identify patients that may benefit from surveillance imaging. We believe we are the only company to offer two Medicare/Medicaid-covered commercial blood-based tests to help physicians reclassifyclassify risk of malignancy in patients with suspicious lung nodules.

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. The GeneStrat ddPCR tumor genomic profiling test and the VeriStrat immune profiling test have an established average turnaround time of two business days from receipt of the blood sample, and the GeneStrat NGS test has an established average turnaround time of three business days from receipt of the blood sample, providing physicians with timely results to facilitate treatment decisions. The GeneStrat ddPCR test evaluates the presence of actionable mutations in lung cancer. The test is covered independent of stage and can be used multiple times per patient to monitor changes in mutation status. The GeneStrat NGS test is a broad 52 gene panel, including guideline recommended mutations that help identify advanced stage patients eligible for targeted therapy or clinical trial enrollment. The VeriStrat test is a blood-based proteomic test that provides a personalized view of each patient’s immune response to their lung cancer.

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 DiagnosticDevelopment Services hashave been utilized by over 65 industry clients and academic partners.

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.

While our biopharmaceuticalDevelopment discovery, diagnostic development and testingServices 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 and regulatory approval landscape.

Testing volume and customer mix. Our revenues and costs are affected by the volume of testing and mix of customers from period to period. We evaluate both the volume of our commercial tests, or the number of tests that we perform for patients on behalf of clinicians, as well as tests for biopharmaceutical companies. Our performance depends on our ability to retain and broaden adoption with existing customers, as well as attract new customers. We believe that the test volume we receive from clinicians and biopharmaceutical companies are indicators of growth in each of these customerbusiness verticals.lines. Customer mix forstemming from our teststwo business lines has the potential to significantly impact our results of operations, as the average selling price for biopharmaceutical sample testing is currently significantly greaterhigher 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. We evaluate our average selling price for tests that are covered by Medicare, Medicare Advantage and commercial payers to understand the trends in reimbursement and apply those trends to our revenue recognition policies.

The ongoing INSIGHT study was designed to expand our clinical understanding of the predictive and prognostic value of the VeriStrat test. 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 2025.2026.

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.

On October 8, 2024, at the CHEST Annual Meeting, the Company presented the experience of healthcare providers using the Nodify Lung Nodule Risk Assessment in over 35,000 patients consecutively tested in a real-world clinical setting. The Company also announced a new clinical study, CLARIFY, that will collect patient outcomes and other clinical information on a subset of the patients featured in the CHEST presentation. CLARIFY is designed to confirm performance of the Nodify CDT and Nodify XL2 tests in diverse patient subgroups through a retrospective chart review of up to 4,000 patients that were tested in a real-world clinical setting. The study's intent is to expand the extensive evidence characterizing the validation and utility of Nodify Lung testing. Through December 31, 2025, the study has accrued over 1,500 patients.

Our clinical research has resulted in approximatelyover 90 peer-reviewed publications for our tests. In addition to clinical studies, we are collaborating with investigators from multiple academic cancer centers. On June 3, 2022, we announced the intent to develop a new novel molecular minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and the Company also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer. On March 25, 2024, we announced a new master collaborative research agreement (MCRA) with MSK under which the teams will collaborate on a development plan for diagnostic tests aimed at improving the treatment of cancer. Biodesix will utilize its array of genomics, proteomics, and data mining capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Bio-Rad will provide its industry-leading digital PCR assay technology in support of this important work. We believe these studies and collaborative arrangements are critical to gaining physician adoption and driving favorable coverage decisions by payers and expect our investments in research and development to increase. FurtherFurther, 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. 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. 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. If our relationships expand, we believe we may have opportunities to offer our platform for companion diagnostic development, novel target discovery and validation efforts, and to grow into other commercial opportunities. 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.

Lung Diagnostic TestingTest revenue of $17.2$25.1 million and $64.7$79.2 million for the fourth quarter and fiscal 2024,2025, respectively, an increase of 34%46% and 43%22% over the respective prior year comparable periods;periods. primarilyTest volumes were 18,000 and 62,600 for the fourth quarter and fiscal 2025, respectively, an increase of 23% and 15% over the prior year comparable periods. The increase in average revenue per test was driven by anadditional increasepayer coverage, improvements in totalrevenue testscycle deliveredmanagement, and approximately $1.0 million in collections from claims older than one year;

Development Services revenue of $3.2$3.6 million and $6.6$9.3 million for the fourth quarter and fiscal 2024,2025, respectively, an increase of 72%12% and 70%41% over the respective prior year comparable periodsperiods, a result of both delivering against the Company’s book of contracted business and securing new agreements;

IncludesTotal non-cash stock compensation expenserevenue of $1.3$28.8 million in Q4 and $6.6$88.5 million duringin fourth quarter and fiscal 2024, respectively,FY2025, an increase of 17%41% and 24% over the respective prior year comparable periodsperiods, with gross margin expanding 400bps to 83% in Q4 and 300bps to 81% for the full year;

NetIncludes lossnon-cash stock compensation expense of $8.3$1.1 million and $42.9$4.1 million forduring the fourth quarter and fiscal 2024,2025, respectively,a an improvementdecrease of 10%15% and 18%38% over the respective prior year comparable periods;

We derive our revenue from two sources: (i) Biodesix Lung Diagnostic TestingTests (Lung Diagnostic TestingTests), 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.

Lung Diagnostic TestingTests

Lung Diagnostic testTests 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 healthcare provider or third-party to which we contracted for services to be performed, which is considered the performance obligation. The fees for such services are billed either to a third party such as Medicare, medical facilities, commercial insurance payers, or to the patient. 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.

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 anythe individual customer. At times we collaborate with large biopharmaceutical companies in an attempt to discover biomarkers that would be helpful in their drug development or marketing. 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. 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.

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. These expenses consist primarily of salaries, commissions, bonuses, employee benefits, share-based compensation, and travel, as well as marketing and educational activitiesactivities, and allocated overhead expenses. We expect our sales and marketing expenses to increase in dollars as we expand our sales force, increase our presence within the United States, and increase our marketing activities to drive further awareness and adoption of our tests and our future products and services. These expenses, though expected to increase in dollars, are expected to decrease as a percentage of revenue in the long term, though they may fluctuate as a percentage of our revenues from period to period due to the timing and nature of these expenses.

For the yearsyear ended December 31, 20242025, interest expense primarily consists of cash and non-cash interest from the Perceptive Term Loan Facility. For the year ended December 31, 2023,2024, 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. Interest income, which is included in ‘Other income, net’ in the statements of operations consists of income earned on our cash and cash equivalents.

Lung Diagnostic Testing revenue increased $19.5$14.5 million or 43%22% for the year ended December 31, 20242025 compared to the same period in 2023.2024. The increase for the year ended December 31, 20242025 compared to the same period in 20232024 iswas due to an increase of $20.7$15.3 million in the Nodify Lung Nodule Risk Assessment testing strategy driven by an increase in tests delivered,delivered partiallyand offset by a $1.1 million decreaseimprovements in theaverage IQLungrevenue testingper strategy as a result of a decrease in tests deliveredtest as our sales efforts continuecontinued to focus on Nodify CDT and XL2 tests. TheThis Company’sincrease Lungwas Diagnosticpartially Testingoffset salesby effortsa continued$0.8 tomillion gaindecrease momentum duringin the yearIQLung endedtesting Decemberstrategy 31, 2024 as the number of tests delivered reached the highest in Company history for eight consecutive quarters.sales.

Research and development expenses decreasedincreased $0.4$2.4 million or 4%26% for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The decreaseincrease in costcosts was primarily adue resultto ofan aincrease decreasein 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 and data acquisition costs.trials.

Sales, marketing, general and administrative expenses increased $13.1$7.1 million or 19%9% for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The increase was driven primarily by increases in employee compensation and benefits associateddue withto anthe increaseplanned inexpansion headcountof andthe variablesales compensationteam to support Lung Diagnostic sales growth, as well as increasesto inenhance non-employeeBiodesix costs associated with increased spending on various sales meetingsawareness and salesdrive fulfillmentproduct during 2024 as compared to 2023. Of the $13.1 million increase, $2.6 million is associated with the increase in depreciation and amortization expense primarily related to the leasehold improvements in our new Louisville headquarters and laboratory.adoption.

Interest expense decreased $1.3$0.5 million or 13%7% for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. 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 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 andas well as interest associated with the contingent consideration of $1.1 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. The decrease in interest expense for the year ended December 31, 2024 was primarily related to the interest associated with the declining contingent consideration balance as the remaining Milestone Payments and final exit fee payment were made.

Loss on extinguishment of liabilities increaseddecreased $0.2 million or 100% for the year ended December 31, 2024,2025 compared to the same period in 2023.2024. On April 22, 2024, the Company obtained consent from Perceptive and prepaid the July 1, 2024 contingent consideration Milestonemilestone Paymentpayment of $8.4 million to Indi.Integrated Diagnostics (Indi). As a result of prepaying the Milestonemilestone Payment,payment, the Company performed a fair value analysis through April 22, 2024 and recorded a loss on early extinguishment of $0.2 million.

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. 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 LPCLincoln FacilityPark Capital equity facility prior to the termination date.

WeThus arefar anin emergingour growthoperating companyhistory, and, as such,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 Lungdiagnostic Diagnostic Testingtesting and Development Services,services, and the incurrence of indebtedness.

The Company amended the Indi APA agreement in April 2022 in which all parties agreed to restructure the Milestonemilestone Paymentspayments whereby the Company willwould 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. In addition, the Company agreed to an exit fee of approximately $6.1 million in October 2024. Interest shall accrueaccrued 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. OurThe abilityexit tofee makewas thesepaid payments is subject to ongoing compliance under the Perceptive Term Loan and commencing January 1, 2024, consent from Perceptive. On April 22, 2024, the Company obtained consent from Perceptive and prepaid the July 1, 2024 Milestone Payment of $8.4 million to Indi. Onon 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.

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 3,000,000150,000 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. 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). 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.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. Collectively, the Company raised net proceeds of approximately $51.3 million (the April 2024 Offering).million.

On October 30, 2024,2024 (the Fourth Amendment Effective Date), the Company entered into the Fourth Amendment to the Credit Agreement (the Fourth Amendment), whereby,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.

Biodesix, Inc. is referred to throughout this Quarterly Report on Form 10-Q for the period ended MarchJune 31,30, 2026 (Form 10-Q) as “we”, “us”, “our” or the “Company”.

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2025 (Form 10-K) and the Condensed Financial Statements as of MarchJune 31,30, 2026 and for the three and six months ended MarchJune 31,30, 2026 and 2025, included in Part I, Item 1 of this Quarterly Report on Form 10-Q, which provide additional information regarding our financial position, results of operations and cash flows. To the extent that the following MD&A contains statements which are not of a historical nature, such statements are forward-looking statements, which involve risks and uncertainties, including but not limited to those set forth under the caption “Special Note Regarding Forward-Looking Statements” and Item 1A. “Risk Factors” of Part II in this Quarterly Report on Form 10-Q and those discussed in our other filings with the Securities and Exchange Commission (SEC), including the risks described in Item 1A. “Risk Factors” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed on February 26, 2026.

The following MD&A discussion is provided to supplement the Condensed Financial Statements as of MarchJune 31,30, 2026 and 2025 and for the three and six months then ended included in Part I, Item 1 of this Quarterly Report on Form 10-Q. We intend for this discussion to provide you with information that will assist you in understanding our financial statements, the changes in key items in those financial statements from period to period, and the primary factors that accounted for those changes.

Data for the three and six months ended MarchJune 31,30, 2026 and 2025 has been derived from our unaudited condensed financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

On October 8, 2024, at the CHEST Annual Meeting, the Company presented the experience of healthcare providers using the Nodify Lung Nodule Risk Assessment in over 35,000 patients consecutively tested in a real-world clinical setting. The Company also announced a new clinical study, CLARIFY, that will collect patient outcomes and other clinical information on a subset of the patients featured in the CHEST presentation. CLARIFY is designed to confirm performance of the Nodify CDT and Nodify XL2 tests in diverse patient subgroups through a retrospective chart review of up to 4,000 patients that were tested in a real-world clinical setting. The study's intent is to expand the extensive evidence characterizing the validation and utility of Nodify Lung testing. Through MarchJune 31,30 2026, the study has accrued over 1,7001,900 patients.

Ability to attract new Development Services including biopharmaceutical and life sciences 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. 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 and life sciences 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. If our relationships expand, we believe we may have opportunities to offer our platform for companion diagnostic development, novel target discovery and validation efforts, and to grow into other commercial opportunities. 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. 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 achieve greater returns. 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,II, Item 1A. “Risk Factors” for more information.

FirstSecond Quarter 2026 Financial and Operational Highlights

The following were significant developments affecting our business, capital structure and liquidity during the three months ended MarchJune 31,30, 2026 as compared to the same period in 2025 unless otherwise noted:

Diagnostic Testing revenue was $22.3$25.4 million in the firstsecond quarter, representing 37% year-over-year42% growth, driven by a 29%38% increase in test volumes to 17,80020,900 and higher average revenue per test.test year-over-year. The improvement in average revenue per test was primarily attributable to expanded payer coverage and enhancementscontinued improvements to revenue cycle management;

Development Services revenue of $3.3$1.5 million in the firstsecond quarter 2026, representingas acompared 99%to increase$2.1 million in the prior year overperiod year,reflecting driventiming byof continuedproject execution on existing contractscompletion and therevenue additionrecognition. of newThe Development Services agreementspipeline is strong and supports our expectations for growth over the remainder of 2026;

Total revenue of $25.6$26.9 million in the firstsecond quarter 2026, an increase of 42%34% over the respective prior year comparable period;

Gross margin was 84%82% in the firstsecond quarter, including a one‑time200-basis recovery of $0.4 million related to previously paid sales and use taxes. Excluding this one‑time item, gross margin was 82%, representing a 300‑basis‑point improvement over the respective prior‑ year comparable period. MarginThe expansionCompany wascontinues to deliver strong gross margins driven by higher Diagnostic Testing volumes, improved average revenue per test, and continued optimization of laboratory workflows, resulting in a lower cost per test;

Operating expenses (excluding direct costs and expenses) of $27.6 million for the firstsecond quarter 2026, an increase of 18%7% over the respective prior year comparable period. Sales, marketing, and general administrative investment increased 19% to support the 42% revenue growth delivered in the first quarter. The Company expects continued operating leverage as our expanded sales team advancesgains alongexperience, theincreases productivity curveproductivity, and converts growing experience intodelivers sustained performance.performance;

Includes non-cash stock compensation expense of $1.1$0.8 million during the firstsecond quarter 2026, ana increasedecrease of 15%21% overversus the respective prior year comparable period;

Net loss of $7.8$7.3 million for the firstsecond quarter 2026, an improvement of 30%37% over the respective prior year comparable period;

Cash and cash equivalents of $25.6$30.0 million, an increase of 35%17% over the period ending DecemberMarch 31, 2025.2026. Change in cash included $16.8$6.5 million of at-the-market net proceeds, partially offset by the planned cash outflows that occur annually during the first quarter of the year.proceeds.

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 performance obligations and related revenue for these sales isare 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. Customers for these services are typically mid-sizemid-sized 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.

Cost of diagnostic testing generally consists of cost of materials, direct labor, including bonuses, employee benefits, share-based compensation, equipment and infrastructure expenses associated with acquiring and processing test samples, including sample accessioning, test performance, quality control analyses, charges to collect and transport samples; curation of test results for physicians; and in some cases, license or royalty fees due to third parties. Costs associated with performing our tests are recorded as the tests are processed regardless of whether revenue was recognized with respect to the tests. Infrastructure expenses include allocated depreciation of laboratory equipment, rent costs, amortization of leasehold improvements, and information technology costs. Royalties for licensed technology are calculated as a percentage of revenues generated using the associated technology and recorded as expense at the time the related revenue is recognized. One-time royalty payments related to signing license agreements or other milestones, such as issuance of new patents, are amortized to expense over the expected useful life of the patents. While we do not believe the technologies underlying these licenses are necessary to permit us to provide our tests, we do believe these technologies are potentially valuable and of possible strategic importance to us or our competitors. Under these license agreements, we are obligated to pay aggregate royalties ranging from 1% to 8% of sales in which the patents or know-how are used in the product or service sold, sometimes subject to minimum annual royalties or fees in certain agreements.

Research and development costs are expensed as incurred. Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as expenseexpenses 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.

For the three and six months ended MarchJune 31,30, 2026 and 2025 interest expense primarily consists of cash and non-cash interest from the Perceptive Term Loan Facility. Interest income, which is included in ‘Other income, net’ in the condensed statements of operationsoperations, consists of income earned on our cash and cash equivalents.

Total revenues increased $7.6$6.8 million, or 42%,34%, and $14.4 million, or 38%, for the three and six months ended MarchJune 31,30, 20262026, respectively, compared to the same periodperiods in 2025.

Diagnostic Tests revenue increased $6.0$7.5 million, or 37%,42%, and $13.4 million, or 39%, for the three and six months ended MarchJune 31,30, 20262026, respectively, compared to the same periodperiods in 2025. The increaseincreases isare primarily due to an increase of $6.1$7.3 million and $13.4 million, respectively, in the Nodify Lung Nodule Risk Assessment testing strategy driven by increases in tests delivered and improvements in average revenue per test as our sales efforts continue to focus on Nodify CDT and XL2 tests. This increase in revenue was partially offset by a $0.1 million decrease in the IQLung testing strategy.

Development Services revenue increaseddecreased $1.6$0.6 million, or 99%,29%, and increased $1.0 million, or 27%, for the three and six months ended June 30, 2026, respectively, compared to the same periods in 2025. The decrease in revenue for the three months ended MarchJune 31,30, 2026 comparedwas primarily due to timing of sample receipts and the sameearly periodclosure inof 2025.certain clinical trials. The increase in revenue for the six months ended June 30, 2026 was primarily a result of delivering against our expanding book of contracted business and securing new agreements.

Direct costs and expenses related to revenue increased $0.5$0.8 million, or 14%,20%, and $1.3 million, or 17%, for the three and six months ended MarchJune 31,30, 20262026, respectively, compared to the same periodperiods in 2025, primarily driven by thean increase in total testing volume. Additionally, during the threesix months ended MarchJune 31,30, 2026, the Company recognized a one-time recovery of previously paid sales and use taxes, which were recorded in Direct costs and expenses in prior periods.years. The recovery of $0.4 million was recorded as a reduction to Direct costs and expenses induring the currentthree period.months ended March 31, 2026. This item is non-recurring and is not expected to continue in future periods. Excluding this one-time recovery, Direct costs and expenses would have increased $0.9$1.7 million, or 25%,22%, compared to the samesix periodmonths inended June 30, 2025.

Research and development expenses increaseddecreased $0.4$0.1 million, or 14%,4%, and increased $0.3 million, or 5%, for the three and six months ended June 30, 2026, respectively, compared to the same periods in 2025. The decrease in costs for the three months ended MarchJune 31,30, 2026 compared to the same period in 2025. The increase in costs was primarily due to ana increasereduction in internal expenses associated with employee compensation and benefit costs resulting from ana decline in variable compensation. The increase in headcountcosts andfor variablethe compensationsix asmonths wellended asJune 30, 2026 was primarily due to an increase in external costs associated with clinicalcontracted trials.services.

The following table summarizes our external and internal costs for the three and six months ended MarchJune 31,30, 2026 and 2025 (in thousands, except percentages):

Sales, marketing, general and administrative expenses increased $3.8$1.9 million, or 19%,8%, and $5.7 million, or 13%, for the three and six months ended MarchJune 31,30, 20262026, respectively, compared to the same periodperiods in 2025. 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 sales and marketing educational and event expenses. These increases are due to the planned expansion of the sales team to support Lung Diagnostic sales growth, as well as to enhance Biodesix awareness and drive product adoption.

Interest expense increased $0.3$0.1 million, or 17%,4%, and $0.4 million, or 10%, for the three and six months ended MarchJune 31,30, 20262026, respectively, compared to the same periodperiods in 2025. The interest expense for the three and six months ended MarchJune 31,30, 2026 is primarily related to interest and amortization of debt issuance costs associated with the Perceptive Term Loan Facility of $2.0 million compared to $1.7 million for the three months ended March 31, 2025.Facility. The increase is due to the Company drawing the Tranche C loan of $10.0 million in May 2025.

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. In addition, on the Tranche C Loan borrowing date, the Tranche C Warrants, as amended, would become vested and exercisable at an exercise price equal to $15.86, the Company's closing stock price on February 28, 2025. During the three months and six months ended MarchJune 31,30, 2025, the Company recorded a $0.4gain of $0.1 million and a loss of $0.3 million as a change in fair value of warrant liability through the condensed statements of operations due to changes in unobservable inputs. This was a result of changes in the probability of our ability to draw on the Tranche C Loan. The Tranche C Warrants were subsequently reclassified to equity during the three months ended June 30, 2025 in connection with the draw of the Tranche C Loan.

During the three and six months ended MarchJune 31,30, 2026, the Company recorded no change in fair value of warrant liability through the condensed statements of operations.

During the three and six months ended MarchJune 31,30, 2026, the Company recorded other income, net of $0.4$0.1 million and $0.5 million, respectively, primarily related to interest and other income. During the three and six months ended MarchJune 31,30, 2025, the Company recorded other income, net of $0.1 million and $0.2 million, respectively, primarily related to interest income.

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). The shares of common stock offered pursuant to the 2024 ATM Program will be offered and sold by the Company pursuant to its registration statement on Form S-3 which became effective with the SEC on November 12, 2024. Sales of common stock under the 2024 ATM Program, if any, will be made at market prices by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on the NASDAQ Global Market, or any other existing trading market for our common stock. During the three and six months ended MarchJune 31,30, 2026, the Company raised approximately $17.2$6.7 million and $23.9 million, respectively ($16.7$6.5 million and $23.1 million, respectively, after deducting underwriting discounts anddiscounts, commissions and offering expenses payable), in gross proceeds from the sale of 1,771,103440,511 and 2,211,614 common shares at a weighted average price per share of $9.72.$15.14 and $10.80, respectively. The Company had remaining available capacity for share issuances of up to $25.5$18.8 million under the 2024 ATM Program.Program as of June 30, 2026.

Our cash flows resulted in a net increase in cash and cash equivalents and restricted cash of $6.6$11.0 million during the threesix months ended MarchJune 31,30, 2026 as compared to a net decrease in cash of $8.6$5.5 million for the threesix months ended MarchJune 31,30, 2025. For the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities totaled $10.2$11.7 million, ana increasedecrease of approximately $1.6$3.4 million compared to the same period in 2025 primarily due to a year-over-year decrease in net loss from operations of $7.5 million, partially offset by unfavorable changes in net working capital of $4.5$3.7 million resulting from the timing of cash receipts from customers and payments to vendors, partially offset by a year-over-year decrease in net loss from operations of $3.3 million.vendors.

Net cash used in investing activities during the threesix months ended MarchJune 31,30, 2026 totaled $0.1$0.4 million, ana insignificant$0.2 million increase compared to the same period in 2025. The increase in net cash used in investing activities was primarily due to increases in purchases of property and equipment and capital expenditures.

Net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2026 totaled $16.9$23.1 million, an increase of $16.8$13.3 million compared to the same period in 2025. The net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 primarily resulted from $17.2$23.9 million in gross proceeds from the issuance of common stock under our 2024 ATM Program and $0.4 million in net proceeds from our ESPP, partially offset by payments of $0.5$0.8 million in equity financing costs and $0.2$0.3 million associated with our finance lease obligations. The net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2025 primarily resulted from $10.0 million in net proceeds from the issuance of Tranche C under the Perceptive Term Loan Facility and $0.3 million in net proceeds from our ESPP, partially offset by payments of $0.2$0.4 million associated with our finance lease obligations.

The following table summarizes our non-cancelable contractual obligations and commitments as of MarchJune 31,30, 2026 (in thousands):

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 on MarchJune 31,30, 2026.

As of MarchJune 31,30, 2026, we have not entered into any off-balance sheet arrangements.

In accordance with accounting principles generally accepted in the United States, we are required to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Certain of these estimates significantly influence the portrayal of our financial condition and results of operations and require us to make difficult, subjective or complex judgments. Our critical accounting policies are described in greater detail below and in Note 2 to our condensed financial statements in Part 1I of this Quarterly Report on Form 10-Q as well as Part II, Item 8 of our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed on February 26, 2026.