BIOCEPT INC FORM FWP. (Free Writing Prospectus - Filing under Securities Act Rules 163/433) Filed 01/22/15

Transcription

1 BIOCEPT INC FORM FWP (Free Writing Prospectus - Filing under Securities Act Rules 163/433) Filed 01/22/15 Address 5810 NANCY RIDGE DR SAN DIEGO, CA, Telephone CIK Symbol BIOC SIC Code Services-Medical Laboratories Industry Medical Equipment, Supplies & Distribution Sector Healthcare Fiscal Year 12/31 Copyright 2018, EDGAR Online, a division of Donnelley Financial Solutions. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, a division of Donnelley Financial Solutions, Terms of Use.

2 Issuer Personalized Free Writing Medicine Prospectus from a Liquid Filed Pursuant Biopsy to Rule 433 Registration No Date: January 21, 2015

3 Forward Looking This (Biocept, may, Forward-looking performance All any forward new presentation plans, information, Inc.) potential, and achievements contains, Statements our statements future predicts, business. and events, involve expressed projects, any contained Forward-looking accompanying changed known should, implied and this circumstances will, unknown presentation statements oral by would, the presentation forward-looking risks, speak include otherwise. uncertainties negative only would all as 1 no statements. of and doubt the those other date that contain, terms hereof, For factors are and details not forward-looking and which similar historical about except may expressions. these facts as cause required statements, risks, and our generally please actual by law, within see results, can we our assume the be SEC performance identified meaning filings. no obligation of by or the terms achievements Private to such update Securities as anticipates, these to be forward-looking Litigation materially believes, Reform different could, statements Act from estimates, of 1995, any whether future expects, regarding results, as a intends, result us of

4 FWP This in We registration filed You Alternatively, Corp., our have may presentation with Statement common Prospectus filed access the statement SEC we a stock. registration these highlights or Department, for any has documents more underwriter not statement complete basic yet 810 become Seventh participating free information (including effective. by Avenue, visiting about a in about prospectus, Before the EDGAR 18th and offering Floor, you and the on which offering invest, the New will the offering. SEC currently arrange York, you to website which should NY to is send 10019, this in read at preliminary you communication the telephone: the preliminary form) , relates. with The prospectus the Because preliminary US in Securities and, the registration prospectus, when prospectus@aegiscap.com a summary, and available, Exchange statement dated it does the January Commission final not (including contain prospectus [21], 2 for 2015, the all of the risk and/or the offering factors available information any described to supplements on which the that SEC this therein) you thereto presentation Web should and site if consider other you relates. contact documents before The Aegis investing we Capital have

5 Issuer Exchange/Ticker Offering Over-Allotment Sales Use Automation Joint of Book-Runners and Biocept, Proceeds Summary Size marketing and Approx. Inc. 15% scale Assay NASDAQ Aegis for (100% up $15,000,000 development test Capital offerings Primary) Corp. Market and Common and validation / Feltl BIOC Stock and Company (100% Primary) 3

6 Biocept s Answering Do The 4 I Right qualify Liquid Therapy an for Unmet this Biopsy for drug? Medical the Solution Right Does Need my Patient treatment the need Right to Time be changed?

7 Business R&D Clinical Development CLIA San & Diego, D, Manufacturing facility test Overview CA kits Lab results manufactured Genomic sent test to physicians and samples analyzed 5

8 Investment OncoCEE : CEE-Selector : Commercialized Clear path Highlights stage market captures tests enhanced cancer penetration for circulating breast, diagnostics sensitivity Established gastric tumor company for and cells genomic non-small research (CTCs) with mutation ground-breaking collaborations cell lung analysis cancer and technology Test strategic pipeline platform partnerships focused utilizing on 6 solid a simple tumor biomarkers blood test in lung, breast, colorectal, prostate and melanoma Established, certified and scalable CLIA lab

9 Biocept David Chairman CEO Michael President Healthcare 25 William Diverse Senior Lyle SVP, 40 Veena Most Director More Raaj Life years issued Commercial Technologies and Trivedi Arnold, of recently Finance R&D than Hale Singh, Hybritech Executive finance Nall Kachioff life Sr. and US Amgen), Company and Chairman sciences Leadership Served Ph.D. BioPharma 16 and years MD CEO Medical CSO and Operations years more 15 CFO Board Commercial (acquired Team Most Founder/ and in operations as years Former Numerous industry healthcare the (current Director VP than Abbott SkinMedica cancer certified Ventures recently biotechnology of Gen-Probe, Company 140 by Co-founder faculty Marketing experience or Labs, management Leader Lilly), diagnostics publications, issued sales, former) biotheranostics General molecular with (acquired member, Cutera, Gensia Incyte marketing over and Oasis of Manager Oncomine public pending and Santarus experience pathologist, VP 36 diagnostics Coulter serves Genomics, UCSD (acquired by Biosciences, years genomics of Allergan) and company Business N. patents on Pharmaceutical, School (acquired Biomarker as commercial American CAP by a industry UCSD, Genta life Teva) worldwide finance Molecular Development of committees sciences by Medicine Discovery Cedars Sales operations Salix), Althea, and sector Biosystems, Sinai for and Conatus, Marketing Panel oncology Clarient leader Vivus member, trained 7 Micromet Aegea for biomarkers UCSD a GE Clarient a Biotechnologies Healthcare (acquired Cancer GE Center by

10 Multifaceted Sales Research Operational Physician Biopharma Collaboration Clinical Validation Enhanced Investment Optimize and and Marketing utility capacity technology Efficiency of Growth and Development test automation and hospital studies research in partnership of Investment Strategy pipeline infrastructure market services agreements for treatment 8 decisions

11 2014 Appointed patients Gained Secured ER Accomplishments breast and $10 large Veena Raaj expanded cancer; Million Trivedi PPO Singh ALK, Term network collaborations as Vice Loan ROS1 SVP Awarded President Commercial Facility and Senior with T790M/EGFR additional With MD Medical Anderson, Oxford issued Director in Finance NSCLC Operations Rosetta patents LLC and in Europe, Increased Recruited HER2 Insight in China Launched gastric menu a national and of cancer. S. testing: Clinical sales Korea 9 team Research to support Services commercialization in Circulating Tumor Implemented DNA reimbursement and managed care plan Gained coverage for approx. 19M

12 Target 925,030 Newly 8,009,272 Living provided 10 Incidence Market with Diagnosed by data Cancer National for Cancers 2014 and Institute: prevalence data for 2010 of breast, lung, colon, prostate, melanoma, gastric and deaths data

13 Liquid liquid Cowen Profiling Newly In Monitoring Patients DeSantis, thousands Diagnosed Biopsy Living biopsies et Company al Opportunity (2014). with Cancers have Liquid Cancer a multi-billion Biopsy Treatment Industry dollar & Survivorship market Report, potential November, Statistics that 2014 could 11 eventually exceed $10B

14 Limitations Cancer Liquid 12 Molecular Primary Therapy May Impractical Greater Surgery not Biopsy is a demand is tumor causes be heterogeneous of costly properties feasible for Tissue Addresses biopsy periodic changes due Biopsy based to differ may molecular Limitations monitoring in disease tumor not within patient reflect cells profiling a for in tumor condition current Standard Biopsy progression disease or of invasive tumor Care / recurrence condition accessibility Biopsy tissue is limited

15 Reducing Average. 1Lokhandwala October 213 potentially 30-November cost Healthcare when of saving T, biopsy: blood Dann adverse Costs our draw: 1, R, $14, ; healthcare Johnson events between Chicago, such M, system $6 et as and Illinois. al. collapsed billions Costs $167 Presentation 2 of lung, the Diagnostic bleeding Number: or Workup pneumonia for Lung occurred Cancer A was 4X Medicare higher1 Claims Analysis. Presented at: 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology;

16 New Liquid attributable 66% *CTC 14 of Molecular industry biopsy researchers to (CTCs heterogeneity overview Paradigm say and analysis ctdna) Hanson Detect of CTCs and metastasis, surrogate Wade will be 2013 for recurrence the tumor standard tissue of biomarker biopsy care by Repeatable 2017* conversion for Qualify monitoring more patients response for targeted to treatment therapies Provides tumor biomarker status when tissue is not available Reduce false negatives

17 Platform ctdna B-Raf ZELBORAF & CTC HER2 HERCEPTIN 15 IRESSA Analysis K-Ras ALK Overview ROS1 (gefitinib) EGFR ERBITUX XALKORI Plasma TARCEVA XALKORI ctdna VECTIBIX (erlotinib) (trastuzumab) (vemurafenib) (panitumumab) (crizotinib)(cetuximab) Buffy Coat & CTCs Red Blood Cells

18 OncoCEE Circulating Plasma Detection, analysis Buffy CTCs Red 16 Blood Capture Coat in CTC enumeration blood Cells Tumor ICC Testing or for Cells bone Protein and (CTCs) marrow cytogenetic/molecular FISH samples for Genes

19 CEE ctc Patented captured 17 Microfluidic arrangement CTCs Cells Channel can of posts be released optimized for further for ultra-sensitive analysis, including rare cell CEE-Selector capture Mounted mutation glass analysis, slide and transparent, is intended for enabling next generation direct microscopic sequencing visualization at Biocept of or captured with industry CTCs partners Multiple assays can be performed on

20 A OncoCEE Proprietary Not Captures Immediate Tests 18 New limited for Standard Breast, more post-capture CTC to Platform traditional CTCs Gastric, in antibody Oncology CellSearch biomarker Lung capture epithelial Diagnostics cancers (J&J) cocktail analysis CTCs Only Platform Single No Limited available biomarker capture to for traditional antibody Breast, analysis Colon, offered epithelial Prostate under CTCs FDA with clearance Colon, Prostate, Melanoma planned

21 Published Traditional 100 CTC?1 with of % 20 Positive 0 Breast (n=16) Tumor Biocept *Pecot 19 Cases 80 of 90 (n=30) Type et 70 CellSearch 10 Detection al, CTC Definition Cancer CRC Enumeration 30 (n=20) Discovery, of CTCs Prostate Comparison* (CK+, Dec. Lung 2011 CD45-, (n=22) DAPI+)

22 CK Traditional Biocept * 20 Mayer Positive/HER2+ Technology captures et al. definition Cancer more these Detects CK of Genetics, of types CTC Negative/HER2+ negative* of More >50% cells 2011 CTCs and of HER2 are considered Positive cells to be are a these CK due to antibody tumor cell cocktail and microfluidic CK negative cells missed by channel design competitors

23 Ground-Breaking Plasma CTCs Buffy B-Raf ZELBORAF (vemurafenib) VECTIBIX 21 Capture and Coat K-Ras ctdna cell CTCs EGFR (panitumumab) free (cetuximab) ERBITUX CEE-Selector ctdna Red Blood for IRESSA TARCEVA Genomic Cells Platform (gefitinib) Testing (erlotinib) & &

24 Advantages Mutation Allows Detects Works * 22 Biocept with for 1 determination mutation internal both various of CEE-Selector CTC data out nucleic and of sensitivity >10,000 cell acid free Platform targets normal ctdna x (DNA analysis better and than RNA) competing Compatible platforms* with sequencing and PCR instruments Multiplexing reduces costs and enhances reimbursement Potential applications in all stages of cancer

25 OncoCEE Italicized Product OncoCEE-BRTM Breast HER2, OncoCEE-GATM OncoCEE-LUTM ROS1, OncoCEE-CRTM Enumeration Currently OncoCEE-PRTM marrow) OncoCEE-METM 23 ER, Tumor and no Product mutations clinically of underlined Type CTCs, Prostate Enumeration Colon Lung Gastric Melanoma OncoCEE Profiles actionable AR, biomarkers PTEN and Enumeration of deletion CTCs, are of CEE-Selector of currently CTCs, (blood of CTCs ALK, EGFR HER2 available bone B-raf EGFR, K-ras, mutations and to K-ras, B-raf Biocept N-ras identified B-raf mutations customers mutations, ALK

26 Established CLIA CAP Automation 24 accredited inspected CLIA solutions for and Facility high certified in place complexity testing Manufacturing and lab operations in place Scalable for future growth Laboratory information system with client portal Adjacent clinical development and research facility

27 Targeted Raise Drive Build Publish Participate Deepen Expand 25 Market Develop awareness relationships OncoCEE studies payor strategic Commercialization directly key in medical relationships opinion with of adoption partnerships to with the oncologists major meetings leader value patient cancer and Strategy of speakers with advocacy / expand CTCs symposia centers pharma other and reimbursement groups physicians ctdna and biotech for coverage personalized diagnostics

28 Driving Salesforce current marketing Regionally team Managed Internal Leverage forces 26 team 2015 Adoption marketing care partner Plan for based 2016 expert pharma Commercial sales for Head Growth of sales Team and

29 Increasing Commercial Q2 Average reimbursement Q3 Adoption 2014 Samples Q4 100 Per 2014 per Quarter 50 sample YTD: $1,062

30 Revenue Utilize 28 Medicare Select Seeking Grow Establish Health Goal established clinical private economics and to Medicare new covers show Reimbursement payors trial revenue improved analysis CPT impact coverage business codes sources component outcomes CTC and for through other coverage capture, with of fee partnerships and testing reduced for today enumeration service costs Perform channels and Diversified analysis clinical revenue utility study streams against tissue biopsy

31 Clinical Columbia Patients Correlation Accepted Dana-Farber Metastatic CTC 22% Sponsored MD Published Recently 15% Current Other Four Additional Planned 29 Anderson of additional HER2 studies patients CTC Ovarian with Studies study diagnosed for in Breast by pending of positive Cancer and publication Genentech, ER peer were study Non positive 28% Cancer status studies breast Medicine patients, reviewed Her2 Small of CTCs DTCs patients metastatic Komen Biocept cancer pending positive with Cell published have collaborators detected April Lung predictive patients with Foundation OncoCEE on review and HER CTCs Cancer primary studies with discordance of but BR OncoCEE outcomes validating negative biopsy tm with primary with BR, metastatic on technology tissue placed primary biopsy and on tumor Herceptin primary biopsy

32 Biocept CEE-Sure Stability Transport Patent One and 30 associated US Portfolio pending Developed and CEE Tube associated Patented foreign Microfluidic Chemistry: Solutions pending OncoCEE patents Multiple Antibody Channel pending issued CEE-SelectorTM Mutation Cocktail for patents detection Patent in Analysis Two pending US and associated One US and associated foreign patents pending US, EU, China and foreign patents pending foreign patents pending Korea for capture; one US

33 Current (as Shares Outstanding Fully Average of Diluted 12/31/14 excluding Capital option exercise % Shares Common Structure exercise price Outstanding is Stock price $9.47/share shares 4,449,603 of 6,218,189 in $6.29 this offering) 72% 100% Equity Awards1 1,157,812 19% Warrants2 610,774 9%

34 Leading Sold * 32 Market 56% cap Cancer Cap to $2.84B* Roche close Diagnostic for of Market market $1.2B Companies Cap Market January $1.043B* cap 16, $241M* Sold 2014 to Sold Novartis $470M to GE Healthcare $576M

35 Investment OncoCEE : CEE-Selector : Commercialized path 33 market Highlights stage captures penetration tests enhanced cancer for circulating breast, diagnostics Established sensitivity gastric tumor company genomic research and cells certain (CTCs) with mutation collaborations lung ground-breaking cancers analysis and Test strategic technology pipeline partnerships focused platform on solid utilizing tumor a simple biomarkers blood in test lung, breast, colorectal, prostate and melanoma Established, certified and scalable CLIA lab Clear