BIOC Presentation April 2014
20
The CEE Solu+on Personalized Medicine from a Liquid Biopsy
-
Upload
redchip-companies-inc -
Category
Healthcare
-
view
413 -
download
1
description
Transcript of BIOC Presentation April 2014
The CEE Solu+on Personalized Medicine from a Liquid Biopsy
Forward–Looking Statements
This presenta+on contains, and any accompanying oral presenta+on would no doubt contain, forward-‐looking statements, within the meaning of the Private Securi+es Li+ga+on 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 iden+fied by terms such as an+cipates, believes, could, es+mates, expects, intends, may, plans, poten+al, predicts, projects, should, will, would, or the nega+ve of those terms and similar expressions.
Forward-‐looking statements involve known and unknown risks, uncertain+es 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 presenta+on speak only as of the date hereof, and except as required by law, we assume no obliga+on to update these forward-‐looking statements whether as a result of any new informa+on, future events, changed circumstances or otherwise.
2
Business Overview
CLIA facility in San Diego, CA
Genomic test results sent to physicians
R&D
Clinical Development
CLIA Lab
R and D, test kits manufactured and samples analyzed
Manufacturing
3
Investment Highlights
• OncoCEE™: measures circula+ng tumor cells (CTCs)
• OncoCEE-‐BR™ : first commercialized test for breast cancer
• CEE-‐Selector™: pla\orm expansion for muta+on analysis
• Robust test pipeline focused on solid tumor genomic diagnos+cs including lung, breast, colon, prostate and melanoma
• Established, cer+fied and scalable CLIA lab
• Clear path to market penetra+on
• Established research collabora+ons and strategic partnerships
• IPO completed February 2014; gross proceeds of $19 million
4
Commercial stage cancer diagnos0cs company with ground-‐breaking technology pla9orm u0lizing a simple blood test
Mul+faceted Growth Strategy
• Commercializa+on – Clinical, Commercial – Biopharma – Partnerships
• Test Menu Build Out – test valida+on – Clinical u+lity studies – Pla\orm expansion
• Opera+onal Efficiency – Automa+on – Process improvements – Increase Gross Margin
5
Biocept Execu+ve Team
6
Michael Nall President and CEO
Lyle Arnold, Ph.D. SVP, R&D and CSO
Farideh Bischoff, Ph.D. VP TranslaEonal Research and Clinical Development
Bill Kachioff SVP, Finance and CFO
David Hale ExecuEve Chairman
• More than 25 years in healthcare sales, marke+ng and commercial opera+ons • 14 years in cancer diagnos+cs and genomics • Most recently GM N. American Sales and Marke+ng for Clarient, a GE Healthcare Company
• 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 • 39 issued US and 140 issued and pending patents worldwide
• Former Associate Professor and member, Cancer Center at Baylor College of Medicine • Postdoc at MD Anderson and Baylor College of Medicine • More than 130 peer reviewed papers and book chapters
• Chairman and CEO of Hale BioPharma Ventures with over 35 years as a healthcare visionary • Chairman of Santarus (acquired by Salix), Conatus, Micromet (acquired by Amgen), and SkinMedica (acquired by Allergan) • CEO of Hybritech (acquired by Lilly) , Gensia (acquired by Teva)
• More than 20 years life sciences experience • 14 years of experience in public company finance • Abboj Labs, Cutera, Coulter Pharmacue+cal, Althea, Vivus • Diverse finance and opera+ons management experience
Raaj Trivedi VP Commercial OperaEons
• More than 15 years in healthcare sales, marke+ng and business development • Served as VP of Marke+ng and then VP of Business Development at Clarient • Life Technologies Commercial Leader for Oncomine Biomarker Discovery Pla\orms
US Market Opportunity
7
Cancer Type
New Cases/ Year
Living with Cancer
Deaths/ Year
Breast 232,340 2,829,041 39,620
Prostate 238,590 2,617,682 29,720
Lung 228,190 399,431 159,480
Colorectal 142,820 1,154,481 50,830
Melanoma 76,690 921,780 9,480
Total 918,630 7,922,415 289,130
* Incidence, prevalence and deaths data provided by Na+onal Cancer Ins+tute: hjp://seer.cancer.gov/sta\acts/
Molecular Cancer Tes+ng Market
8
*GEN Magazine, Bold Predic+on for Future Cancer Tests *Frost and Sullivan – Market Research 2011 **Jain Pharma Biotech June 2011
CAGR 22.9% for US
0
0.5
1
1.5
2
2.5
3
2010 2015 2017
N. America*
Global**
$ Billions
Market Characteris9cs: • Increased reliance on molecular diagnos+cs for treatment decisions
• Expanding use of targeted therapies • Greater sophis+ca+on of oncology diagnos+cs
• Limited by need for tumor +ssue
Limita+ons of Tissue Biopsy
Cancer is a heterogeneous disease
– Molecular proper+es differ within a tumor
– Primary tumor biopsy may not reflect current disease condi+on
– Therapy causes changes in tumor cells
Biopsy is invasive
– May not be feasible based on pa+ent condi+on or tumor accessibility
– Imprac+cal for periodic monitoring for progression / recurrence
Biopsy +ssue is limited
– Greater demand due to molecular profiling
– Surgery is costly
9
Liquid Biopsy Addresses Limita9ons in Standard of Care
New Molecular Paradigm – Liquid Biopsy
• ctDNA -‐ CTCs – Circula+ng Tumor Cells, cell free Circula+ng tumor DNA
• ctDNA: demonstrated surrogate for tumor +ssue biopsy
• Can be captured and characterized for biomarkers, similar to +ssue
• Liquid biopsy repeatable throughout treatment, par+cularly when +ssue unavailable
• 66% of researchers say analysis of CTCs will be standard of care in the next 4 years*
10
*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 pa+ent treatment decisions
Breast cancer CTC
OncoCEE™ Personalized Genomic Diagnos+cs
11
Personalized Treatment
EGFR/ALK/ROS1 K-‐ras B-‐raf
ZELBORAF® (vemurafenib)
TARCEVA® (erlo+nib) & IRESSA® (gefi+nib) / XALKORI ®(crizo+nib)
ERBITUX® (cetuximab) & VECTIBIX® (panitumumab)
HER2
HERCEPTIN® (trastuzumab )
The Right Therapy for the Right Pa9ent at the Right Time
OncoCEE-‐BR™ Breast Cancer
OncoCEE-‐ME™ Melanoma
OncoCEE-‐CR™ Colorectal Cancer
OncoCEE-‐LU™ Non-‐small Cell Cancer
Intellectual Property
12
CEE-‐SelectorTM Muta+on Analysis Patent pending
Biocept Developed SoluEons
Patented CEE®
Microfluidic Channel
CEE-‐Sure™ Stability
Transport Tube Patent pending
OncoCEE™ Chemistry: An+body
Cocktail Patent pending
One US and associated foreign patents pending
Two issued US patents and two issued foreign patents; mulEple pending US and foreign patents
Two US and associated foreign patents pending for capture; one US and associated foreign patents pending for detecEon
One US and associated foreign patents pending
CEE-‐Selector™ Pla\orm
• Allows for both CTC and cell free ctDNA analysis • Detects 1 muta+on out of >10,000 normal DNA
• Works with various nucleic acid targets (DNA and RNA)
• Compa+ble with sequencing and PCR instruments
• Mul+plexing reduces costs and enhances reimbursement
• Poten+al applica+ons in all stages of cancer
13
MutaEon determinaEon sensiEvity 10-‐100x beSer than compeEng plaTorms*
* Biocept internal data
14
OncoCEE-‐BR™
2015 2013 2014
Product Valida9on-‐ CLIA Product Development-‐ R&D and TCD
OncoCEE-‐BR™ (DTC)
OncoCEE-‐PR™
OncoCEE-‐LU™
OncoCEE-‐CR™
OncoCEE-‐ME™
Breast cancer
Bone marrow for breast cancer
Prostate cancer
Non-‐small cell lung cancer
Melanoma
Colorectal cancer
HER2
OncoCEE-‐GA™ Gastric cancer
Product Development Pipeline
Muta9on FISH
ER PR
Pre-‐2013
15
OncoCEE™ Product Profiles
Product Tumor Type OncoCEE™ CTC CEE-‐Selector™
OncoCEE-‐BRTM (launched)
Breast Enumera+on of CTCs , HER2, ER, PR
Currently no clinically ac+onable muta+ons iden+fied
OncoCEE-‐GATM Gastric Enumera+on of CTCs, HER2 Currently no clinically ac+onable muta+ons iden+fied
OncoCEE-‐LUTM Lung
Enumera+on of CTCs, ALK, ROS1 EGFR, K-‐ras, B-‐raf muta+ons
OncoCEE-‐CRTM Colon Enumera+on of CTCs, EGFR K-‐ras, B-‐raf muta+ons
OncoCEE-‐PRTM Prostate Enumera+on of CTCs, AR, and PTEN dele+on (blood or bone marrow)
Currently no clinically ac+onable muta+ons iden+fied
OncoCEE-‐METM Melanoma Enumera+on of CTCs B-‐raf and N-‐ras muta+ons
16
Targeted Commercializa+on Strategy
• Raise awareness of the value of ctDNA
• Drive OncoCEE adop+on
– Market directly to oncologists
– Develop key opinion leader speakers
• Build rela+onships with pa+ent advocacy groups
• Publish studies with major cancer centers
• Par+cipate in medical mee+ngs / symposia
• Deepen payor rela+onships and expand reimbursement coverage
• Expand strategic partnerships with pharma and biotech for personalized diagnos+cs
17
Driving Adop+on for Growth
12 Month Commercial Team Build
• Head of sales and marke+ng
• Regionally based sales team
• Sales team for Pharma
• Managed care expert
• Internal marke+ng
• Leverage partner sales forces
18
Dana-‐Farber • Metasta+c Breast Cancer pa+ents with HER2 nega+ve primary biopsy • CTC HER2 posi+ve pa+ents, as detected with OncoCEE BR, placed on Hercep+n • Sponsored by Genentech • Results expected in 2014014
MD Anderson • Recently diagnosed breast cancer pa+ents • 15% of CTC and 28% of DTCs have HER2 discordance with primary tumor • Published in Cancer Medicine – April 20132013
Other studies • Four addi+onal peer reviewed published studies valida+ng technology • Addi+onal pending studies with collaborators • Planned study in Non Small Cell Lung Cancer • Planned study in Non Small Cell Lung Cancer
Clinical U+lity Studies
Investment Highlights
• OncoCEE™: measures circula+ng tumor cells (CTCs)
• OncoCEE-‐BR™ : first commercialized test for breast cancer
• CEE-‐Selector™: pla\orm expansion for muta+on analysis
• Robust test pipeline focused on solid tumor genomic diagnos+cs including lung, breast, colon, prostate and melanoma
• Established, cer+fied and scalable CLIA lab
• Clear path to market penetra+on
• Established research collabora+ons and strategic partnerships
• IPO completed February 2014; gross proceeds of $19 million
19
Commercial stage cancer diagnos0cs company with ground-‐breaking technology pla9orm u0lizing a simple blood test
The CEE Solu+on Personalized Medicine from a Liquid Biopsy
