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Biodesix to Present Data at IASLC 2022 World Conference

Biodesix to Present Data at IASLC 2022 World Conference Demonstrating that the VeriStrat® Test is Predictive of Progression Free Survival and Overall Survival in Patients with Low or Negative PD-L1 Treated with Immune Checkpoint Inhibitors

New data emphasizes the utility of the VeriStrat® Proteomic Test to identify patients likely to benefit from Immune Checkpoint Inhibitors

BOULDER, Colo.—(BUSINESS WIRE)—Jul. 20, 2022— Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today that Young Kwang Chae, MD, MPH, MBA, Associate Professor of Medicine (Hematology and Oncology) Feinberg School of Medicine, Northwestern University will present the results of a retrospective analysis at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC2022) on August 8, 2022 in Vienna, Austria.

The analysis from Northwestern University included patients with advanced-stage non-small cell lung cancer (NSCLC) who received Immune Checkpoint Inhibitors (ICIs) as monotherapy or in combination with chemotherapy with PD-L1 <50%. Patients underwent Biodesix’s blood-based VeriStrat proteomic testing from 2016 to 2021. This data demonstrated that the VeriStrat test result was predictive of Progression Free Survival (PFS) and Overall Survival (OS) in patients with NSCLC with low or negative PD-L1 treated with ICIs. Patients whose VeriStrat status results were VeriStrat Good (VS-G) had significantly greater PFS and OS as compared to the patients whose status was VeriStrat Poor (VS-P).

The VeriStrat test is a blood-based test utilizing a proteomic signature identified using MALDI-ToF mass spectrometry coupled with machine learning. Results from this test have been shown to have predictive and prognostic utility in different stages, histologies, and treatment types for patients with NSCLC. More recently, the VeriStrat test has also shown to be predictive of outcomes in patients receiving ICI treatment. Data in this study further enhances the existing data by showing the role of this blood-based test among lung cancer patients with low PD-L1 expression.

“The overall efficacy of ICIs in patients with low PD-L1 expression needs further investigation. Immune-checkpoint inhibitors targeting PD-1 or PD-L1 have already substantially improved the outcomes of patients with many types of cancer, although only 20-40% of patients derive benefit from these new therapies. A lower percentage of patients with low PD-L1 expression respond to checkpoint inhibitors, however those who do respond derive significant benefit,” said Young Kwang Chae, MD, MPH, MBA. “We need additional diagnostic tests, beyond PD-L1 testing alone, to better identify those likely to respond to checkpoint inhibition ahead of treatment initiation. This data shows potential for the VeriStrat test to play a role in this decision.”

Details for the e-poster presentations are as follows:

Title: The Role of Serum Proteomic Signature in Predicting Survival in PD-L1 Low Non-small Cell Lung Cancer Receiving Immune Checkpoint Inhibitor.

Authors: Leeseul Kim, Sung Mi Yoon, Joo Hee Park, Young Kwang Chae  Northwestern Feinberg School of Medicine, Chicago, IL

Abstract Number: P.2.12-04

Session Category: Tumor Biology and Biomarkers - Immune Biology & Immunotherapy

Session Date and Time: August 8, 2022, 5:15-7:15 pm CEST

Poster will be archived on the Biodesix website at www.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 is the first company to offer eight non-invasive 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 incidental 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® ddPCR test, the GeneStrat NGS test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting 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. Biodesix launched the SARS-CoV-2 ddPCR test, the Platelia SARS-CoV-2 Total Ab, and the cPass SARS-CoV-2 Neutralization Antibody test (cPass Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19. 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, it is 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.

Bobbi Coffin
(303) 892-3203

Chris Brinzey
(339) 970-2843

Source: Biodesix, Inc.