JANUARY 2021 Corporate Presentation Exhibit 99.2
This presentation and the accompanying oral presentation have been prepared by Biodesix, Inc. ("Biodesix", “we” or the "Company") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or Biodesix or any officer, director, employee, agent or advisor of Biodesix. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. Information provided in this presentation and the accompanying oral presentation speak only as of the date hereof.
Certain information contained in this presentation relates to, or is based on, studies, publications, surveys and other data obtained from third-party sources and Biodesix's own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source.
This presentation contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “should,” “will” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, factors, and assumptions, including among other things, the dependence of the commercial success of our current and future diagnostic tests and services on attaining significant market acceptance, difficulties we may experience in managing our growth, our failure to retain sales and marketing personnel and marketing capabilities or to develop broad awareness of our diagnostic tests, our failure to maintain our current relationships, or enter into new relationships, with biopharmaceutical companies, the demand for, and increased adoption of, our diagnostic tests, including our COVID-19 tests, being lower than we anticipate, our dependence on third-party suppliers, competition in our industry and specifically in the diagnostic tests space, our failure to offer high-quality support for our diagnostic tests and services which may adversely affect our relationships with providers and negatively impact our reputation among patients and providers. In addition, new risks may emerge from time to time and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation or to conform these statements to actual results or to changes in our expectations.
This presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Disclaimer
Robin Harper Cowie
Chief Financial Officer Scott Hutton
President & Chief Executive Officer Director of Payor & Government Relations
Manager of Business Development Planning & Analysis SVP & General Manager of the Vascular Intervention division Former Laboratory Manager, Researcher Presenting today Introductions Chief Operating Officer VP of Finance
VP of Reimbursement & Health Economics
Senior Director and Director of Reimbursement 20+ years of industry experience with expertise in Leadership | Mergers & Acquisitions | Sales & Marketing VP & General Manager of Neurosurgery
VP & Business Leader of Surgical Navigation
and Intra-Operative Imaging 15+ years of industry experience with expertise in Finance | Reimbursement | Operational Excellence
We strive to be a trusted partner that the world relies on for data-driven diagnostic solutions in lung disease by improving overall patient outcomes and lowering the overall healthcare cost by reducing the use of ineffective and unnecessary treatments and procedures.
140K+
sample &
data biobank We are a data-driven diagnostic solutions company Company Overview Experienced Leadership Team & Commercial Infrastructure Technology
Agnostic Approach to Precision Medicine 6
lung focused diagnostic tests 245K+
tests
performed 50+
biopharma
customers $29B+
total US market opportunity* Broad Reimbursement Coverage & Experience Unique
Lung Focused Diagnostic Testing Driving Biopharma Service Revenue & CDx Partnerships 27
clinical
studies 275+
publications & presentations Proprietary AI Platform &
Large Multimodal Biobank *Figure includes the US lung cancer testing opportunity of $27B plus the $2B biopharma biomarker and CDx opportunity studies
We have 6 diagnostic tests for lung disease Our Portfolio RESPIRATORY VIRUSES LUNG NODULES LUNG CANCER Tumor genetic profile – actionable tumor mutations Patients' immune response to cancer Identify likely benign nodules Identify
likely malignant nodules Hospital Systems, Employers,
Universities, State of Colorado Pulmonologists, Hospital Systems Pulmonologists, Medical Oncologists ddPCR Test* Total Ab Test* MOLECULAR
viral RNA detection SEROLOGY
IgG, IgM, IgA
antibodies *Commercialized in partnership with Bio-Rad Laboratories
$27B+ annual U.S. lung cancer testing market opportunity Lung Cancer Continuum of Care #1 deadliest cancer with more deaths annually than the next three deadliest cancers combined (colorectal, pancreas, and breast)
Identifying clinical unmet needs in patient care Lung Cancer Continuum of Care LUNG NODULE
RISK ASSESSMENT
pulmonologist CONFIRM DIAGNOSIS
pulmonologist,
thoracic surgeon TREATMENT DECISIONS
medical oncologist
thoracic surgeon DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION
medical oncologist
thoracic surgeon MONITORING 62% of biopsies are on benign nodules 35% of surgeries are on benign nodules 17% of patients sent to CT surveillance have cancer How can we improve the risk assessment of suspicious lung nodules? 50% of patients have insufficient tissue for molecular testing How can we ensure the right patient gets the right treatment quickly? 9 -day testing turnaround time is too long to wait for treatment decisions How can we identify disease progression earlier? & 20-40%
of stage I NSCLC patients recur after curative-intent surgery
Understanding lung nodule management CT Surveillance Diagnosis solitary pulmonary nodule risk calculator
(≤65% risk) Very Low Risk
(<5%) Low to Moderate Risk
(5-65%) High Risk
(>65%) 79.6% 9.5% 10.9% Physician Judgement identifies likely malignant nodules with test results in one day identifies likely benign nodules with test results in one week
Full commercial launch March 2020 Full commercial launch October 2019 Medicare coverage with a unique CPT code & ADLT status ($3,520) Beginning efforts with payers 4 to 5-day turnaround time Two studies ongoing (ORACLE & ALTITUDE) for combined lung nodule risk assessment and combined 26 peer-reviewed publications & presentations combined. Identifies patients with lung nodules that are likely malignant 1-day turnaround time Autoantibodies on an ELISA platform from blood
P53 | CAGE | NY-ESO-1|GBU4-5 | MAGE A4 | SOX2 | HuD 98% specificity, 28% sensitivity & 78% PPV Identifies patients with lung nodules that are likely benign Proteins on an LC-MS platform from blood (BCD)
Proteins: LG3BP | C163A
Clinical Profile: Age | Smoking History | Cancer History
Radiologic Profile: Nodule Size | Location | Spiculation 97% sensitivity, 44% specificity & 98% NPV Blood-Based Nodule Risk Assessment
We are committed to advancing our clinical data package Diagnosis ALTITUDE Clinical Utility Study ORACLE Registry Study First-in-class biomarker study for the early detection of lung cancer
Multicenter, randomized controlled, prospective clinical utility study
Initiated December 2020
Principal Investigator is Dr. Gerard Silvestri
2,000 patient enrollment goal
Interim results expected 2022 Observational registry study
Designed to evaluate the clinical utility of the Nodify XL2 test
Initiated October 2018
Principal Investigator is Dr. Michael Pritchett
423 patients have been enrolled and are undergoing primary endpoint analysis
2-year follow-up anticipated in 2022 https://clinicaltrials.gov/ct2/show/NCT03766958 https://clinicaltrials.gov/ct2/show/NCT04171492
Treatment Guidance & Monitoring Patients need to be given the right treatment as fast as possible tissue blood or Tumor
Profile Immune
Profile 4M+
molecular testing opportunities to guide NSCLC treatment decisions
VeriStrat Good (2x median survival) vs. VeriStrat Poor Mutations detected by ddPCR from blood
DNA: EGFR | BRAF | KRAS
RNA: EML4-ALK | ROS-1 | RET Medicare and private payer coverage
Not restricted by stage of NSCLC or multiple tests per patient per cancer Medicare and private payer coverage with a unique CPT code & ADLT status ($2,871) 85+ publications & presentations 30+ publications & presentations Greater than 3,500+ patients enrolled in INSIGHT1 registry study 3-day turnaround time 3-day turnaround time Identifies blood-based, guideline recommended NSCLC tumor mutations 91% sensitivity & 100% specificity Blood-based test identifies a chronic inflammatory disease state associated with aggressive cancer Proprietary proteomic signature identified from blood (BCD) by MALDI-ToF Mass Spectrometry & AI Blood-Based Tumor & Immune Profiling 1 https://clinicaltrials.gov/ct2/show/NCT03289780
DIAGNOSIS TREATMENT MONITORING Blood Tumor & Immune Monitoring Blood Blood CONFIRM DIAGNOSIS
pulmonologist,
thoracic surgeon TREATMENT DECISIONS
medical oncologist DISEASE PROGRESSION
medical oncologist Blood 9 days Results Liquid Biopsy NGS Tissue-Based NGS Tissue 26 days Results Informing initial treatment decisions with quick, actionable results Treatment Guidance & Monitoring We complement NGS testing by giving the physician a quick look at actionable mutation results to inform initial treatment decisions regarding FDA-approved targeted therapies and immunotherapies. Blood 3 days Results 3 days Results Blood
Our response to the COVID-19 pandemic Cancer Can’t Wait helps prioritize patients for diagnostic intervention with suspicious lung nodules helps inform treatment options and timing following a new lung cancer diagnosis supporting the pandemic with COVID-19 testing They asked, we responded.
We are a trusted partner to our pulmonology customers through their fight on the front-line with COVID-19 patients, meanwhile continuing to drive informed diagnostic and treatment decisions for patients with lung cancer.
Bio-Rad SARS-CoV-2
ddPCR Test Bio-Rad Platelia SARS-CoV-2
Total Ab Test 100% concordance with CDC assay
in symptomatic individuals Molecular test detected by ddPCR
SARS-CoV-2 N gene (N1 & N2) | human Rpp30 gene
Self-collect mid-nasal swab 98% sensitivity & 99% specificity
>8 days post onset of symptoms Detects active infection
identifies who should quarantine & self-isolate Detects previous infection
identifies who may have previously been exposed or infected Both tests are issued an Emergency Use Authorization by the FDA 1 to 2-day turnaround time 1 to 2-day turnaround time Serology test detected by ELISA
Antibodies to SARS-CoV-2: IgG | IgM | IgA
Blood draw Full commercial launch April 2020 Full commercial launch June 2020
We are committed to answering critical clinical questions in lung cancer Diagnostics in Development Risk of Recurrence (ROR) Test Primary Immune Response (PIR) Test We discovered a host immune profiling signature that can help identify stage 1 NSCLC patients' pre-surgery who are at a higher risk of recurrence and may benefit from adjuvant chemotherapy. We discovered a host immune profiling signature that provides clinically meaningful information for selecting treatment naïve NSCLC patients for immunotherapy regimens independent of, and complementary to PD-L1 expression status. Prospective clinical validation study (BEACON-Lung1) recently announced with ALCMI. 1 https://clinicaltrials.gov/ct2/show/NCT04676386
Biopharma Services Driving near-term & long-term value creation and ongoing revenue 50+companies 140,000+ sample & data biobank Significant experience to date working with biopharma customers Select publicly-disclosed
biopharma customers
Our 2020 accomplishments Reflection
PRODUCTS & SERVICES COLLABORATIONS DATA & STUDIES Streck
Merck KGaA & Pfizer
Bio-Rad
ALCMI
Colorado State University
Big Ten Conference
State of Colorado
Purdue University Nodify CDT test launch
Biodesix WorkSafe
ddPCR test launch
Ab test launch
Biodesix Blood Collection Device (BCD) On October 28, 2020, Biodesix began trading on the Nasdaq Global Market, under the symbol “BDSX”. 25+ peer-reviewed publications & posters
7 issued patents
Announced the BEACON-Lung observational study
Initiated the ALTITUDE clinical study
Our 2020 performance & long-term growth plan ($, in millions) Financial Overview *These are not projections; they are goals and are forward-looking, subject to significant business, economic, regulatory and competitive uncertainties and contingencies, many of which are beyond the control of Biodesix and its management, and are based upon assumptions with respect to future decisions, which are subject to change. Actual results will vary, and those variations may be material. Nothing in this presentation should be regarded as a representation by any person that these goals will be achieved and Biodesix undertakes no duty to update its goals. See page 2 of this presentation for factors that may impact our long term plan and our objectives for year over year growth set out above. Financial results estimates for the fourth quarter of 2020 are preliminary and subject to change as we complete our quarter closing procedures.
4Q19 IPO Funding Key Drivers
Expansion of commercial team
Sales
Marketing
Reimbursement
Customer Care
Expand our product portfolio available to physicians, and patients
Grow biopharma services by continuing to invest in
Business Development
R&D HISTORICAL BY YEAR LONG-TERM PLAN 2H2020 BY QUARTER Revenue Revenue $9.2 $25 to $27
Appendix
We derive our revenue from two sources Our Business Model DATA-DRIVEN
DIAGNOSTIC SOLUTIONS LUNG FOCUSED
DIAGNOSTIC TESTING BIOPHARMA SERVICES
DIAGNOSTIC DISCOVERY, DEVELOPMENT & TESTING Technology agnostic approach to solving clinical diagnostic challenges leveraging our proprietary artificial intelligence platform
Unique in our approach to precision medicine Our Platform 140,000+
Uncovering the depth and breadth of disease biology from blood Our Platform DIAGNOSTIC CORTEX® ARTIFICIAL INTELLIGENCE PLATFORM Biomarkers
Genomics (DNA, RNA)
Radiomics
Our Technologies
Droplet Digital PCR
Next Generation Sequencing Biomarkers
Proteomics
Post-Translational Modifications
Our Technologies
DeepMALDI Mass Spectrometry
Liquid Chromatography MS (LC-MS)
PASEF-timsToF Mass Spectrometry
ELISA
Understanding standard of care Lung Cancer Continuum of Care LUNG NODULE
RISK ASSESSMENT
pulmonologist CONFIRM DIAGNOSIS
pulmonologist,
thoracic surgeon TREATMENT DECISIONS
medical oncologist
thoracic surgeon DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION
medical oncologist
thoracic surgeon MONITORING physician judgement risk calculators imaging (CT & PET) biopsy surgery tissue blood or imaging
(CT & PET) symptoms chemo TKI ICI
Our portfolio of 4 blood-based diagnostic tests Lung Cancer Continuum of Care LUNG NODULE
RISK ASSESSMENT
pulmonologist CONFIRM DIAGNOSIS
pulmonologist,
thoracic surgeon TREATMENT DECISIONS
medical oncologist
thoracic surgeon DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION
medical oncologist
thoracic surgeon MONITORING How can we improve the risk assessment of suspicious lung nodules? How can we ensure the right patient gets the right treatment quickly? How can we identify disease progression earlier? Identify
likely benign nodules Identify
likely malignant nodules Tumor profile – actionable tumor mutations Patients’
immune response to cancer imaging (CT & PET) biopsy surgery Tumor profile – actionable tumor mutations Patients’
immune response to cancer
Case Study: Catching curable cancer with faster intervention Diagnosis PATIENT’S CLINICAL CHART PRE-TEST DECISION POST-NODIFY OUTCOME At the estimated pre-test risk of 39%, the patient was not comfortable with any invasive diagnostic procedures but was willing to undergo a blood draw for Nodify Lung testing. Nodify XL2 was cancelled.
Based on the test results, the patient proceeded with a biopsy, which was diagnosed as stage IA lung cancer.
Early detection identified the patient as a candidate for a potentially curative procedure. 10 mm spiculated lung nodule in the right upper lobe PET scan with a
3.3 standard uptake value (SUV) 64-year old female received a chest X-ray after a bad fall
Case Study: Changing lung cancer patient’s treatment plan Treatment Guidance & Monitoring PATIENT’S CLINICAL CHART Scans revealed multiple metastases (including brain). Staging confirmed stage IV adenocarcinoma. Former smoker (quit 1-year ago) 55-year old female presented to the clinic with a persistent cough and back pain Results
Immunotherapy is an option for the patient due to the GeneStrat mutation negative results
VeriStrat Poor identified the need to expedite time to treatment and be more aggressive with a treatment regimen
Outcome
The patient began treatment with a combination immunotherapy and chemotherapy regimen
Patient has been alive for over 18 months The physician advised the patient of her potential eligibility for single agent immunotherapy (based on a high PD-L1 status & less treatment side effects) but wanted to order molecular testing. Immunotherapy is more harmful in patients with either EGFR or ALK driver mutations. Biodesix Lung Reflex was ordered for a quick look for driver mutations & assessment of immune disease state. VERISTRAT POOR
[aggressive disease state] MUTATION NEGATIVE
[EGFR | EML4-ALK | ROS-1 | RET | BRAF | KRAS] TREATMENT PLANNING Pathology reported high PD-L1 (>50%).
Where our peer-products fit along the patient treatment pathway Lung Cancer Continuum of Care LUNG NODULE
RISK ASSESSMENT
pulmonologist CONFIRM DIAGNOSIS
pulmonologist,
thoracic surgeon TREATMENT DECISIONS
medical oncologist
thoracic surgeon DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION
medical oncologist
thoracic surgeon MONITORING imaging (CT & PET) biopsy surgery Percepta
(Veracyte) Nasal Brushing Classifier
(Veracyte)
-earliest anticipated launch 2H 2021
-claims ‘non-invasive’
-population limited to current or former smokers DetermaDx
(Oncocyte)
failed in validation Guardant360
(Guardant Health) FoundationOne Liquid
(Foundation Medicine) FoundationOne CDx
(Foundation Medicine) Imaging
(CT & PET) symptoms
Our testing strategies fit together in a simple portfolio Lung Cancer Continuum of Care CT surveillance or standard of care Low to Moderate (≤65%)
risk of malignancy High (>65%)
risk of malignancy LUNG NODULE IDENTIFIED LUNG CANCER DIAGNOSIS Nodule Risk Assessment Tumor & Immune Profiling Biopsy, surgery or standard of care Targeted therapy An aggressive disease state that may benefit from an alternate treatment plan
We employ a multifaceted strategy to drive Nodify Lung adoption Our Commercial Strategy & Key Successes CORPORATE
PARTNERSHIPS NATIONAL
SALES TEAM MARKETING & MEDICAL AFFAIRS LARGE U.S. HEALTHCARE SYSTEMS
HEALTH GROUPS
PATIENT ADVOCACY GROUPS Direct sales to lung-focused physicians E-MARKETING & ADVERTISING
EVENTS & TRADESHOWS
VIRTUAL ENGAGEMENTS
PEER-TO-PEER MEDICAL EDUCATION KOL DEVELOPMENT & PARTNERSHIPS | CLINICAL STUDIES | GUIDELINES INCLUSION| BROAD REIMBURSEMENT Driving inbound inquiries 1 2 3 System-wide integration
Our lung-focused sales force distributed across the U.S. Our Commercial Strategy 2020 year-end 2022 year-end* *Represents our objectives for 2022 based on current plans. Actual sales force distribution across geographies in the United States may differ as we reassess our plans.
Our team, capabilities and partnerships enable our speed and agility COVID-19 Testing Program MAR 13 Biodesix Remote Work Initiated for Non-Laboratory Personnel 2.5 weeks
from agreement to launch APR MAY 1 JUN JUL BIODESIX LAUNCH
Bio-Rad SARS-CoV-2
ddPCR Test FDA EUA
Bio-Rad SARS-CoV-2
ddPCR Test FDA EUA
Platelia SARS-CoV-2
Total Ab Test BIODESIX LAUNCH
Platelia SARS-CoV-2
Total Ab Test BIO-RAD AGREEMENT
ddPCR Supply 23 8 20 17 29 13 BIO-RAD AGREEMENT
Antibody Supply BIODESIX LAUNCH 8 3.5 weeks
from agreement to launch 14 BIO-RAD chooses Biodesix as COVID testing partner
$2B+ annual biopharma biomarker testing & CDx market opportunity Biopharma Services 1. LEK and PMC 2019. The evolution of biomarker use in clinical trials for cancer treatments. 2. Wong CH et al. Biostatistics, Volume 20, Issue 2, April 2019, Pages 273–286 The use of biomarker testing in clinical trials has increased from: Biomarker-driven drug development leads to a 570% increase in drug approval success rates 15% in 20001 55% in 20181
We provide end-to-end diagnostic solutions for biopharma customers Biopharma Services Discovery Commercialization Development Data-driven Diagnostic Solutions
Technology Agnostic Approach
Proprietary AI Platform
Tumor & Host/Immune Profiling
Multi-Omic & Single-Omic
Biomarker Discovery & Feasibility Two Highly-Certified Clinical Laboratories
Established Product Development Process
Proven Success at Rapid Diagnostic Development
Quality & Regulatory Excellence
Successfully Commercialized 6 Diagnostic Tests for Clinical Use
Experts in Reimbursement
National Field-Based Sales & Medical Affairs Team
In-House Billing & Customer Care TUMOR
PROFILING HOST & IMMUNE
PROFILING CAP-accredited
CLIA & COLA-certified
NYS CLEP certified
ISO 13485-certified
FDA Emergency Use Authorizations
Our suite of diagnostic testing solutions for biopharma customers GeneStrat 52 pan-Cancer cf Assay
Lung cfTNA Assay (12 genes)
Lung cfDNA Assay (11 genes)
Breast cfDNA Assay v2 (12 genes)
Breast cfDNA Assay (10 genes)
Colon cfDNA Assay (14 genes)
Myeloid Assay (40 DNA genes + 29 fusions)
Tumor Mutation Burden (TMB)
Comprehensive Assay Plus (500+ genes, TMB, MSI)
Whole Exome Sequencing
Methylome Sequencing
Whole Transcriptome Sequencing GeneStrat® Test*
(EGFR L858R, del19, UCV multiplex, T790M | ALK | ROS1 | RET | KRAS | BRAF)
SARS-CoV-2 ddPCR Test*
EGFR del19 multiplex*
EGFR C797S*
PD-L1 Expression
Microsatellite Instability
Custom Assays Nodify XL2™ Test
Lung Protein Panel (388 proteins)
MRM Assays
Unbiased DIA LC-MS
Direct Neoantigen Characterization
Custom Assays VeriStrat® Test
ImmunoStrat® Suite of Protein Signatures
Lung Cancer Risk of Recurrence Signature
Biological Pathway Protein Score (PSEA)
Antibody MALDI
Custom Protein Signature Discovery NGS ddPCR™ MALDI LC-MS *NYS-CLEP approved Bolded = commercial clinical diagnostic tests Nodify CDT™ Test
Platelia SARS-CoV-2 Total Ab Test ELISA Biopharma Services HOST & IMMUNE
PROFILING TUMOR
PROFILING TCR Beta (long & short read) Assay
Immune Expression Assay
Whole Transcriptome Sequencing
NGS
Title: ORACLE - An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test.
Status: The first patient enrolled on October 16, 2018. As of May 1, 2020, 423 patients have been enrolled and are undergoing primary endpoint analysis, with 2-year follow-up estimated to be completed by the first half of 2022.
Study Rationale: Designed to develop real-world clinical utility data for Nodify XL2.
Primary Objective: To show a reduction in invasive procedures on patients with benign nodules compared to a historical control group obtained from chart review. ORACLE Registry Study (NCT03766958) Diagnosis
Title: ALTITUDE - Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules.
Status: Received central investigational review board (IRB) approval in December 2019 and have an enrollment goal of 2,000 patients. First patient first visit was in December 2020.
Study Rationale: Designed to evaluate the performance of Nodify Lung (Nodify XL2 and Nodify CDT) in a randomized controlled study (RCT).
Objectives & Design: To evaluate how the addition of the Nodify Lung test result impacts the clinical decision making for patients with new, incidentally identified solid lung nodules assessed as low to moderate risk of lung cancer. The trial has an adaptive study design with a blinded standard of care arm and 2:1 randomization for open-label results for Nodify XL2.
Phase 1 of the study with only Nodify XL2 is expected to enroll 500 patients.
Phase 2 of the adaptive study design will include an open-label arm for Nodify CDT, which is aligned with our commercial testing algorithm.
ALTITUDE Clinical Utility Study (NCT04171492) Diagnosis
Title: An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer (INSIGHT)
Status: The first patient enrolled was on May 11, 2016. To date, we have over 3,500 patients enrolled with a target 5,000 enrollment goal. Final analysis with 3-year follow-up is estimated to be completed by 2024. Results of an interim analysis were presented at ASCO 2020.
Study Rationale: Designed to evaluate the real-world clinical utility and performance of the Biodesix Lung Reflex (GeneStrat and VeriStrat) testing strategy.
Objectives: To guide the adoption of VeriStrat and inform medical decision making, including treatment choice, and enable the validation of additional mass spectrometry-based proteomic tests. To describe the impact of the VeriStrat test results on treatment decisions, including but not limited to the percentage change in treatment decision, differences in chosen treatments between patients classified as VeriStrat Good and those classified as VeriStrat Poor, and the percentage of patients receiving systemic therapy or supportive therapies only.
INSIGHT Observational Study (NCT03289780) Treatment Guidance & Monitoring
Beacon-Lung Clinical Study (NCT04676386) Treatment Guidance & Monitoring Primary Immune Response Test Title: A Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With An Immune Checkpoint Inhibitor (ICI) With or Without Platinum-Based Chemotherapy
Status: This study will be carried out in collaboration with the Addario Lung Cancer Medical Institute (ALCMI) team. The IRB was submitted December 2020.
Study Design: An observational, multicenter, open-label study to assess biomarkers (serum, microbiome, radiomics and tissue) as predictive of early progression in 390 treatment-naive patients with advanced stage NSCLC and PD-L1 greater than or equal to 50% treated with two standard of care regimens, triplet therapy (platinum-based chemotherapy plus ICI regimen) and ICI monotherapy (single agent ICI).
Study Objective: To collect biospecimens and evaluate candidate biomarkers, with a focus on PIR, to detect early progression on ICI monotherapy versus triplet therapy.
Significant growth potential as we expand into lung disease Future Markets Acute respiratory distress syndrome (ARDS)
Biodesix WorkSafe Testing Partnerships & Testimonials COVID-19 Testing Biodesix to Provide COVID-19 Testing for Colorado State University Campus
August 12, 2020 Biodesix Partners with Boulder Community Health to Expand Access to COVID-19 Testing
May 20, 2020 Major League Lacrosse Partners with Biodesix
July 13, 2020 “Biodesix helped Carroll College organize and test more than 1,000 students on campus for COVID-19 over a one-week period. The Biodesix team was well organized, they responded to our questions promptly, and the turnaround time for testing results was as described. We are very satisfied with their work!” – Jennifer at Carroll College Big Ten Conference Partners with Biodesix, Inc. and Quidel Corporation
September 30, 2020 Purdue partners with Colorado company to offer rapid testing for students ahead of spring 2021 semester
January 6, 2021
We have two certified, high-complexity laboratories Appendix
CAP-accredited
CLIA-certified
NYS CLEP certified: Soluble Tumor Markers, Molecular & Cellular Tumor Markers and Virology
ISO 13485-certified
FDA Emergency Use Authorization COLA-accredited
NYS CLEP certified: Soluble Tumor Markers & Diagnostic Immunology
FDA Emergency Use Authorization We combined the Seattle, WA and De Soto, KS laboratories
Pre-analytic specimen collection solutions Laboratory & Business Operations We have enabled ambient shipping (‘no cold chain’) with specimen preservation for our diagnostic tests
Our patented Biodesix Blood Collection Device (BCD) Laboratory & Business Operations Whole Blood Transport & Plasma Separation Device
Combines multiple sample processing steps, including specimen collection and reproducible sample separation with ambient shipping.
Specimen detection has been demonstrated with analytic measures of proteins and gene targets using highly sensitive mass spectrometry, PCR and NGS methods.
We are exploring options to monetize the patented device in genomics and proteomics applications.
US Patent No. 10,422,729
Intellectual property portfolio Appendix 84 issued patents
49 in the US and 35 foreign;
16 U.S. and 23 foreign applications still in various stages of prosecution
33 registered trademark numbers
across 12 countries
Patent Subject Matter:
VeriStrat and Nodify tests and their uses in non-small cell lung and other diseases (e.g. breast cancer, prostate cancer, liver cancer, graft v. host disease)
DeepMALDI mass spectrometry methods
Classifier development using the Diagnostic Cortex
Pipeline tests using proteomic testing in immunotherapies
Biodesix Blood Collection Device
Proteomic drug-associated tests developed for our 3rd party partners Exemplary Issued Trademarks:
Biodesix
Biodesix Lung Reflex
DeepMALDI
Diagnostic Cortex
GeneStrat
ImmunoStrat
Nodify
Nodify XL2
VeriStrat
Filed not yet issued:
Nodify CDT
Nodify Lung
Multiple levers for growth Our Strategy Drive Increased Awareness, Adoption, and Reimbursement of Our Diagnostic Tests Deepen Relationships with Current and New Biopharma Customers Further Demonstrate Clinical Utility and Economic Benefits Introduce New Diagnostic Tests in Lung Disease Enhance Proprietary AI Platform and Expand Technology Portfolio Continue to Expand and Leverage Biobank
Extensive knowledge in diagnostics & reimbursement Our Leadership Team Scott Hutton
CEO Robin Harper Cowie
CFO Kieran O’Kane
CCO Gary Pestano
CDO (PhD) Robert Georgantas
SVP Research (PhD) Paul Beresford
CBO (PhD) Bobbi Coffin
CGO James Jett
CMO (MD) Steven Springmeyer
CMO (MD) Linda Traylor
VP CDMA (PhD)
A Board of Directors with a vast amount of industry expertise Appendix Birchview Capital Crabtree Partners LLC
