UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
Beginning on July 14, 2022, members of the management team of Biocept, Inc. (the “Company”) may be providing presentation materials (the “Presentation”) to certain interested parties. A copy of the Presentation is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information contained in this Current Report on Form 8-K and in the accompanying Exhibit 99.1 are being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by the Company, under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is being disclosed pursuant to Regulation FD.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Presentation materials of Biocept, Inc. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BIOCEPT, INC. | ||||||
| Dated: July 14, 2022 | By: | /s/ Samuel D. Riccitelli | ||||
| Name: | Samuel D. Riccitelli | |||||
| Title: | Interim President and Chief Executive Officer | |||||
Exhibit 99.1 TM Corporate Overview July 2022 Nasdaq: BIOC www.biocept.com 1 | © 2022 Biocept, Inc.
TM Forward-Looking Statements This presentation contains, and any accompanying oral presentation would no doubt contain, forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, regarding Biocept, Inc. and our business. Forward-looking statements include all statements that are not historical facts and generally can be identified by terms such as anticipates, believes, could, estimates, expects, intends, may, plans, potential, predicts, projects, should, will, would, or the negative of those terms and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For details about these risks, please see our SEC filings. All forward-looking statements contained in this presentation speak only as of the date hereof, and except as required by law, we assume no obligation to update these forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. 2 | © 2022 Biocept, Inc.
TM Investment Highlights Ø Pioneering proprietary CNSide™ assay using cerebrospinal fluid (CSF) to test for cancer involvement in the central nervous system (CNS); initial U.S. market opportunity of Dedicated to improving $1.2B outcomes for patients with advanced cancer. Ø Expanding CNSide usage among neuro-oncologist KOLs; 23 of 64 NCI-Designated Cancer Centers using CNSide Ø Pursuing CNSide standard of care status to support broader adoption and higher reimbursement by generating clinical data through FORESEE and company-sponsored investigator studies Ø Targeting collaborations with biopharma partners using CNSide assay to support therapeutics clinical trials Ø Serving the community and supporting our cash position with COVID-19 RT-PCR testing 3 | © 2022 Biocept, Inc.
Neuro-Oncology Market Overview 4 | © 2022 Biocept, Inc.
TM Recent Trends in U.S. Deaths Due to Cancer Ø Cancer deaths in aggregate declined >25% from 2000 to 2019 due to improved screening, diagnosis and prevention, lower smoking rates, and improved treatments Ø Deaths due to cancer of the brain and other nervous system (ONS) have unfortunately remained stable Ø Metastasis accounts for 90% of all solid tumor 1 cancer mortality 1. Taftaf, R. et al. Nature Communications 12, 4867 (2021). Source: 5 | © 2022 Biocept, Inc. • American Cancer Society • NCI SEER Statistics
TM Leptomeningeal Metastases (LM) Ø Cancer cells in the subarachnoid space/CSF Ø Solid and Hematologic malignancies Ø Symptoms: Ø High intracranial pressure and/or spinal cord compression Ø Cranial nerve symptoms Ø Spinal cord and nerve root involvement causing extremity weakness, paresthesia and/or pain. 1-4 Frequency of LM by Solid Tumor Type Breast cancer 12-35% Lung cancer 10-26% Melanoma 5 - 25% The most common cancers that develop LM are breast Gastrointestinal 4 - 14% cancer, lung cancer, melanoma, and GI malignancies. Unknown Primary 1-7% However, any malignancy may seed the leptomeningeal space. 6 | © 2022 Biocept, Inc. 1. J Neurooncol. 1990;9(3):225. 3. Neurology. 2010;74(18):1449. 2. Neurol Clin. 2003;21(1):25. 4. Posner JB. Neurologic complications of cancer, F.A. Davis, Phil. 1995.
TM LM Overall Solid Tumor Incidence 3-8% of solid tumor patients will be diagnosed with LM during the course 1-3 of their illness On average, leptomeningeal metastasis is detected 3.5X 20% of cancer patients 4-8 demonstrated LM at autopsy more frequently at autopsy than it is diagnosed clinically 40% of patients positive at autopsy had negative CSF cytology prior 4,5 to death 1. Jayson GC. Cancer 1994; 74:3135-41. 3. Smith DB. Eur J Surg Oncol 1985; 11:36-6. 5. Ongerboer de Visser BW. Neurology 1983; 33:1565-72. 7. Shapiro WR. Cancer Treat Rep. 1977;61(4):733. 7 | © 2022 Biocept, Inc. 2. Lee JL. J Neurooncol 2004; 66:167-74 4. Weitzner MA. Cancer 1995; 76:1804-8. 6. Posner JB. Neurologic complications of cancer, F.A. Davis, Phil. 1995. 8. Posner JB. Adv Neurol. 1978;19:579.
TM LM Unmet Clinical Needs 5 6,7,8 MRI Imaging CSF Cytology 5-8 Ø Underdiagnosed Ø MRI: low positive predictive value Ø Cytology: low overall sensitivity 3 9 NSCLC 1,2,3,4,9 Breast Ø Undertreated Ø Average survival w/o therapy: 4-6 weeks Ø Average survival w/ therapy: 2-4 months Ø Average survival w/ targeted therapy: 11-19 months 1. Batool A. Leptomeningeal Carcinomatosis. 5. Int J Cancer. 2015 Jan 1;136(1):162-71. StatPearls; 2022 6. Arq Neuropsiquiatr. 2013 Sep;71(9B):677-80. 2. J Neurooncol. 2013 Sep;114(2):229-35. 7. Semin Oncol. 2009 Aug;36(4 Suppl 2):S35-45. 8 | © 2022 Biocept, Inc. 3. J Thorac Oncol. 2012 Feb;7(2):382-5. 8. Neurology. 1979 Oct;29(10):1369-75. 4. Ann Oncol. 2020 Oct;31(10):1397-1404. 9. Breast Cancer Res Treat. 2019 Jun;175(3):781-788.
TM 2022 Independent Market Research – U.S. For LM: For PBM: Diagnosis and Diagnosis and Therapy Selection Therapy Selection CNSide TAM Literature Market Total Segment: Total Segment: $160M $287M (# of patients/year) Sources Research Diagnosis TAM parenchymal brain metastases 112,000 101,800 For PBM: For LM: Therapy Response, Therapy Response, (rule out LM) Disease Monitoring Disease Monitoring Treatment/Monitoring TAM Total Segment: Total Segment: 59,400 54,000 parenchymal brain metastases $255M $457M Diagnosis TAM 41,100 56,700 LM Treatment/Monitoring TAM Aggregate TAM for Diagnosis, Profiling, 21,800 30,100 and Monitoring in LM and PBM: LM TOTAL 234,300 242,600 Total Market: $1.2B 9 | © 2022 Biocept, Inc.
CNSide Assay Technology, Attributes, and Data 10 | © 2022 Biocept, Inc.
TM First commercially available real time method to measure biomarker status of CNS Ø Intended to determine the presence, quantity, and characterization of malignant cells in CSF Ø Currently performed primarily for suspicion of or diagnosis for LM * CLIA-Validated Test for Metastatic Carcinomas ü Sensitivity: 92% ü Specificity: 100% * 1 (N=79 Clinical CSF Samples ) 11 | © 2022 Biocept, Inc. 1 . VAL-AID-0038-S Validation Summary for Solid Tumor Cell (TC) Platform Assays for CNSide.
TM CNSide Identifies Biomarkers & Drug Targets in CSF Ø Tumor cells circulating in blood (CTCs) can infiltrate the CSF (a cul-de-sac) forming the basis for CNS metastasis Ø ctDNA and ctRNA derived from tumors can be shed into blood or CSF as cells die, but they do not confirm metastasis Ø Biocept analyzes tumor cells and cell-free DNA in CSF for diagnosis, biomarker status, and monitoring Central Nervous System(CNS) CSF Flow Cerebrospinal Fluid (CSF) 12 | © 2022 Biocept, Inc. Credit: H. McDonald/Science Translational Medicine.
TM CNSide Addresses Several Unmet Clinical Needs Is there TARGET Is there TUMOR Detection of LM can be improved using cell capture technology Therapeutic target selection can be informed by multiplexing cellular and molecular assays on single samples Is there TREND Quantifying results for longitudinal observations allows for disease monitoring 13 | © 2022 Biocept, Inc.
TM Biocept CNSide Proprietary Technology and Workflow* Patented Microfluidic Patented Antibody Cocktail Immunocytochemistry Tumor Cell Isolation Channel and FISH Tumor Cell Detection CTC Workflow MET FISH EGFR, KRAS, BRAF qPCR Actionable NGS Cell-free Sensitivity Enhancing Switch Mutation lung and breast DNA isolation Blocker™ Technology Detection cfDNA panels in CSF Detection Workflow 14 | © 2022 Biocept, Inc. * The Patented CEE-Sure™ sample collection tube can be used for either workflow
TM Biocept IP Portfolio – 42 Patents Issued Worldwide Family 1 MicroChannel for CTC Capture Expire Issued in US (3), China (3), EU PTO, Hong Kong (3), Japan, S. Korea, Canada ► Recovery of Rare Cells using Microchannel 2025-2027 ► Device for Cell Separation & Analysis Family 2 Sub 1) Issued in US (3), Australia (2), Canada, China, EU PTO (2), Hong Kong, Japan (4) CTC Capture With Antibody Cocktail Expire ► Subfamily 1 – Devices & Methods of Cell Capture Analysis 2030-2031 Sub 2) Issued in US, Canada, China, EU PTO, Hong Kong, Japan ► Subfamily 2 – Method and Reagents for Signal Amplification Family 3 Expire Collection Tube 1) Issued in US ► Use of DU for Anti-Clumping of Biological Sample 2031 Family 4 – In licensed from Aegea 1) Issued in US, Australia, EU PTO, Brazil, China, Hong Kong, Japan , S. Korea Switch-Blockers for use in real time PCR on CSF samples Expire ► Methods for Detecting Nucleic Acid Sequence Variants 2032 15 | © 2022 Biocept, Inc.
TM CNSide Publications, Posters, and Abstracts Eight Published CNSide Documents to Date 16 | © 2022 Biocept, Inc.
TM AAN April 2022: Longitudinal Use in Multiple Tumor Types & Longitudinal Genetic Heterogeneity of HER2 Status 17 | © 2022 Biocept, Inc.
TM 1 Case Study Demonstrating CNSide™ Utility 40-year-old Female • Breast Cancer Primary Tumor • Diagnosed with LM OFF TREATMENT ON TREATMENT Cells Cells Downtrend Uptrend 18 | © 2022 Biocept, Inc. 1 Sharma Et Al. Poster Presented at the Annual meeting for the American Association of Neurology (2022)
TM Promising Early Commercial Adoption of CNSide Unique Ordering Physicians 70 CNSide Order Trend 60 50 350 40 300 30 20 250 10 0 1Q'20 2Q'20 3Q'20 4Q'20 1Q'21 2Q'21 3Q'21 4Q'21 1Q'22 200 Unique Ordering Clients 150 50 45 40 100 35 30 25 50 20 15 0 10 5 1Q'20 2Q'20 3Q'20 4Q'20 1Q'21 2Q'21 3Q'21 4Q'21 1Q'22 0 1Q'20 2Q'20 3Q'20 4Q'20 1Q'21 2Q'21 3Q'21 4Q'21 1Q'22 19 | © 2022 Biocept, Inc. CNSide Commercial Orders Unique Clients Unique Physicians
FORESEE Clinical Trial A Prospective, Multi-Institution Study Led by Northwestern University 20 | © 2022 Biocept, Inc.
TM Biocept’s Clinical Trial - FORESEE Study (NCT#: NCT05414123) Objectives: Ø To determine the impact of CNSide in managing Leptomeningeal Metastasis in patients with Breast or Non-Small Cell Lung Cancer Ø Assess correlation of CSF Tumor cells with clinical response Ø Evaluate CNSide in helping to determine course of treatment Our Goal… Ø Study design: Clinical adoption to become standard of care Phase 1 Phase 2 ü Feasibility Studyü Validation Study ü Approximately ü Approximately 16-20 subjects 30-50 subjects 21 | © 2022 Biocept, Inc.
TM FORESEE Trial Schema Ø CNSide, imaging, CSF cytology and clinical results collected at baseline and 3 consecutive time points Ø Tumor cell detection by CNSide will be correlated with response to treatment Ø Impact of CNSide on treatment decision making will be assessed via physician questionnaire st rd nd 1 time 3 time 2 time 12 12 12 Baseline point point point Weeks Weeks Weeks Imaging Cytology Clinical Exam Data Collected @ Each Time Point 22 | © 2022 Biocept, Inc.
The Opportunity Building shareholder value with CNSide 23 | © 2022 Biocept, Inc.
TM CNSide Commercial Strategy Expand CNSide Usage Among Thought-Leaders 1 Ø Generate further engagement, experience, and advocacy for CNSide with this small core of experts and leaders Develop the Market 2 Target Market Ø Expand adoption through publication of FORESEE and company-sponsored investigator clinical utility results, KOL ► Neuro-oncologists and thought presentations, and exceptional customer experience leaders for early adoption (<1,000) Ø Expand to additional neurological indications ► Medical Oncologists (>12,000) Gain high-value reimbursement of >$4,000 per assay 3 Commercial Focus on Product Ø Near-term expansion of high-value biomarker coverage Development, Expanded Clinical Ø Transition to global coding and payment at proprietary pricing as clinical utility evidence develops Use, and Price Enhancement Inclusion in NCCN Guidelines for LM 4 Ø Support repeat testing for therapy response monitoring Ø Expand adoption to medical oncologists 24 | © 2022 Biocept, Inc.
TM 2022 Quantitative Market Research Key Survey Findings from 150 Medical Oncologists A majority are highly likely to use CNSide for diagnosis and therapy choice and more than half are highly likely to use CNSide for monitoring LM and parenchymal brain metastases Diagnosis & Therapy Choice Disease Monitoring % Highly Likely to Use CNSide % Highly Likely to Use CNSide 70% 62% 55% Average of 3 Times Leptomeningeal Mets Parenchymal Mets 25 | © 2022 Biocept, Inc.
TM Biocept in the CSF Liquid Biopsy Market Leptomeningeal Metastasis 1 Establish CSF beachhead in area with critical unmet needs Ø Significantly advance patient care and management 1 Ø >200,000 with CNS involvement PBM & Gliomas 2 4 POTENTIAL Expand to other neuro-oncology indications Ø Parenchymal brain metastases 3 FUTURE Ø Primary brain tumors Brain Metastases Screening 3 2 EMERGING Enable earlier detection Ø Emerging evidence of which high-risk primary solid tumors 1 are associated with metastases TODAY Ø Establish clinical evidence of utility Other neurological diseases 4 2 CSF analysis as a window into other CNS disease processes Ø Especially where cellular process are involved 1. https://www.cancernetwork.com/view/management-brain-metastases Ø Potential for neurodegenerative disease https://www.cancer.gov/about-cancer/understanding/statistics 2. Busse et al, Brain Behav Immun Health; V.14;2021 Jul 26 | © 2022 Biocept, Inc.
TM CNSide Biopharma Services – The Market Opportunity for CNS Metastases Key Catalysts for Growth CNS Metastases Studies Initiated from 2003-2022* Ø Incidence of brain metastases is rising as result of increased survival and 300 improved prognosis (~30% of patients) à Data from autopsy cohorts 275 1 suggest incidence much higher 250 214 Ø Biopharma is investing heavily in CNS metastases therapeutic development 200 – 100 programs initiated in past 5 years 156 150 Ø LM-focused studies have more than tripled in the past 15 years 90 100 Ø Advancements in local and systemic therapies have improved median 48 2,3 survival following initial CNS metastasis treatment 50 21 12 10 4 Ø Cancer Moonshot Initiative & ASCO recommendations : FDA is working 0 with sponsors to improve eligibility criteria of CNS metastases 2003-2007 2008-2012 2013-2017 2018-2022 Ø Urges metastatic patient inclusion in early-phase studies Years Initiated Ø Recommends inclusion of LM in early-phase trials of drugs with LM Studies PBM Studies anticipated CNS activity Ø Most CNS metastasis studies are in early phases à gives Biocept the opportunity to incorporate CNSide in protocol * Information obtained from http://www.clinicaltrials.gov Ø Parenchymal CNS metastases comprise the largest segment – Biocept IST trials will establish performance of CNSide in these populations and document new intended uses 27 | © 2022 Biocept, Inc. 1. Nat Rev Clin Oncol. 2020 May; 17(5):279-299 3. N Engl J Med 2018 Aug; 379: 722-730 2. J Clin Oncol. 2020 Aug; 38(32): 3773-3784. 4. J Clin Oncol. 2017 Nov 20;35(33): 3760-3773 Number of Trials
TM Biopharma Neuro-Oncology Services Pipeline Opportunity Stage Description 51 World Leading Cancer Inst. New Prospect!! • >4 pharma funded IST for ADCs Total Opportunities Breast Research Group (antibody-drug conjugates) in BrCa Top Tier Biopharma New Prospect!! • Several trans. research projects for 26 their LM pipeline Leads Top Tier Biopharma New Prospect!! • ADCs in LM 21 Major Cancer Research SOW submitted • Biopharam Funded IIS Prospects Network • ~$1M contract, CSF + blood BC-IPBM Study 3 Emerging Biopharma SOW Submitted • Phase 1.b 50 patients Proposal or SOW cMet Glioma Study • CSF: Custom Biomarker Capture + Stage NGS Emerging Biopharma Proposal Stage 1 NTRK LC-IPBM Study • Phase 1.b – 50 patients Contracting Stage / Closed Plus Therapeutics Contract Closed • Phase 1 & 2 – 182 patients st 186RNL LM Study 1 Patient Enrolled • CSF TC Enum @ 6 time pts • Est. $1.6+ million for both phases 28 | © 2022 Biocept, Inc.
TM Leveraging Expertise to Provide COVID-19 RT-PCR Testing >920,000+ COVID-19 samples received for SARS-CoV-2 testing since launch in June 2020 Ø Diverse base of business in clinics, skilled nursing and colleges leads to repeat testing per client Ø Fast turnaround times with vast majority of results reported in <48 hours Ø Performed with RT-PCR EUA molecular diagnostic platform Ø Testing performed in high-complexity, CLIA-certified and BSL-2 safety level lab by licensed molecular lab staff trained to perform COVID-19 testing Agreement with California Community Colleges Ø Providing access to testing as students return to in-person classes Ø Collaboration to provide a system for tracking and managing COVID-19 testing requirements and test results 29 | © 2022 Biocept, Inc.
TM COVID-19 Volume Drives Revenue Growth, Reducing Cash Burn Cumulative Samples Received 920,000+ Total Samples Received Medicare Reimbursement June 2020 – May 31, 2022 Ø $100 per test Lab Capacity to Meet Demand Ø COVID-19 volume drove increased capacity Ø Automation and investment in additional molecular technologies to meet demand Ø Ability to ramp to >10,000 tests per day Supports Investment in Core Neuro-Oncology Business 30 | © 2022 Biocept, Inc.
The Team 31 | © 2022 Biocept, Inc.
TM Leadership Team § Seasoned executive with 35+ years medical device & diagnostics experience Sam Riccitelli § Serial oncology diagnostics entrepreneur Chair, Interim President & CEO § Former COO at Genoptix, Inc. § Broad leadership experience in the US and Latin America with Fortune 100 and early-stage start-up companies Antonino Morales, CPA § Senior executive/consulting roles with Citibank, Bank of America, Arthur Andersen, McDonald’s, and Mazda Director, Interim CFO § University of Southern California; Licensed California CPA § 20+ years experience in oncology diagnostics and biopharma industries Philippe Marchand, PhD § Proven operations and technology track record as an executive § Extensive experience in rare cell isolation and analysis technologies COO § Board certified Pathologist Michael Dugan, MD § Univ of AZ, Yale, UCLA CMO and § Numerous publications, serves on CAP committees § Leadership positions at Exact Sciences, Clinical Genomics, Quest, Genzyme and others Medical Director § 20+ years of extensive legal expertise focusing on healthcare transactional, regulatory, and compliance matters Darrell Taylor, JD § 15+ years on the provider side at LabCorp of America and other clinical and research laboratories § Formerly with global law firm DLA Piper and in-house at Abbott Labs, AbbVie, and Sorrento Therapeutics SVP, CLO & CCO § The University of Texas Medical Branch and Notre Dame Law School § 25+ years commercial leadership experience in molecular diagnostics and med-tech companies Michael Terry § Former GE Healthcare executive, certified in Six Sigma SVP, Corporate Development § Recent experience in liquid biopsy field; EVP commercial operations at both Sequenom and Trovagene § 25+ years of industry experience including extensive oncology experience David Karlander § Record of success in building and managing major diagnostics brands SVP, Commercial Operations § Former executive sales and marketing positions at Exact Sciences and Novartis’ Genoptix Medical Lab 32 | © 2022 Biocept, Inc.
TM Board of Visionaries & Scientific Influencers Board of Directors Lead Clinical Advisors Ø Samuel D. Riccitelli Chair, Interim President & CEO Ø David Berz, MD, PhD Ø Marsha A. Chandler, PhD Beverly Hills Cancer Center Director, Chair of Nominating and Governance Committee Chief Medical Officer – Valkyrie Pharmaceuticals Beverly Hills, California Ø Bruce E. Gerhardt, CPA Director, Chair of Compensation CommitteeØ Santosh Kesari, MD, PhD Chair, Dept. of Translational Neuro-oncology and Ø Antonino Morales, CPA Neurotherapeutics, John Wayne Cancer Institute, Director, Interim CFO Santa Monica, California Ø Ivor Royston, MD Ø Priya Kumthekar, MD Director, Chair of Science and Technology Committee Associate Professor of Neurology (Neuro Oncology) Ø Linda Rubinstein and Medicine (Hematology and Oncology) Director Northwestern Medicine Ø M. Faye Wilson, CPA, MBA Feinberg School of Medicine Lead Independent Director, Chair of Audit Committee Chicago, IL 33 | © 2022 Biocept, Inc.
TM Corporate Priorities 1 2 3 4 Establish CNSide as Position Biocept as Facilitate metastatic Initiate FORESEE clinical standard of care for leader in emerging brain cancer therapy validity & utility study diagnosis, identifying category of neurological development by leading to guideline potential treatments tumor diagnostics st establishing revenue- inclusion – 1 patient and monitoring for CNS generating biopharma enrolled in 3Q’22 involvement company partnerships 5 6 7 8 Initiate company- Develop additional Establish MolDx Publish CNSide clinical sponsored investigator strategic commercial reimbursement study results in studies to support and technology respected, peer- commensurate with clinical validation and partnerships to st reviewed journals findings from published expanded use – 1 accelerate neurological clinical studies study initiated by diagnostic offerings 2022-year end 34 | © 2022 Biocept, Inc.
TM Investment Highlights Ø Commercializing CNSide assay to test for cancer involvement in CNS; initial U.S. market opportunity of Dedicated to improving $1.2B outcomes for patients with advanced cancer. Ø Expanding CNSide usage among neuro-oncologist KOLs Ø Pursuing CNSide standard of care status to support broader adoption and higher reimbursement Ø Targeting collaborations with biopharma partners using CNSide assay to support therapeutics clinical trials Ø Serving the community and supporting our cash position with COVID-19 RT-PCR testing 35 | © 2022 Biocept, Inc.