Filed Pursuant to Rule 433

Issuer Free Writing Prospectus dated July 10, 2018

Registration Statement No. 333-225147

Corp o rate Over v iew

Ju l y 20 1 8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NASDAQ: BIOC

www.biocept.com

 

 


Forwar d - Lo o ki n g Stateme n ts

 

Th i s p r e s e ntation cont a i n s , and any a cc o m pany i n g or a l pre s e ntation wo u l d no do u bt c o n ta i n , f orward-look i ng statement s , with i n the m ea n ing o f t he P r i vate S e c ur i t i es L i t i g a t i on R e f orm Ac t o f 19 9 5, regard i n g Bi ocept, I n c . and our bu s ines s . Forward- l o o k ing s tatemen t s i n cl u d e a l l s t ate m ents th a t are not h is to r i c al f a c ts a n d gene r a ll y c an be i den t i f i e d by ter m s s u c h as anti ci p ates, be l ieve s , c o u l d, e s t i m ate s , e x pe c t s , i ntend s , m ay, p l an s , potent i a l , pred ic t s , pro j e c t s , s hou l d, w ill , wou l d, or the negat i ve of tho s e ter m s and si m il ar e x pre ssi on s .

Forward- l o o ki ng s t ate m ents invo l ve k nown and unknown r is k s , u n c ert a i nties and other fa c t ors t hat m ay c a u s e our a c tu a l r e s u l t s , p e r f or m an c e or a c h i eve m ents t o b e m ate r i a ll y different f rom any f u t ure re s u l t s , per f or m an c e or a c h i eve m ents e x pre ss ed or i m p li ed by the f orward- l oo ki ng s tatement s . For deta il s about the s e r isks , p l ea s e s ee our SE C f ili ng s . Al l forward- l o o ki n g s ta t e m e n ts c on t a i n e d i n this pr e s ent a t i on s p eak o n l y as o f the da te here o f , a nd ex c ept a s r e qu i red by l aw, we a s su m e no ob l igation to up d ate th e se f orwa r d- l o o ki ng s tatemen t s whether as a re s u l t of any new i n f or m at i on, f uture e v ent s , c hanged ci r c u m s tan c es or otherwi s e. Th i s p r e s e ntation d oes not con s t i t ute an o ffer to s e l l s e curit i e s i n cl u d i ng but n ot li m i t ed to w i t h i n a ny juri s d i ct i on in wh ic h the s a l e o f su c h s e curit i e s wou l d be u n l a w f u l . T h e i n f or m ation set f or t h he r ein has not been rev i ewed, approved or d is approved, nor has the a cc ura c y or adequa c y of the i n f or m at i on s et f orth here i n been pa ss ed upon, by the SE C or any s tate s e c urit i es ad m i n is trator.

The Company has filed a Registration Statement on Form S-1 (File No. 333-225147) (including a preliminary prospectus) with the SEC for the offering for which this presentation relates. The Registration Statement has not yet become effective. Before you invest, you should read the preliminary prospectus contained in the Company’s Registration Statement, any amendments or supplements thereto and other documents the Company has filed with the SEC for more complete information about the Company and this offering. The preliminary prospectus and the Registration Statement, as may be amended or supplemented from time to time, may be accessed through the SEC’s website at www.sec.gov. Alternatively, the Company or any dealer participating in the offering will arrange to send you the preliminary prospectus and any amendments or supplements thereto if you request it through Maxim Group LLC, 405 Lexington Ave, New York, NY 10174, Attn: Syndicate Department or by Tel: (212) 895-3745.  This presentation contains statistics and other data that has been obtained from or compiled from information made available by third party service providers. The Company has not independently verified such statistics or data. The information presented in this presentation is as of July 10, 2018 unless indicated otherwise.

 

2

 


Cor p o r ate Prof i le

 

CLIA – CAP accredited laboratory located in San Diego Patented technology used for liquid biopsy in cancer Providing actionable information to help physicians make  treatment decisions  NASDAQ: BIOC, Listed 2014 Market Cap: +/- $15M Shares Out: 68.5M ADTV: ~1,500K High concordance to tissue biopsy Collaborations and partnerships with renowned institutions Planned development of IVD kits for global distribution and use Biocept Completing the answer

 

3

 


In v e s tment High l ig h ts

 

Liquid Biopsy Market Estimated at $10+ Billion

 

Potential to improve cancer patient outcomes

 

Advantages of a simple blood test vs. tissue biopsy (convenience, repeatability, feasibility
benefits, reduced cost and fewer complications)

Test Menu Focused Only on Actionable Information

 

Unique CTC and ctDNA testing

 

Enables detection and monitoring of clinically-validated biomarkers listed in NCCN Guidelines

Industry-Leading Test Performance

 

Multiple clinical studies, publications, and presentations support Biocept’s proprietary Target
Selector™ platform

Opportunities for Value-Creating Strategic Partnerships

 

Potential for U.S. and Global Transactions

 

Commercial and Technology Partnerships

Strong Revenue Growth and Health Plan Reimbursement

 

4-year Revenue CAGR of 236%*

 

Indicative of platform validation and market potential

 

Cost-effective liquid biopsy testing

Evolution Toward Distributed Business Model

 

Actively growing Pathology Partnership (ie TC-PC) business

 

Target Selector Kits for both CTC and ctDNA platforms

*FY2014 through FY2017 and includes conversion to accrual revenue recognition in 1Q 2017

 

4

 


Anti c i p at e d Mil e s t o n es Ne x t 1 2 Months

 

Inc r ea s e mar k et pen e tration into eme r ging liquid biop s y s e gment

En t er into str a tegic c o mmer c ial and tech n ology pa r tner s h ips Global and U.S.

S ign addit i onal E mpower TC agreements with pathologis t s and major hos p i t als

  Validate Oncomine™ NGS Panel; Become Thermo Fisher Liquid Biopsy Center of Excellence

Grow sales of blood collection tubes under VWR marketing and distribution agreement

Sign new thir d - pa r ty health plan ag r eemen t s and expand r e lationship with B CBS

P ublish clinical ca s e studies

Lau n ch additional on c ology bioma r k e r a s s a ys

 

5

 


Patients Diagnosed with Cancer in the US

 

 

» O v er 1.68 m illi on new c an c er ca s es i n 2017

» Brea s t, l ung, and CRC a cc ount for >3 6 % of all new c ases of c ancer

» More than 610,000 p eop l e w il l d i e of c an c er i n 2017

» Brea s t, l ung, and CRC a cc ount for >4 1 % of all c ancer r elated deaths

»   S o u rc e: A m erican Cancer S o c i ety 2 0 17 SEE R S ta ti s t i c s

Estimated New Cases Prostate 161,360 19% Breast 252,710 30% Lung & bronchus 116,990 14% Lung & bronchus 105,510 12% Colon & rectum 71,420 9% Colon & rectum 64,010 8% Urinary bladder 60,490 7% Uterine corpus 61,380 7% Melanoma of the skin 52,170 6% Thyroid 42,470 5% Kidney & renal pelvis 40,610 5% Melanoma of the skin 34,940 4% Non-Hodgkin lymphoma 40,080 5% Non-Hodgkin lymphoma 32,160 4% Leukemia 36,290 4% Leukemia 25,840 3% Oral cavity & pharynx 35,720 4% Pancreas 25,700 3% Liver & intrahepatic bile duct 29,200 3% Kidney & renal pelvis 23,380 3% All Sites 836,150 100% All Sites 852,630 100% Estimated Deaths Lung & bronchus 84,590 27% Lung & bronchus 71,280 25% Colon & rectum 27,150 9% Breast 40,610 14% Prostate 26,730 8% Colon & rectum 23,110 8% Pancreas 22,300 7% Pancreas 20,790 7% Liver & intrahepatic bile duct 19,610 6% Ovary 14,080 5% Leukemia 14,300 4% Uterine corpus 10,920 4% Esophagus 12,720 4% Leukemia 10,200 4% Urinary bladder 12,240 4% Liver & intrahepatic bile duct 9,310 3% Non-Hodgkin lymphoma 11,450 4% Non-Hodgkin lymphoma 8,690 3% Brain & other nervous system 9,620 3% Brain & other nervous system 7,080 3% All Sites 318,420 100% All Sites 282,500 100%

 

6

 


Our Team has a Deep & Successful History of Commercializing Innovation

 

 

 

Michael Nall

President & CEO

 

• 25+ years in healthcare sales, marketing and commercial operations

• 16 years in cancer diagnostics and genomics

• Most recently General Manager N. American Sales and Marketing for Clarient — a GE Healthcare Company

 

 

 

 

 

Tim Kennedy

CFO & SVP of Operations

 

• 30+ years of financial experience, 25+ years in the clinical diagnostics industry

• Instrumental in 2.1B restructuring of Millennium Health, a privately-held urine drug lab

• Numerous senior management positions – helped transform PLUS Diagnostics into largest independent U.S pathology lab; merged National Health Labs and Roche Biomedical Labs to form LabCorp

 

 

 

 

 

Lyle Arnold, Ph.D.

SVP, R&D & CSO

 

• Senior R&D leadership at Gen-Probe, Incyte Genomics, Genta

• Founder/ Co-founder Oasis Biosciences, Molecular Biosystems, Aegea Biotechnologies

• Former faculty member, UCSD School of Medicine and member, UCSD Cancer Center

• 50 issued US and more than 160 issued and pending patents worldwide

 

 

 

 

 

Veena Singh, MD

SVP & Sr. Medical Director

 

• Board certified AP/CP and Molecular Pathology, UCSD, Cedars Sinai trained

• Numerous publications, serves on CAP committees

• Most recently Medical Director – bioTheranostics

 

 

 

 

 

Michael Terry

SVP, Commercial Operations

 

• 25+ years commercial leadership experience in molecular Dx and med-tech companies

• Former GE Healthcare executive, certified in Six Sigma

• Recent experience in liquid biopsy field; EVP commercial operations at both Sequenom and Trovagene

 

7

 


B i oce p t is Guid e d by a B o ard of V is i on a ries & Sc i entific In f l u enc e rs

 

 

Board of Directors

 

 

Clinical Advisory Board

 

 

David F. Hale

 

Bruce E. Gerhardt, CPA

 

Lee Schwartzberg, MD

 

David Carbone, MD

 

Chairman

 

Director, Member Audit Committee

 

Chief, Division of Hematology Oncology;

 

Director, James Thoracic Center, James

 

 

 

 

 

Professor of Medicine, University of

 

Cancer Hospital and Solove Research

 

 

 

 

 

Tennessee

 

Institute, Ohio State University

 

M. Faye Wilson, CPA, MBA

 

Ivor Royston, MD

 

 

 

 

 

Lead Independent Director, Chair

 

Director, Chair – Science and

 

 

 

 

 

Audit Committee, Member

 

Technology Committee, Member

 

Jenny Chang, MD

 

Michael Kosty, MD

 

Compensation Committee, Member

 

Nominating and Governance

 

Director, Methodist Hospital Cancer

 

Scripps Clinic Torrey Pines, San Diego

 

Nominating and Governance

 

Committee

 

Center, Houston, Texas

 

California

 

Committee

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Marsha A. Chandler, PhD

 

Bruce A. Huebner

 

Edgardo Santos, MD

 

Melissa Johnson, MD

 

Director, Chair - Nominating and

 

Director, Chair – Compensation

 

Medical Director, Lynn Cancer Institute,

 

Medical Oncologist, Nashville, Tennessee

 

Governance Committee, Member

 

Committee, Member – Science

 

Boca Raton, Florida

 

 

 

Science and Technology Committee

 

and Technology Committee,

 

 

 

 

 

 

 

Member – Audit Committee

 

 

 

 

 

 

 

 

 

Fred Hirsch, MD, PhD

 

Santosh Kesari, MD, PhD

 

Michael W. Nall

 

 

 

CEO, Int’l Assoc.of Study of Lung Cancer;

 

Chair, Dept. of Translational Neuro-oncology

 

Director, President & CEO

 

 

 

Professor of Medicine, University of

 

and Neurotherapeutics, John Wayne Cancer

 

 

 

 

 

Colorado

 

Institute, Santa Monica California

 

 

 

 

 

Scientific Advisory Board

 

 

David Berz, MD, PhD

 

 

 

Beverly Hills Cancer Center

 

 

 

David Rimm, MD, PhD

 

Marileila Garcia, PhD

 

Chief Medical Officer – Valkyrie

 

 

 

Professor of Pathology and Medicine

 

Professor, University of Colorado Division

 

Pharmacueticals

 

 

 

(Oncology) Yale University School of

 

of Medical Oncology

 

Beverly Hills, CA

 

 

 

Medicine

 

 

 

 

 

 

 

 

8

 


Pot e nt i al L i q u id Bio p sy Glo b al Ma r k e t Op p o r tu n ity

 

Liquid Biopsy market segments Today Emerging Future Future Profiling Monitoring Companion Diagnostics Screening including detection of asymptomatic patients ~$9B worldwide market by 2020* ~$2B worldwide market by 2020* ~$5B worldwide market by 2020* ~$7B worldwide market by 2020* “We sized the [global] market opportunity for liquid biopsy as $22B by 2020…” *J.P. Morgan Industry Report - May 27, 2015

 

9

 


Mole c ul a r Profi l ing of Canc e r Biomar k ers

The Sta n d a rd of C a re in P e rso n a l iz e d T re a tme n t

 

Target Selector Biopsy ctDNA CTCs Tissue Biopsy Personalized Molecular Assays Identification of Molecular Biomarkers Required to Qualify Patients for Targeted Therapy

 

10

 


Per s o n a l i z ed T r e atm e nt Imp r o v ed Out c om e s

 

5-Year Relative Survival By Year of Diagnosis (All Cancer Sites) 75.0% 70.0% 65.0% 60.0% 55.0% 50.0% 45.0% 40.0% 1975-1977 1978-1980 1981-1983 1987- 1989 1990-1992 1993-1995 1996-1998 1999-2001 2003-2006 2007-2013 2004 2013 the overall cancer death rate in the united stated fell by Evolution of Targeted Therapies for Cancer Treatment NCI Cancer Statistics https://seer.cancer.gov/csr/1975_2014/browse_csr.php?sectionSEL=2&pageSEL=sect_02_table.08.html   Herceptin Tarceva Erbitux Zelboraf Xalkori Gilotrif Tagrisso Keytruda Opdivo

 

11

 


Matching Cancer Patients to Personalized Therapy Remains Challenging

 

 

 

 

Lives are lost… Cancer proliferates… Time elapses… Treatment effective Treatment not effective Treatment not effective Treatment effective Dollars are wasted… Resources spent… Time elapses…

 

 

12

 


Legacy Cancer Diagnostic Tools Do Not Tell The Complete Story

 

 

 

Advantages

Disadvantages

Cost

 

 

 

 

 

 

 

Traditional Surgical Biopsy

 

Required for diagnosis

Considered standard of care

Source of cancer (histology)

Results for all known oncogenic alterations

Analysis of whole cells

 

Invasive – not appropriate for monitoring

Risk of adverse events

Expensive

Often inadequate for complete molecular

profiling

Only 57% of tissue biopsies have sufficient

tissue for analysis

Can take as much as 30 days for results

  Heterogeneity of tumor can lead to false

negatives

Does not account for evolving cancer over time

– snapshot view

 

 

 

 

 

 

 

 

 

 

 

 

 

$15,000 to $45,000

 

 

 

NGS Based Liquid Biopsy Panels

 

Real time

Non-invasive – appropriate for profiling

Faster availability of results

 

Cannot deliver information on all biomarkers

Varying sensitivity and specificity by biomarker

Expensive

Non-clinically actionable information

One size fits all approach – not individualized

Based solely on DNA fragments – ctDNA

Target market – medical oncology only

 

 

 

 

 

 

 

 

 

 

 

$6,800

 

 

13

 


Bio c e p t So l v e s the Pro b l e m by Com b i n i n g the Be s t of B oth W o r l d s

 

 

Target Selector Biopsy – Completing the Answer TM

 

The Biocept Advantage

 

 

 

      Combined results from whole cells (CTCs) and ctDNA from a single blood sample

 

 

 

 

 

 

 

 

 

 

 

      Enables results for all types of oncogenic alterations including SNVs, Indels, Fusions, CNVs, and Protein Expression

 

 

 

 

 

 

 

 

 

      Turnaround in 7 days or less enabling targeted therapy to move into frontline

 

  Cost = $1,200

 

 

 

 

 

 

      Individually validated all alterations – delivers high concordance with tissue

 

 

 

 

 

 

 

 

      Marketed as single tests or profiles enables personalized results for each patient

 

 

 

 

 

 

 

 

 

      Value – pay for individual and/or actionable alterations only

 

 

 

 

 

 

 

 

 

      Reimbursement advantages

 

 

 

 

 

 

 

 

 

      Addresses challenges of tumor heterogeneity

 

 

 

 

 

 

 

 

 

      Real time results versus static snapshots

 

 

 

 

 

 

 

 

 

      Non-invasive - appropriate for both profiling and monitoring

 

 

 

 

14

 


Patient Case Study – Biocept’s Testing Provides “The Gift of Time”

 

 

 

Biocept’s Target Selector Enables Personalized Treatment for Non-Small Cell Lung Cancer (NSCLC) Patient After Tissue Biopsy Proves Inadequate

 

 

 

Biopsy yields insufficient tissue for biomarker testing Jan 2014 Disease progression confirmed biopsy tissue insufficient for biomarker testing Nov 2014 Biocept’s liquid biopsy detects ALK Translocation Dec 1, 2014 Patient progresses liquid biopsy ordered Biocept liquid biopsy ordered again ALK not detected June 2016 3 cycle of chemo plus cyberKnife therapy completed May 2014 Crizotinib Nivolumab Female patient with history of cancer Jan 2014 Physician orders biocept EGFR and ALK liquid biopsy tests Nov 21, 2014 18months progression free survival on crizotinib June 2016 Patient continues to thrive after several rounds of personalized treatment      

 

 

15

 


Hig h ly Rel e v a nt T e s t M e n u :

In d ustry L e a d i n g Ass a y s T rust e d by C l i n ic i a n s, P a tie n ts, a n d P a y ers

 

 

15 Actionable Biomarkers Found in the Guidelines

 

Cancer

Target Selector CTC

Target Selector ctDNA

Breast

HER2*, ER*, FGFR1, AR, PDL1, PR*

ESR1 mutations

Gastric

HER2*, FGFR1

 

Lung

ALK*, ROS1*, MET*, FGFR1, PDL1*, RET

EGFR*, KRAS*, BRAF* mutations,

ALK mutations

Colon

EGFR amplification

KRAS*, BRAF*, NRAS* mutations

Prostate

AR , ARv7

 

Melanoma

 

BRAF*, NRAS* mutations

 

 * In NCCN guidelines

Biomarkers currently available for clinical use

Biomarkers under development

 

16

 


Industry-Leading Assay Performance

 

 

 

 

Controlled Validation Concordance (standard criteria) – 99.3%

 

CTC Biomarkers + ctDNA Analytical Validation

CTC Biomarkers + ctDNA Analytical Combined

 

Data Size (N)

 

4641

 

Accuracy

 

4610/4641 (99.3%)

 

Sensitivity

 

99.2%

 

Specificity

 

99.6%

 

 

 

Concordance to Tissue (real-world experience) - 87%

 

CTC Biomarkers + ctDNA Clinical Validation

CTC Biomarkers + ctDNA Clinical Combined

 

Data Size (N)

 

407

 

Accuracy

 

354/407 (87%)

 

Sensitivity

 

74%

 

Specificity

 

94.6%

 

 

17

 


Premier Commercial Platform

 

 

 

Completing the answer Biocept  26 issued patents  Comprehensive high- performance NCCN Test offering Evolution to Distributed Kit Model EmpowerTC  tm Pathology partner ship  Strong Growth Driven By Effective Commerical Team  Increasing  Reimbursement  Opportunity for cost leadership  

 

 

 

18

 


Differentiated Product Offerings

 

 

Company

CTCs / Whole Cells

ctDNA / DNA

Fragments

Proprietary

Collection Tube

Pathology

Partnership Strategy

Genomic Health

(GHDX)

 

 

 

Epic Sciences

(private)

 

 

 

Foundation

Medicine (FMI)

 

 

 

Guardant Health

(private)

 

 

 

Biocept (BIOC)

Biocept Advantage

 

Leading company commercializing both CTCs and ctDNA from a single blood sample

 

Demonstrated high concordance with tissue

 

Assays for most appropriate tumor target from blood for each biomarker

 

Blood more likely to contain intact cells and is less fragmented than other fluids such as urine

 

Broad, international patent coverage

 

Cost and reimbursement advantages  

 

19

 


Biocept IP Portfolio

 

 

 

Family 1

 

 

 

MicroChannel for CTC Capture

 

1) Issued in US with 11 international counterparts

 

   Patent 1 – Recovery of rare cells using microchannel

 

   China – Korea – China - France – Germany – Great Britain

 

   Patent 2 – Device for Cell Separation

 

Italy – Spain – Hong Kong – Japan – pending Aus. – Can.

 

 

 

2) Issued in US

 

 

 

 

 

 

Family 2

 

 

 

CTC Capture With Antibody Cocktail

 

1) Issued in US with 8 international counterparts

 

   Patent 1 – Devices & Methods of Cell Capture

 

   Aus. – France – Germany – Great Britain – Spain – Italy – Hong

 

Analysis

 

Kong - Japan – pending in Can - China

 

   Patent 2 – Method and Reagents for Signal

 

2) Issued in US, Japan, and China - 4 international cases

 

Amplification

 

pending

 

 

 

   Canada – Europe - Hong Kong –Korea

 

 

 

 

 

 

Family 3

 

 

 

Collection Tube

 

1) Issued in US

 

Patent 1 – Use of DU for Anti-Clumping of Biological

 

 

 

Sample

 

 

 

 

 

 

 

 

Family 4

 

 

 

Switch Blockers for ctDNA Analysis

 

1) Issued in US, Australia, and China with 4 international

 

Patent 1 – Methods for Detecting Nucleic Acid

 

counterparts

 

Sequence Variants

 

Europe – Japan – Hong Kong – Korea – Brazil

 

Extensive IP portfolio expected to allow Biocept to monetize IP through out-
licensing and moving to distributed model based on developing diagnostic kits

 

20

 


Market Development

 

 

Customer Focus

     Target select cancer center regions

     Focus on community oncologists (80% of cancer care)

     Partner with integrated delivery networks and local pathologists

Commercial team

     Experienced leadership

     Regionally based team with significant oncology sales experience

     Managed care expertise

Current Salesforce Coverage Sales Mgt. Sales Exec 14 NCCN Center direct sales representatives in the field

 

21

 


Commercial Adoption

 

 

     Executing on strategy to contract with major cancer treatment institutions, GPOs, and distributors

     Increasing patient access

     Accelerating adoption of liquid biopsy

     Leveraging sales and marketing resources by increasing awareness of Biocept’s liquid biopsy platform within large health systems

     Roll out new tests and service offerings including molecular pathology partnering model (ie ―TC-PC‖)

 

 

22

 


“AND” Campaign Debut at ASCO 2017

 

 

Biocept Completing the Answer Target Selector TM Liquid Biopsy Increasing Targeted Therapies via Liquid Biopsy eating cancer patients, it’s no longer an either/or world. At Biocept, we’re all about the AND… It’s time to consider molecular information from both tissue AND blood. Biocept is the industry’s first to offer cancer biomarker testing using both ctDNA AND CTCs. Focused on approved NCCN biomarkers, Biocept’s tests include targeted therapy AND immunotherapy markers. Visit Booth #25160 to learn about Biocept’s Liquid Biopsy Technology. www.biocept.com

 

23

 


EmpowerTC™ Launch at CAP 2017

 

Biocept Compelting the Answer TM Empower TC TM Tech-Only Liquid Biopsy Empowering Local Pathologists With World-Class Diagnostics the first in the industry to offer cancer biomarker testing using both ctDNA AND CTCs. Biocept offers specialized tests for approved nccn biomarkers, including targeted therapy and immunotherapy markes. Ctdna braf egfr kras nras ctc alk ar er fgfr1 her2 met pd l1 pr ret ros1 ctc count Our World-Class Lab. Your Expertise. Partner with Biocept for Tech-Only Services that combine our leading CTC Testing Technology with Your Local Knowledge. ALK Gene Rearrangement by FISH:DETECTED (1CTC/16 ml) Case Study:Biocept's liquid Biopsy Enables Personalized Treatment for Non-Small Cell Lung Cancer (NSCLC) Patient After Tissue Biopsy Proves Inadequate. Customer Service 888-332-7729 • FAX 877-300-1761 Biocept,Inc. 5810 Nancy Ridge Drive,San Diego, CA 92121 www.biocept.com C) 2017 Biocept.lnc.. All rights reserved. Target Selector is a trademark of Biocept,Inc. NCCN Guidelines is registered trademark of National Comprehensive Cancer Network, Inc... mktg-0036-02

 

24

 


 

Collaboration with Thermo Fisher Scientific

 

 

  Seek to Validate Thermo Fisher Oncomine™ NGS Panel in Biocept’s CLIA-certified laboratory

  Once validated, Biocept to be designated as Thermo Fisher Liquid Biopsy ―Center of Excellence‖ for oncology-focused liquid biopsy initiatives with the companies jointly pursuing various commercial opportunities

  Initially target the pharmaceutical industry to provide diagnostic testing services for drug development, clinical trial support, and companion diagnostics (CDx)

  Collaboration also intends to evaluate the feasibility of developing best-in-class products based on the integration of Biocept’s Target Selector™ technology with Thermo Fisher’s Ion Torrent™ NGS platform and Oncomine™ liquid biopsy-based NGS panels.

Thermo Fisher scientific Agreement in Place for Technology & Commercial Collaboration biocept completing the answer

 

25

 


Health Plan Access Continues to Expand with Third Party Contracts

 

 

 

  Managed Care agreements i n p l a c e c o v ering > 200 m i lli on liv es

  Ded ic ated managed c are l eadersh i p w i th y ears of e x perien c e from G E, LabCorp and Quest

  Pa y o r s have po si t iv e c overage for biomarkers listed in guidelines

  Aligns with goals of healthcare reform

  Improved outcomes while reducing costs

  Utilize established CPT codes

Multiplan imagine more… acpn America's Choice Provider Network fedmed bluecross blueshield stratose TM people analytics results medincrease health plans tm scripps three rivers trpn provider network galaxy health network fortified provider network biocept completing the answer

 

26

 


Deploying Capital To Fuel Accelerated Gro wth

 

 

 

Annual Revenue Development Commercial$5.5 $5.0 $4.5 $4.0 $3.5 $3.0 $2.5 $2.0 $1.5 $1.0 $0.5 $0.0 FY 2014 $0.1 FY 2015 $0.6 FY 2016 $3.2 FY 2017 $5.1 Annual Patient Samples 5,500 5,000 4,500 4,000 3,500 3,000 2,500 2,000 1,500 1,000 500 0 FY 2014 661 FY 2015 2,030 FY 2016 4,540 FY 2017 5,051 Commercial Development Research/Evals Note: FY 2017 includes $1.2M related to revenues recognized upon the receipt of payment. Biocept completing the answer

 

 

27

 


Biocept – Execution of Value Creation Strategy

 

 

  Investment in technology development of over $100M resulting in full commercialization

  Liquid Biopsy moving from early adopter orders to mainstream clinician orders for profiling.

  First liquid biopsy (plasma based EGFR testing) now in NCCN guidelines – will increase routine adoption (―AND‖ campaign)

  Early adopters now using for monitoring for response or progression indicating that the broader group will follow over coming year

  14 sales representatives in the field – driving deeper market penetration

  Only liquid biopsy company to market to oncologist and pathologist by providing value to both, with a goal of standardization at the institutional level

  Paid today by payors as coverage policies exist for Biocept menu, therefore generating revenue – per accession revenue of approx $1000 - $1200.

  At beginning of 2016, approx 5% of the cash needs provided by operations, 2017 approx 17%

 

Today Central Lab Collection Tube Commercialization Pathology Partnership 2018 IVD Kit Development 2019 Distributed IVD Kit Platform biocept completing the answer

 

 

28

 


 

Appendix

 

 

 

29

 


Patented Tar get Selector™ Platform Enables

both CTC and ctDNA Analysis

 

 

Benefits:

  CTCs obtained through our platform can be used to molecularly characterize tumor cells and evaluate changes in protein expression with the same techniques done in tissue.

  The same specimen can be microscopically analyzed for DNA and protein targets.

  All CTC tests are enumerated and can be used in monitoring applications.

Antibody Cocktail CTC Isolation CEE-Sure™ Blood Collection Tube for CTCs and ctDNA Patented Microfluidic Channel Detection, Enumeration and Biomarker Analysis all in the Channel FISH for Rearrangements Copy Number Variations ICC for Proteins Buffy Coat CTCS Plasma ctDNA Red Blood Cells

 

 

30

 


Patented Target Selector™ Platform Enables both CT C and ctDNA Analysis

 

Benefits:

       Performing PCR upfront and then sequencing delivers added confidence to final result.

       Switch-Blocker technology enriches oncogene mutations and suppresses wild type DNA resulting in ultra-high sensitivity and specificity.

       All ctDNA tests are quantitative and can be used to monitor mutation load.

       NGS technology allows multiplexing capabilities and future panel development.

Palsma ctdna buffy coat ctcs red blood cells DNA Isolation Patented Switch- Blocker Technology Multiplex Selector Enrichment PCR NGS Sanger Sequencing CEE-Sure™Blood Collection  Tube for CTCs and ctDNA  qPCR Mutation Detection

 

 

31

 


Biocept Publications, Posters, and Abstracts

 

 

 

42 Scientific/Clinical Presentations

       9 Peer-Reviewed Journal Publications and 3 Published Case Reports

       23 Poster Presentations at Leading Scientific/Clinical Meetings

       1 Technology Description

       6 Abstracts: Scientific/Clinical Meetings

 

 

32

 


Partners in Establishing Clinical Utility

 

 

       Collaborations with major cancer centers

       Participating in medical meetings and symposia

       Engaging KOL Advisors

       Building relationships with patient advocacy groups  

       Expanding strategic partnerships with pharma and biotech for personalized diagnostics

 

 

 

33

 


Landmark Clinical Trial for Liquid Biopsy

 

 

The Addario Lung Cancer Medical Institute (ALCMI) is an international research consortium driving clinical research via a world-class team of investigators from 25 member institutions in the U.S. UK, and Europe. It is supported by a dedicated centralized research infrastructure including standardized biorepositories and data systems.

 

      400 Lung Cancer Patients

      25 Treatment Sites (U.S. and International)

      1 Year Study Duration Evaluating Clinical Utility of Biocept Liquid Biopsy Testing

      Up to 2,400 Liquid Biopsy Data Points

      Key Endpoints:

      Demonstrate Concordance vs. Tissue

      Evaluate Response To Drug Therapy

      Identify Resistance Mechanisms

      Predict Treatment Failure Early

 

 

34

 


Achievements Since Going Public

 

 

Now

At IPO

      Revenue of $5.1M in FY 2017

$0 Revenue

      In-house billing and collections

Outsourced

      26 Issued Patents

1

      16 Members on Commercial Team (14 sales reps)

None

      Multiple health plan agreements signed including BCBS plans covering over 200M lives

None

      4 Pharma Agreements

None

      Nearly 30 ongoing clinical studies & numerous published papers and presentations at medical and scientific conferences

Less than 6

      Multitudes of patients helped

Minimal

 

 

 

35

 


 

Biocept

 

 

Contact: David Moskowitz, Investor Relations

Email: dmoskowitz@biocept.com; Phone: 858-320-8244

36

 

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