Solitary Pulmonary Nodule

Studies highlight the clinical utility and real-world impact of the Nodify CDT® and Nodify XL2® tests in managing both benign and malignant pulmonary nodules. BOULDER, Colo.--(BUSINESS WIRE)-- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung disease, today announced that new data will be presented at the CHEST Annual Meeting 2023 in Honolulu, Hawaiʻi. These presentations will provide new insight on the clinical utility and real-world impact of the Nodify CDT and Nodify XL2 tests in the comprehensive management of lung nodules. The first abstract, titled "Real-World Impact of a Blood-Based Integrated Classifier on the Management of Benign Solid, Part-Solid, and Ground Glass Pulmonary Nodules," will be presented by Jonathan Kurman, MD, Director of Interventional Pulmonology at the Medical College of Wisconsin, on Tuesday, October 10 at 12:00 pm HT (6:00 pm ET). The presentation will delve into subgroup analyses from the prospective, real-world ORACLE study (NCT03766958), evaluating the clinical utility of the Nodify XL2 test across the spectrum of nodule types. The recently published primary endpoint of the study highlighted a 74% reduction in invasive procedures on benign nodules with use of the test. The analysis will demonstrate that this reduction is consistent across solid, part-solid, and ground glass lung nodules. Dr. Kurman, remarked, "The data we're presenting at CHEST 2023 underscores the transformative potential of the Nodify XL2 test in managing all types of lung nodules. Clinical guidelines recommend different management strategies for solid versus non-solid nodules and this data indicates the test can be used broadly to avoid unnecessary invasive procedures." The second abstract, titled "Comparison of a High Specificity Blood-Based Biomarker with PET/CT for Identifying Malignant Pulmonary Nodules," will be presented by Kathryn Long, MD, Pulmonary and Critical Care Fellow at the Medical University of South Carolina, on Wednesday, October 11 at 12:00 pm HT (6:00 pm ET). The presentation will demonstrate the complementary nature of the Nodify CDT test and PET/CT imaging results. PET/CT is a common imaging technique that detects abnormal levels of cellular metabolism and is clinically valuable in detecting cancer that has spread throughout the body. However, published data shows that the performance of PET/CT imaging alone is compromised in assessing small lung nodules for cancer. The analysis will demonstrate that the Nodify CDT test alongside PET/CT improves the performance, identifying malignant nodules with a high level of accuracy. Additionally, independent studies by external investigators are expected at the event. "Novel Lung Cancer Biomarker Proteomic Testing on Lung Nodule Risk Stratification and Clinical Implications at a New York City Safety Net Hospital," is set to be presented in a rapid-fire format by Dr. Sonu Sahni, MD on Monday, October 9 at 12:00 pm HT (6:00 pm ET). Independent studies underscore the growing utility and adoption of Nodify Lung testing in the pulmonology community. On Tuesday, October 10 at 1:00 pm HT (7:00 pm ET), Michael Pritchett, DO, and Jonathan Kurman, MD, will discuss the "Reduction of Diagnostic Interventions on Benign Lung Nodules: Results from the Nodify XL2® Clinical Utility Study" at Learning Theater 4. This presentation will highlight the ORACLE study's findings, covering primary and exploratory endpoints as well as multiple subgroup analyses from the study that have been published to date. About Biodesix Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com. Note Regarding Forward-Looking Statements This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on Biodesix and its operations, its possible or assumed future results of operations, including descriptions of its revenues, profitability, outlook, and overall business strategy. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company's ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix’s most recent annual report on Form 10-K, filed March 14, 2022 or subsequent quarterly reports on Form 10-Q during 2022, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement. View source version on businesswire.com: View source version on businesswire.com: Contacts Media: Robbie Lunt robbie.lunt@biodesix.com 1-866-432-5930 Investors: Chris Brinzey chris.brinzey@westwicke.com (339) 970-2843 Source: Biodesix, Inc. View this news release online at:

Data demonstrates a 51% relative increase in the proportion of lung nodule biopsies diagnosing cancer BOULDER, Colo.--(BUSINESS WIRE)-- Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today that a new analysis from the post-market, prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test NCT03766958) will be presented at the 6th Annual Conference of the American Association for Bronchology and Interventional Pulmonology (AABIP). The data will be presented by principal investigator of the ORACLE study, Michael Pritchett, DO, MPH, on Thursday, Aug. 24, 2023 in a live poster presentation in Chicago, IL. The Nodify XL2 test is designed to identify likely benign lung nodules that can be monitored with computed tomography (CT) scans instead of costly invasive procedures. The primary endpoint of the ORACLE study demonstrated that patients with benign lung nodules managed with the 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. The analysis to be presented at AABIP investigated the effect of improved identification of benign lung nodules on the remaining patients who received a diagnostic biopsy. Prior to implementation of the Nodify XL2 test, 49% of patients receiving a biopsy had a lung cancer diagnosis compared to 74% when the test was used in clinical decision making, representing a 51% relative increase in the cancer diagnosis rate. “Finding a suspicious lung nodule can create fear and anxiety for patients, whether it is found through lung cancer screening or an incidental finding from imaging for general medical purposes,” said Dr. Pritchett. “It is very encouraging that the Nodify XL2 test is helping physicians avoid unnecessary invasive procedures on benign lung nodules and prioritize patients with a higher risk of lung cancer. These results offer peace of mind to both patients and providers as they navigate the diagnostic plan.” About Biodesix Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com. Note Regarding Forward-Looking Statements This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on Biodesix and its operations, its possible or assumed future results of operations, including descriptions of its revenues, profitability, outlook, and overall business strategy. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company's ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix’s most recent annual report on Form 10-K, filed March 14, 2022 or subsequent quarterly reports on Form 10-Q during 2022, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement. View source version on businesswire.com: Contacts Media: Robbie Lunt robbie.lunt@biodesix.com 1-866-432-5930 Investors: Chris Brinzey chris.brinzey@westwicke.com (339) 970-2843 Source: Biodesix, Inc. View this news release online at:

Second quarter 2023 Core Lung Diagnostic revenue of $11.4 million increased 58% over the comparable period in 2022 and 33% over the first quarter of 2023; Second quarter 2023 gross profit margin of 73% versus 64% for the second quarter 2022 and 65% for the first quarter 2023; Revenue continues to track to 2023 full year guidance of $52-55 million; Approximately $27.5 million in common shares sold under a private placement from the Company’s largest investors, Board of Directors members, and Executive Leadership team; Multiple publications and data presentations on the clinical utility and health economic benefits of Core Lung Diagnostics tests; Conference Call and Webcast Today at 4:30 p.m. ET BOULDER, Colo.--(BUSINESS WIRE)-- Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced its financial and operating results for the second quarter ended June 30, 2023 and provided a corporate update “I am very pleased to announce another record-setting quarter from our core lung diagnostics,” said Scott Hutton, President and Chief Executive Officer. “In addition to continued sales growth, we had a number of important publications this past quarter that highlighted the benefits to patient care of our lung diagnostic tests in a real-world, clinical setting. We are also happy to announce the successful completion of a private placement that included some of our largest shareholders and management. All board members, all Section 16 officers, and additional members of the Biodesix leadership team participated in the round raising $27.5 million in equity funding to further support our growth. We also maintained strong cost discipline, with sustainable and improving gross margins to 73% from 65%, and reducing our Operating Expense excluding direct costs and expenses by $2.7 million, all versus first quarter 2023. We continue to focus on projects and initiatives that drive near term-revenue growth, while reducing expenses and cash burn. Overall, the progress and positive trends in our core lung diagnostics tests in the first half of the year solidifies our confidence in reaffirming our 2023 revenue guidance and making progress on our path to profitability.” Business Highlights Biodesix continues to publish new data supporting the value and utility of their lung diagnostics portfolio. The Company was pleased to announce the following accomplishments: Published the achievement of the primary endpoint of the prospective ORACLE clinical utility study, demonstrating that use of the Nodify XL2 test resulted in a 74% decrease in unnecessary invasive procedures on patients with benign lung nodules compared to the control group; Researchers from Beth Israel Deaconess, Tulane University, and Einstein Medical Center published an independent, multi-center study demonstrating that use of the Nodify XL2 test resulted in a 73% reduction in the number of invasive procedures compared to the control arm; Presented new health economics data on the Nodify XL2®, Nodify CDT®, and VeriStrat® tests at the American Society of Clinical Oncology (ASCO) and the International Society for Pharmaceutical and Outcomes Research (ISPOR). These data indicate savings to the US healthcare system with use of the tests; Completed enrollment of 5,000 patients with non-small cell lung cancer (NSCLC) in the large multi-center observational registry study INSIGHT. The study was designed to further validate the utility of the VeriStrat test; Announced that CMS has designated the Nodify CDT Test as an Advanced Diagnostic Laboratory Test (ADLT) effective June 30, 2023. 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. Second Quarter 2023 Financial Results For the three-month period ended June 30, 2023, as compared to the same period of 2022 (where applicable): Total revenue of $11.9 million, an increase of 8% including COVID testing revenue in second quarter 2022, driven primarily by strong year-over-year growth in core lung diagnostics, and a 48% year-over-year increase excluding COVID testing revenues from the prior year comparison. Core lung diagnostic revenue of $11.4 million reflected a year-over-year increase of 58% driven primarily by the continued adoption of Nodify Lung® nodule management tests; BioPharma Services revenue of $0.4 million decreased 43% year-over-year. Timelines for existing and new agreements continue to be impacted by delayed enrollment in clinical trials; entered the third quarter of 2023 with continued strong dollars under contract; COVID-19 testing revenue decreased by 100% year-over-year, the Company no longer provides COVID-19 diagnostic testing services commercially; Second quarter 2023 gross profit of $8.6 million, or 73% gross margin as compared to 64% gross margin in the comparable prior year period primarily driven by growth in Lung Diagnostic Testing and optimization of testing workflows that resulted in improvements in costs per test, and the commercial discontinuation of our lower-margin COVID-19 diagnostic testing; Operating expenses (excluding direct costs and expenses) of $19.6 million, an increase of approximately $1.0 million, or 5% as compared to the second quarter 2022 (includes non-cash stock compensation expense of $1.1 million as compared to $1.4 million). This increase is primarily attributable to increased sales and marketing costs to support core lung diagnostic sales growth including increased travel-related costs and marketing programs to enhance product awareness as we actively participate in an increasing number of peer-to-peer physician educational events; Net loss of $13.4 million, a decrease of approximately $2.5 million, or 16%; Cash and cash equivalents of $17.4 million as of June 30, 2023, a decrease of $7.9 million from March 31, 2023. This represented an improvement of approximately 56% in cash utilization versus the cash utilized in the first quarter 2023; Scheduled milestone payment of $2.3 million paid in April 2023 to Integrated Diagnostics; Subsequent to quarter end, raised $27.5 million in gross equity proceeds from a private placement to be used for commercial expansion of sales, research and development, and for general corporate purposes. 2023 Financial Outlook The Company reaffirms our 2023 financial outlook and expects to generate between $52 million and $55 million in total revenue in 2023. Conference call and webcast information Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. For a full list of Biodesix’s press releases and webinars, please visit biodesix.com. About Biodesix Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com. Note Regarding Forward-Looking Statements This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on Biodesix and its operations, its possible or assumed future results of operations, including descriptions of its revenues, profitability, outlook, and overall business strategy. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company's ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix’s most recent annual report on Form 10-K, filed March 6, 2023 or subsequent quarterly reports on Form 10-Q during 2023, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement. Biodesix, Inc. Condensed Balance Sheets (unaudited) (in thousands, except share data) June 30, 2023 December 31, 2022 Assets Current assets Cash and cash equivalents $ 17,409 $ 43,088 Accounts receivable, net of allowance for doubtful accounts of $150 and $118 4,119 5,065 Other current assets 3,717 5,181 Total current assets 25,245 53,334 Non‑current assets Property and equipment, net 18,996 5,848 Intangible assets, net 8,871 9,797 Operating lease right-of-use assets 2,492 2,973 Goodwill 15,031 15,031 Other long-term assets 6,988 5,923 Total non‑current assets 52,378 39,572 Total assets $ 77,623 $ 92,906 Liabilities and Stockholders' (Deficit) Equity Current liabilities Accounts payable $ 3,501 $ 1,685 Accrued liabilities 6,981 8,218 Deferred revenue 1,069 962 Current portion of operating lease liabilities 1,504 1,543 Current portion of contingent consideration 14,561 10,341 Current portion of notes payable 50 49 Other current liabilities 285 41 Total current liabilities 27,951 22,839 Non‑current liabilities Long‑term notes payable, net of current portion 24,658 25,004 Long-term operating lease liabilities 18,808 5,254 Contingent consideration 12,303 18,645 Other long-term liabilities 896 558 Total non‑current liabilities 56,665 49,461 Total liabilities 84,616 72,300 Commitments and contingencies Stockholders' equity Preferred stock, $0.001 par value, 5,000,000 authorized; 0 (2023 and 2022) issued and outstanding — — Common stock, $0.001 par value, 200,000,000 authorized; 78,610,663 (2023) and 77,614,358 (2022) shares issued and outstanding 79 78 Additional paid‑in capital 392,406 387,948 Accumulated deficit (399,478 ) (367,420 ) Total stockholders' (deficit) equity (6,993 ) 20,606 Total liabilities and stockholders' (deficit) equity $ 77,623 $ 92,906 Biodesix, Inc. Condensed Statements of Operations (unaudited) (in thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Revenues Lung diagnostic $ 11,449 $ 7,252 $ 20,081 $ 11,901 COVID-19 — 2,954 13 3,938 Diagnostic testing revenue 11,449 10,206 20,094 15,839 Biopharma services 423 744 834 1,659 Total revenues 11,872 10,950 20,928 17,498 Direct costs and expenses 3,238 3,980 6,407 7,215 Research and development 2,910 3,361 6,161 6,567 Sales, marketing, general and administrative 16,651 15,235 35,640 29,722 Impairment loss on intangible assets — — 20 81 Total operating expenses 22,799 22,576 48,228 43,585 Loss from operations (10,927 ) (11,626 ) (27,300 ) (26,087 ) Other (expense) income: Interest expense (2,430 ) (1,346 ) (4,821 ) (2,483 ) Loss on debt extinguishments, net — (2,952 ) — (2,952 ) Change in fair value of warrant liability — — 61 — Other income, net 1 100 2 112 Total other expense (2,429 ) (4,198 ) (4,758 ) (5,323 ) Net loss $ (13,356 ) $ (15,824 ) $ (32,058 ) $ (31,410 ) Net loss per share, basic and diluted $ (0.17 ) $ (0.40 ) $ (0.41 ) $ (0.89 ) Weighted-average shares outstanding, basic and diluted 78,506 39,239 78,138 35,177