The CEE
Solution Personalized Medicine from a Liquid Biopsy
Issuer Free Writing Prospectus
Filed Pursuant to Rule 433
Registration No. 333-191323
Date: January 15, 2014 |
ForwardLooking 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 us (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 which 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 |
FWP Statement
3
This presentation highlights basic information about us and the offering to which this
communication relates. Because it is a summary, it does not contain all of the
information that you should consider before investing in our common stock.
We have filed a registration statement (including a prospectus, which currently is in
preliminary form) with the US Securities and Exchange Commission for the offering to
which this presentation relates. The registration statement has not yet become
effective. Before you invest, you should read the preliminary prospectus in the
registration statement (including the risk factors described therein) and other
documents we have filed with the SEC for more complete information about us and the
offering. You may access these documents for free by visiting EDGAR on the SEC
website at http://www.sec.gov The preliminary
prospectus, dated January 10, 2014, is available on the SEC Web site at
Alternatively, we or any underwriter participating in the offering will arrange to send you
the preliminary prospectus and, when available, the final prospectus and/or any
supplements thereto if you contact Aegis Capital Corp., Prospectus Department, 810
Seventh Avenue, 18th Floor, New York, NY 10019, telephone: 212-813-1010,
e-mail: prospectus@aegiscap.com |
Initial Public
Offering Summary 4 |
Business
Overview CLIA facility in
San Diego, CA
Genomic test results
sent to physicians
R&D
Clinical
Development
CLIA Lab
R&D, test kits
manufactured and
samples analyzed
5
Manufacturing |
Investment
Highlights
OncoCEE: measures circulating tumor cells (CTCs)
OncoCEE-BR
: first commercialized test for breast cancer
CEE-Selector: platform expansion for mutation analysis
Robust test pipeline focused on solid tumor genomic diagnostics
including lung, breast, colon, prostate and melanoma
Established, certified and scalable CLIA lab
Clear path to market penetration
Established research collaborations and strategic partnerships
6
Commercial stage cancer diagnostics company with ground-breaking
technology platform utilizing a simple blood test |
Biocept Executive
Team 7 |
US Market
Opportunity 8
*
Incidence,
prevalence
and
deaths
data
provided
by
National
Cancer
Institute:
http://seer.cancer.gov/statfacts/ |
Molecular Cancer
Testing Market *GEN Magazine, Bold Prediction for Future Cancer
Tests *Frost and Sullivan Market
Research 2011 **Jain Pharma Biotech June 2011
Market Characteristics:
Increased reliance on molecular diagnostics for treatment decisions
Expanding use of targeted therapies
Greater sophistication of oncology diagnostics
Limited by need for tumor tissue
9 |
Limitations of
Tissue Biopsy 10
Cancer is a heterogeneous disease
Molecular properties differ within a tumor
Primary tumor biopsy may not reflect current disease condition
Therapy causes changes in tumor cells
Biopsy is invasive
May not be feasible based on patient condition or tumor accessibility
Impractical for periodic monitoring for progression / recurrence
Biopsy tissue is limited
Greater demand due to molecular profiling
Liquid Biopsy Addresses Limitations in Standard of Care
Liquid Biopsy Addresses Limitations in Standard of Care
Surgery is costly |
New Molecular
Paradigm Liquid Biopsy
CTCs
Circulating Tumor Cells, ctDNA
Circulating tumor DNA
CTCs and ctDNA: demonstrated surrogate for tumor tissue biopsy
Can be captured and characterized for biomarkers, similar to tissue
Liquid biopsy repeatable throughout treatment, particularly when
tissue unavailable
66% of researchers say analysis of CTCs will be standard of care
in the next 4 years
*
11
*CTC industry overview
Hanson and Wade 2013
Solid tumors shed
CTCs and ctDNA
into blood
CTCs and ctDNA travel
via bloodstream
CTCs & ctDNA analyzed for
patient treatment decisions
Breast cancer CTC |
OncoCEE-BR
Commercially Available Breast Cancer Diagnostic
OncoCEE-BR
TM
, a simple blood test
Confirm tumor characterization (HER2, ER, PR)
Reduce false negatives
identify more patients for therapy
Monitor patient response to therapy
Detect metastasis, recurrence and biomarker conversion
Define tumor status to aid therapy selection when tissue not available
12 |
13
CEE Technology Overview
Farideh Bischoff, PhD
VP Translational Medicine |
The
OncoCEE Platform Solution
Isolate and analyze CTCs in Biocept CLIA lab
Significantly reduced no result
or non-reportable
cases due to
greater sensitivity and broader capture
On demand, current genomic status of tumor
Monitoring for drug efficacy and tumor recurrence
Enables improved patient outcomes at reduced cost of care
Can be adapted for wide range of cancer types
14
Simple blood test for prognosis, therapy selection and monitoring
for cancer patients
Personalized Biomarker Analysis |
OncoCEE
Personalized Genomic Diagnostics
15
EGFR/ALK/ROS1
K-ras
B-raf
ZELBORAF®
(vemurafenib)
TARCEVA®
(erlotinib)
&
IRESSA®
(gefitinib) /
&
XALKORI ®(crizotinib)
ERBITUX®
(cetuximab)
&
VECTIBIX®
(panitumumab)
HER2
HERCEPTIN®
(trastuzumab )
The Right Therapy for the Right Patient at the Right Time
OncoCEE-BR
Breast Cancer
OncoCEE-ME
Melanoma
OncoCEE-CR
Colorectal Cancer
OncoCEE-LU
Non-small Cell
Lung Cancer |
OncoCEE CTC
Testing 16
CTC Capture
ICC for Protein
FISH for Genes
Plasma
Buffy Coat
CTCs
Red Blood Cells |
CEE®
Microfluidic Channel
Patented arrangement of posts optimized for ultra-sensitive rare
cell capture
Mounted on glass slide and transparent, enabling direct microscopic
visualization of captured CTCs
Multiple assays can be performed on captured CTCs
Cells can be released for further analysis, including CEE-Selector
mutation analysis, and for next generation sequencing at Biocept
or
with industry partners
17 |
OncoCEE
Platform
CellSearch (J&J) Platform
Proprietary CTC antibody capture cocktail
Not limited to traditional
epithelial CTCs
Captures more CTCs
Single capture antibody
Limited to traditional
epithelial CTCs
Immediate post-capture biomarker analysis
No biomarker analysis offered
Developing tests applicable to broad range
of solid tumors
Only available for Breast, Colon, Prostate
OncoCEE
A New Standard in Oncology Diagnostics
18 |
Published CTC
Enumeration Comparison* Traditional Definition of CTCs (CK+, CD45-, DAPI+)
19
*Pecot et al, Cancer Discovery, Dec. 2011 |
Biocept Technology
Detects More CTCs 20
Traditional definition of CTC
Biocept captures more of these
due to antibody cocktail and
microfluidic channel design
Frequently, HER2 positive tumor cells are
CK negative
*
CK negative cells missed by competitors
Biocept captures these types of cells
*
Mayer et al. Cancer Genetics, 2011
CK Positive/HER2+
CK Negative/HER2+ |
21
CEE Selector Overview
Lyle Arnold, PhD
Chief Scientific Officer |
CEE-Selector
Platform (Launch Expected 2014) 22
CTC Capture
Plasma
ctDNA
Buffy Coat
CTCs
Red Blood Cells
EGFR
K-ras
B-raf
ZELBORAF®
(vemurafenib)
ERBITUX®
(cetuximab)
&
VECTIBIX®
(panitumumab)
TARCEVA®
(erlotinib) &
IRESSA®
(gefitinib) |
Advantages of
CEE-Selector Platform
Allows for both CTC and ctDNA analysis
Detects 1 mutation out of >10,000 normal DNA
Works with various nucleic acid targets (DNA and RNA)
Compatible with sequencing and PCR instruments
Multiplexing reduces costs and enhances reimbursement
Potential applications in all stages of cancer
23
Mutation determination sensitivity 10-100x better
than competing platforms*
*
Biocept internal data |
24
OncoCEE-BR
Product Validation-
CLIA
Product Development-
R&D and TCD
OncoCEE-BR
(DTC)
OncoCEE-PR
OncoCEE-LU
OncoCEE-CR
OncoCEE-ME
OncoCEE-GA
Product Development Pipeline |
25
OncoCEE
Product Profiles |
Established CLIA
Facility
CLIA inspected and certified
CAP accredited for high complexity
testing
Manufacturing and Lab Operations in place
Scalable for future growth
Laboratory Information System with client portal
Adjacent clinical development and research facility
26 |
27
Targeted Commercialization Strategy
Raise awareness of the value of CTCs and ctDNA
Drive OncoCEE-BR adoption
Market directly to oncologists
Develop key opinion leader speakers
Build relationships with patient advocacy groups
Publish studies with major cancer centers
Participate in medical meetings / symposia
Deepen payor relationships and expand reimbursement coverage
Expand strategic partnerships with pharma and biotech for personalized
diagnostics |
28
Driving Adoption for Growth
12 Month Commercial Team
Build
Head of sales and marketing
Regionally based sales team
Sales team for Pharma
Managed care expert
Internal marketing
Leverage partner sales forces
3 year sales team plan |
Reimbursement
Strategy
Utilize established CPT codes
Medicare covers analysis component of testing
Select private payors cover CTC capture, enumeration and
analysis
Seeking Medicare coverage for capture and enumeration
Diversify revenue streams
Grow clinical trial business and other fee for service channels
Establish new revenue sources through partnerships
Perform health economics studies against tissue biopsy
29 |
30
Clinical Utility Studies |
Intellectual
Property 31
Biocept Developed Solutions
One US and associated
foreign patents pending
Two issued US patents and
two issued foreign patents;
multiple pending US and
foreign patents
Two US and associated
foreign patents pending for
capture; one US and
associated foreign patents
pending for detection
One US and associated
foreign patents pending |
Use of Proceeds to
Drive Growth
Sales and Marketing investment to
commercialize test offerings (~$5 Million)
Research and Development, including
clinical utility studies, future test validation
and enhancements (~$5 million)
Operational Efficiency: automation and
scale up (~$3 million)
General and Corporate Purposes
32 |
Pre-IPO
Capital Structure 33
1
Assuming conversion of all preferred stock and convertible debt
to common stock.
2
Average option strike price of $5.13
3
Strike price is IPO price, assuming $11 |
34
Comparables
*
As of January 10, 2014 |
Investment
Highlights
OncoCEE: measures circulating tumor cells (CTCs)
OncoCEE-BR
: first commercialized test for breast cancer
CEE-Selector: platform expansion for mutation analysis
Robust test pipeline focused on solid tumor genomic diagnostics
including lung, breast, colon, prostate and melanoma
Established, certified and scalable CLIA lab
Clear path to market penetration
Established research collaborations and strategic partnerships
35
Commercial stage cancer diagnostics company with ground-breaking
technology platform utilizing a simple blood test |
The CEE
Solution Personalized Medicine from a Liquid Biopsy |