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Bringing Companion Diagnostics into the Clinic
Enabling Precision Medicine
2
 Cellgen is developing a bio-fluid based molecular diagnostic that
will serve as a cancer therapeutic guidance platform capable of
pushing companion diagnostic testing from reference labs into
clinics
 Headquartered in Irvine, CA with an RD lab in San Diego
 Technology exclusively licensed from UC San Diego
 Founded in October of 2012
 Technology transfer completed in June 2015
 Lean organization with 2 full-time and 2 part-time employees
Overview
3
Management Team  Key Advisors
Lavance Northington, MBA
Chief Executive Officer
Has successfully led several start-ups; Most
recently served as Founding President of
Soberlink
John Radak, CPA  MBA
Financial  Strategic Advisor
Former VP of Finance  Accounting of Life
Technologies; Former CFO of Quidel; Current CFO
of ArborGen
Gary Gust
Technology Officer
Previously held senior positions at Johnson 
Johnson and GenMark Diagnostics; Taken more
than a dozen devices through FDA approval
Robert Thompson
Strategic Advisor
Former CEO of e-Screen (sold to Alere); Current
CEO of Emerge Diagnostics
Yuhwa Lo, Ph.D.
Cellgen Technology Inventor
Professor of electrical and computer engineering
at University of California, San Diego; Director of
Nano3 and Calit2; Transferred over 15 different
technologies out of his lab
Sylvia Norman, Ph.D.
Scientific Officer
Previously held senior positions at Gen-Probe and
DermTech
Alex Khalessi. M.D.
Medical Advisor
Director of Endovascular Neurosurgery at
University of California, San Diego
4
Investment Opportunity
$775k investment to date
»» 2009-13: $550K of non-dilutive
grants in conjunction with UCSD
»» 9/2012: $100k ($2M pre-money)
»» 5/2013: $175k ($2M pre-money)
»» 5/2015: $500k ($3.8M pre-money)
Capital Efficient
»» Successfully transferred
technology from UCSD
»» Opened its RD lab in San Diego
»» Developed its LDT workflow
and commenced discovery
on its POCT platform
Use of proceeds
»» Certify CLIA lab and gain CAP
accreditation
»» Develop an alpha prototype of its
clinical EVAP platform
»» Hire additional technical 
commercial professionals
»» Provide 12 months of runway until
its Series A round
(planned for 2Q 2017)
$775K
 Cellgen is raising a $1M follow-on seed round with
»» a $10M pre-money valuation based on discounted cash flow and comparable company analyses (See MedDx Industry
Sector Analysis); and
»» a capital efficient business leveraging proven biology to lower overall investment risk
5
Valuation Drivers
 Cellgen embodies several of the prevailing trends currently impacting
clinical diagnostics
»» Multiple product roadmap
»» Strategic appeal for acquisition
»» Recognition that companion diagnostics are an essential element of personalized medicine
»» Companion diagnostics are key to sustainable cost containment
»» Migration of diagnostics to the point-of-care
Large strategics are following these trends closely as
evidenced in their corporate development initiatives
(acquisitions, partnering etc.)
6
Significant Value Creation
$450M $450M$203M $308M$275M
Main Driver:
Novel POCT
MDx Platform
Main Driver:
Novel MDx
Platform
Main Driver:
Novel Digital
PCR Platform
Main Driver:
Novel Protein
Research Tool
Main Driver:
Novel MDx
Platform
Targets capable of hitting key inflection points (technology
validation  FDA approval) will continue to receive much
attention and premium valuations from potential acquirers with
the potential to create immense value for shareholders
7
What Does Cellgen Sell?
Cellgen is developing a biofluid based, molecular diagnostic
platform that uses disposable cartridges to determine if a
patients genetic profile is a match for a particular cancer
therapeutic
8
What Makes Cellgen Different: Novel EVAP Technology
Clearly Disruptive
 Based on patent-pending evaporating droplet
technology
»» Amplification-free
»» Target flexibility: DNA including cfDNA, RNA
including exosomal miRNA  proteins
»» Quantitative, digital results in less than 5 hours
»» Target enrichment up to 500X
»» On-chip hybridization and detection
 Great promise for near-patient testing
Tecnolology System Cost Sample Type Technology Strengths Test Run Time Test Location Reimbursement
Cellgen Liquid
Biopsy CDx
$15K-$20K Bio Fluids
Evaporation/
Hybridization
Speed, Cost, Ease
of Use, Desktop
Footprint
4-5 hours Clinic Physician
Traditional Liquid
Biopsy CDx
$75K-$100K Bio Fluids PCR/ NGS
No Need for
Tissue Biopsy
7-10 days Reference Lab Reference Lab
Tissue Biopsy CDx $75K-$100K Tissue
PCR/ NGS/ FISH/
IHC
Industry “Gold
Standard”
Universally
Accepted
7-10 days Reference Lab Reference Lab
AMPLIFICATION
9
Cellgen’s Patent Pending Process
Pipetting DNA mixed with
buffer onto black silicone
chip with super-hydrophobic
surface and hydrophilic
micro islands
Sample Pipetting
10
Manual Workflow: Condense DNA on Micro Island Wells
Begin heating
Evaporating
Completely dried
11
Manual Workflow: Re-Suspension
Dipping in hybridization solution, creating homogenous nano-droplets throughout
the entire chip
Dip in hybridization solution to enrich
target up to 1 million times
12
Manual Workflow: Oil Immersion
Immerse the chip
into the oil to
create a controlled
hybridization
chamber for the
self-assembled
droplets
Oil	
Oil
13
Manual Workflow: Hybridization in Controlled Temperature
14
Manual Workflow: Washing
Submerge the chip into washing solution to wash away all un-hybridized DNAs and
Q-dots
15
Manual Workflow: Observation Under Microscope
Wafer	Chip	
Washing allows for the detection of individual binding events of each target DNA
marker
16
Manual Workflow: DNA Molecules Under the Microscope
Q-dot emission from target DNA (green) and non-specific binding or imperfect
wash (red) in high DNA copy number (left) and low DNA copy number (right).
The target DNA is the number of green spots subtracted from the number of
red spots.
17
The Problem: Current Therapies Fail Most Patients
“HEALTH CARE TODAY IS IN CRISIS AS IT IS EXPENSIVE, REACTIVE,
INEFFICIENT, AND FOCUSED LARGELY ON ONE-SIZE-FITS-ALL
TREATMENTS FOR EVENTS OF LATE STAGE DISEASE.”
						 —Ralph Snyderman, M.D., Chancellor Emeritus, Duke University
IMPRECISION MEDICINE
Abilify
aripiprazole
(Schizophrenia)
Advair Diskus
fluticasone propionate
(Asthma)
Nexium
esomeprazole
(Heartburn)
Enbrel
etanercept
(Psoriasis)
Humira
adalimumab
(Arthritis)
Remicade
infliximab
(Crohn’s disease)
Crestor
rosuvastatin
(High cholesterol)
Copaxone
glatiramer acetate
(Multiple sclerosis)
Cymbalta
duloxetine
(Depression)
Neulasta
pegfilgrastim
(Neurtopenia)
For every person they do help (blue), the ten highest-grossing drugs in the
United States fail to help most patients (red). Successfully helped Unsuccessfully helped
$350BEstimated Healthcare
Spend Wasted in 2011
Over
18
The Solution: Personalized Medicine
The right person, the right drug at the right time
Medicine Today
  Reactive
  Population-based
  One-size-fits-all model of care
Personalized Medicine
  Predictive
  Preventive
  Patient-centric model of care
Patients with unknown
disease sub-group
Unlikely to Respond
or Adverse Reaction
Likely to Respond
A
B
On Time,
Everytime
Genetic Match
19
Key Statistics
 42 percent of all drugs in the pipeline have a companion diagnostic
 Oncology leads the way with 73 percent of the pipeline represented by personalized therapies
 Biopharmaceutical companies nearly doubled their RD investment in personalized medicines over the
past five years, and expect to increase their investment by an additional one-third in the next five years
 Biopharmaceutical researchers forecast a 69 percent increase in the number of personalized medicines
in development over the next five years.
Personalized Medicine: At Its Tipping Point
Personalized Medicine is Transforming Cancer Care
73% of Cancer medicines
in the pipline have
the potential to be
personalized medicines
Biopharmaceutical companies focusing on personalized medicine has resulted in several recent approvals and a
growing number of new medicines in the pipeline
“ONCOLOGY IS ON FIRE WITH
[PERSONALIZED MEDICINE], WITH
TREATMENT SELECTIONS BASED
ON INDIVIDUAL MOLECULAR
CHARACTERISTICS. THIS IS ALSO
HAPPENING WITH CHRONIC
INFECTIOUS DISEASES, AND GENETIC
DISEASES ARE NOT FAR BEHIND”
		 —Janet Woodcock, Director
Center for Drug Evaluation and Research,
U.S. Food and Drug Administration
20
Personalized Medicine: Stakeholders Perfectly Aligned
Rx Company Benefits
  Accelerated FDA approvals
  Faster therapeutic adoption
  Decreased development costs
  Accelerated clinical trials cost
  Longer product life cycles
Patient Benefits
  Better outcomes
  Reduced trial and error prescribing
  Avoid adverse drug reactions
  Avoid over toxicity
“IN ORDER FOR ANY OF OUR DRUGS TO MOVE INTO CLINICAL DEVELOPMENT, THERE MUST
BE A BIOMARKER PLAN … TO DETERMINE WHICH BIOMARKERS CAN BE USED IN CLINICAL
DEVELOPMENT TO AID IN DECISION MAKING OR TO HELP IN PATIENT SELECTION”
				 —Nancy Simonian, MD
Chief Medical Officer, Millenium Pharmaceuticals
Physician Benefits
  Assay reimbursement
  New revenue center
  Reduced lab sendouts
  Faster clinical decisions
Payer Benefits
  Fewer unsubstantiated payouts
  Meaningful use initiatives meet
  Substantial financial savings
  Less over-prescribing of drugs
21
Companion Diagnostics are the Key to Personalized Medicine
“IN MOST CIRCUMSTANCES, IF USE OF AN IN VITRO COMPANION DIAGNOSTIC DEVICE IS ESSENTIAL FOR THE
SAFE AND EFFECTIVE USE OF A THERAPEUTIC PRODUCT, THE IVD COMPANION DIAGNOSTIC DEVICE AND
THERAPEUTIC PRODUCT SHOULD BE APPROVED OR CLEARED CONTEMPORANEOUSLY BY FDA FOR THE USE
INDICATED IN THE THERAPEUTIC PRODUCT LABELING” 							
														 —FDA
CDx
Companion diagnostics enable personalized medicine by
analyzing a patient’s DNA to determine if their genetics are a
match for a given drug
22
Current Companion Diagnostics Landscape
 Current CDx tests are specialized kits which run on
complex technology platforms and are focused on a
specific target type (DNA, RNA, Proteins)
 Consequently, all CDx testing is currently performed
away from patients in reference and specialty labs
preventing patients and clinicians from quickly
receiving valuable information
Even when a companion diagnostic is unequivocally required in drug labeling, not all doctors order testing for a variety of
reasons, including lengthy turnaround times for results and difficulty getting a tumor sample.
			 — GenomeWeb - February 2016
Current: 1-2 Weeks Average Turnaround Times
23
Cellgen Diagnostics: Changing the Companion Diagnostics Landscape
Physicians and patients
receive vital information
rapidly to avoid wasting
precious time
Cellgen: CDx Performed in the Clinic, Results in Hours
  Greatly improve patient outcomes by eliminating delays in
therapy selection, improving turnaround time from days to
hours
  Creates a significant new revenue opportunity
for physicians
  Drives increased commercial adoption of therapeutics,
particularly those from smaller Rx companies
  Incorporates machine learning to dynamically improve
prediction of therapeutic response
Cellgen’s EVAP platform will be capable of performing near-patient CDx assays, while at the same time sharing real time
data, across various clinical settings to enhance clinic decisions
24
Cellgen Diagnostics: Intelligent Therapeutic Guidance Platform
Cellgen’s companion diagnostics platform will provide 2 outputs:
  A Yes or No answer for a patient/drug genetic match decision
  If yes, a predictive therapeutic outcome value
»» Cellgen will quantify a signature of miRNA expression levels and place those expression levels into a set of machine
learning algorithms that will classify the patients likely response to the given medicine.  With every new patient, the
deep learning algorithms more specifically predict the therapeutic outcome of each patient.
Enhancing clinical decisions with machine learning
25
Companion Diagnostics Success
Zelboraf (Vemurafenib)
 Therapy for patients with metastatic
melanoma
 Targets BRAF V600E mutation which exists in
50-60% of melanomas
 In 2006, Plexxikon and Roche Molecular began
collaborating on development of a companion
diagnostic
 Therapy and companion diagnostic approved in
2011, just 4 months after FDA submission and
only 5 years after the initial IND filing
Xalkori (Crizotinib)
 Therapy for patients with non-small-cell lung
cancer
 Targets ALK gene rearrangements which occur in
3-5% of patients
 In 2009, Pfizer and Abbott Molecular began
collaborating on development of a companion
diagnostic
 Therapy and companion diagnostic approved in
2011, just 5 months after FDA submission and only
1 year after being granted fast track designation by
FDA
Industry-leading Pharma Companies Are Embracing CDx
26
An Immense Opportunity
Key Drivers
 Advanced technologies increasing the adoption of companion diagnostics
 Encouragement/requirements by regulatory bodies for companion diagnostics
 Increasing costs of traditional drug discovery
 Obvious benefits of companion diagnostics to all stakeholders
The global companion diagnostics market is expected to grow
at a 22.7% CAGR reaching $8.7 billion by 2019 Source: MarketsandMarkets
$8.7B
In 2019
~$4B
Now
“Companion Similar” Market Strategy
 Target (or duplicate) established EGFR-related companion diagnostic tests which is
already a significant market opportunity
 De-risk venture by removing lengthy and expensive biology clinical trials
 Simply validate proven EGFR Biomarkers on Cellgen platform
27
Cellgen Killer App: EGFR-related Cancer Companion Diagnostics
 EGFR is a gene mutation that is used as a therapeutic
response indicator for various cancers, particularly
lung cancer
 Epidermal Growth Factor Receptors (EGFR) mutations
are a common target of MANY drugs across various
cancer types, making EGFR the “killer” first piece of
content for Cellgen’s novel EVAP platform
 Focusing on existing EGFR-related CDx tests addresses
a signifcant slice of the $8.7B projected CDx testing
market
 Cellgen is in the process of developing and validating a
menu of EGFR CDx tests to launch commercial LDTs
Clear visibility to a robust menu of companion diagnostics content
Lung
Head
 Neck
Immuno Therapy
(Future)
Colon
Pancreatic
Thyroid
Breast
Other
28
A Winning Combination
Near-Patient
Capabilities
Yes None None None
Size Small Medium Large Large
Scope of Services Full Full Full Full
One Stop Shop Yes Yes Yes Yes
IVD/LDT IVD LDT LDT LDT
Preferred Sample Type Biofluids Biofluids Tissue Tissue
Target Flexibility
Many (DNA, RNA, Protein,
Exosomes)
Limited by technology
systems adopted
Limited Limited
Test Turnaround Time 5 hours 7-10 days 7-10 days 7-10 days
Cellgen combines the best characteristics of a leading CDx partner with a
proprietary POCT platform empowering clinician preference and increased
drug throughput
29
The Path Forward
Cellgen will follow a well established path to successfully
comercialize its groundbreaking EVAP Clinical CDx platform
Phase 1
(1-12 months):
Develop prototype 
open CLIA lab
Phase 2
(12-24 months):
Partner of choice for
pharma and research
labs
Phase 3
(24-36 months):
Generate revenue
from trials and
research as LDTs
Phase 4
(month 36):
Begin FDA approval
process
30
Strong Ongoing Collaborations Validate Our Solution
Plan to use of Cellgen’s EVAP
technology to validate assays
related to
  Protein Detection
  Bacterial Detection
Using Cellgen’s EVAP
technology to validate assays
across a diverse set of
infectious disease targets
  Bio terror
  Infectious disease
  Livestock
  Agricultural
  Veterinary
  Food safety
  Environmental
Promising discussions
regarding miRNA
applications of Cellgen’s
EVAP technology
  Lung cancer
  Breast cancer
  Colon cancer
  Glioblastoma
  Lymphoma  leukemia
31
Market Applications: Beyond Human Healthcare
Although Cellgen is focused on cancer markets, potential acquirers will be
attracted to its combination of full automation and diverse target detection
capabilities (DNAs, RNAs  Proteins) perfectly suited for large and growing
markets outside of healthcare
A key component to
delivering the many
promises of personalized
medicine. Key indications
include: depression, asthma,
cystic fibrosis,  HIV.
Allows for in-field testing
of various agricultural and
animal products
Rapid, on-site testing for
various harmful biological
and environmental agents
A simple system to power a broad
array of life science research
Healthcare Biothreat 
Environmental
Food Safety 
Agriculture
Basic Research
Lavance Northington
Chief Executive
lavance@CellgenDx.com
949-285-6888
Thank you

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Cellgen - Companion Diagnostic Platform

  • 1. Bringing Companion Diagnostics into the Clinic Enabling Precision Medicine
  • 2. 2 Cellgen is developing a bio-fluid based molecular diagnostic that will serve as a cancer therapeutic guidance platform capable of pushing companion diagnostic testing from reference labs into clinics Headquartered in Irvine, CA with an RD lab in San Diego Technology exclusively licensed from UC San Diego Founded in October of 2012 Technology transfer completed in June 2015 Lean organization with 2 full-time and 2 part-time employees Overview
  • 3. 3 Management Team Key Advisors Lavance Northington, MBA Chief Executive Officer Has successfully led several start-ups; Most recently served as Founding President of Soberlink John Radak, CPA MBA Financial Strategic Advisor Former VP of Finance Accounting of Life Technologies; Former CFO of Quidel; Current CFO of ArborGen Gary Gust Technology Officer Previously held senior positions at Johnson Johnson and GenMark Diagnostics; Taken more than a dozen devices through FDA approval Robert Thompson Strategic Advisor Former CEO of e-Screen (sold to Alere); Current CEO of Emerge Diagnostics Yuhwa Lo, Ph.D. Cellgen Technology Inventor Professor of electrical and computer engineering at University of California, San Diego; Director of Nano3 and Calit2; Transferred over 15 different technologies out of his lab Sylvia Norman, Ph.D. Scientific Officer Previously held senior positions at Gen-Probe and DermTech Alex Khalessi. M.D. Medical Advisor Director of Endovascular Neurosurgery at University of California, San Diego
  • 4. 4 Investment Opportunity $775k investment to date »» 2009-13: $550K of non-dilutive grants in conjunction with UCSD »» 9/2012: $100k ($2M pre-money) »» 5/2013: $175k ($2M pre-money) »» 5/2015: $500k ($3.8M pre-money) Capital Efficient »» Successfully transferred technology from UCSD »» Opened its RD lab in San Diego »» Developed its LDT workflow and commenced discovery on its POCT platform Use of proceeds »» Certify CLIA lab and gain CAP accreditation »» Develop an alpha prototype of its clinical EVAP platform »» Hire additional technical commercial professionals »» Provide 12 months of runway until its Series A round (planned for 2Q 2017) $775K Cellgen is raising a $1M follow-on seed round with »» a $10M pre-money valuation based on discounted cash flow and comparable company analyses (See MedDx Industry Sector Analysis); and »» a capital efficient business leveraging proven biology to lower overall investment risk
  • 5. 5 Valuation Drivers Cellgen embodies several of the prevailing trends currently impacting clinical diagnostics »» Multiple product roadmap »» Strategic appeal for acquisition »» Recognition that companion diagnostics are an essential element of personalized medicine »» Companion diagnostics are key to sustainable cost containment »» Migration of diagnostics to the point-of-care Large strategics are following these trends closely as evidenced in their corporate development initiatives (acquisitions, partnering etc.)
  • 6. 6 Significant Value Creation $450M $450M$203M $308M$275M Main Driver: Novel POCT MDx Platform Main Driver: Novel MDx Platform Main Driver: Novel Digital PCR Platform Main Driver: Novel Protein Research Tool Main Driver: Novel MDx Platform Targets capable of hitting key inflection points (technology validation FDA approval) will continue to receive much attention and premium valuations from potential acquirers with the potential to create immense value for shareholders
  • 7. 7 What Does Cellgen Sell? Cellgen is developing a biofluid based, molecular diagnostic platform that uses disposable cartridges to determine if a patients genetic profile is a match for a particular cancer therapeutic
  • 8. 8 What Makes Cellgen Different: Novel EVAP Technology Clearly Disruptive Based on patent-pending evaporating droplet technology »» Amplification-free »» Target flexibility: DNA including cfDNA, RNA including exosomal miRNA proteins »» Quantitative, digital results in less than 5 hours »» Target enrichment up to 500X »» On-chip hybridization and detection Great promise for near-patient testing Tecnolology System Cost Sample Type Technology Strengths Test Run Time Test Location Reimbursement Cellgen Liquid Biopsy CDx $15K-$20K Bio Fluids Evaporation/ Hybridization Speed, Cost, Ease of Use, Desktop Footprint 4-5 hours Clinic Physician Traditional Liquid Biopsy CDx $75K-$100K Bio Fluids PCR/ NGS No Need for Tissue Biopsy 7-10 days Reference Lab Reference Lab Tissue Biopsy CDx $75K-$100K Tissue PCR/ NGS/ FISH/ IHC Industry “Gold Standard” Universally Accepted 7-10 days Reference Lab Reference Lab AMPLIFICATION
  • 9. 9 Cellgen’s Patent Pending Process Pipetting DNA mixed with buffer onto black silicone chip with super-hydrophobic surface and hydrophilic micro islands Sample Pipetting
  • 10. 10 Manual Workflow: Condense DNA on Micro Island Wells Begin heating Evaporating Completely dried
  • 11. 11 Manual Workflow: Re-Suspension Dipping in hybridization solution, creating homogenous nano-droplets throughout the entire chip Dip in hybridization solution to enrich target up to 1 million times
  • 12. 12 Manual Workflow: Oil Immersion Immerse the chip into the oil to create a controlled hybridization chamber for the self-assembled droplets Oil Oil
  • 13. 13 Manual Workflow: Hybridization in Controlled Temperature
  • 14. 14 Manual Workflow: Washing Submerge the chip into washing solution to wash away all un-hybridized DNAs and Q-dots
  • 15. 15 Manual Workflow: Observation Under Microscope Wafer Chip Washing allows for the detection of individual binding events of each target DNA marker
  • 16. 16 Manual Workflow: DNA Molecules Under the Microscope Q-dot emission from target DNA (green) and non-specific binding or imperfect wash (red) in high DNA copy number (left) and low DNA copy number (right). The target DNA is the number of green spots subtracted from the number of red spots.
  • 17. 17 The Problem: Current Therapies Fail Most Patients “HEALTH CARE TODAY IS IN CRISIS AS IT IS EXPENSIVE, REACTIVE, INEFFICIENT, AND FOCUSED LARGELY ON ONE-SIZE-FITS-ALL TREATMENTS FOR EVENTS OF LATE STAGE DISEASE.” —Ralph Snyderman, M.D., Chancellor Emeritus, Duke University IMPRECISION MEDICINE Abilify aripiprazole (Schizophrenia) Advair Diskus fluticasone propionate (Asthma) Nexium esomeprazole (Heartburn) Enbrel etanercept (Psoriasis) Humira adalimumab (Arthritis) Remicade infliximab (Crohn’s disease) Crestor rosuvastatin (High cholesterol) Copaxone glatiramer acetate (Multiple sclerosis) Cymbalta duloxetine (Depression) Neulasta pegfilgrastim (Neurtopenia) For every person they do help (blue), the ten highest-grossing drugs in the United States fail to help most patients (red). Successfully helped Unsuccessfully helped $350BEstimated Healthcare Spend Wasted in 2011 Over
  • 18. 18 The Solution: Personalized Medicine The right person, the right drug at the right time Medicine Today   Reactive   Population-based   One-size-fits-all model of care Personalized Medicine   Predictive   Preventive   Patient-centric model of care Patients with unknown disease sub-group Unlikely to Respond or Adverse Reaction Likely to Respond A B On Time, Everytime Genetic Match
  • 19. 19 Key Statistics 42 percent of all drugs in the pipeline have a companion diagnostic Oncology leads the way with 73 percent of the pipeline represented by personalized therapies Biopharmaceutical companies nearly doubled their RD investment in personalized medicines over the past five years, and expect to increase their investment by an additional one-third in the next five years Biopharmaceutical researchers forecast a 69 percent increase in the number of personalized medicines in development over the next five years. Personalized Medicine: At Its Tipping Point Personalized Medicine is Transforming Cancer Care 73% of Cancer medicines in the pipline have the potential to be personalized medicines Biopharmaceutical companies focusing on personalized medicine has resulted in several recent approvals and a growing number of new medicines in the pipeline “ONCOLOGY IS ON FIRE WITH [PERSONALIZED MEDICINE], WITH TREATMENT SELECTIONS BASED ON INDIVIDUAL MOLECULAR CHARACTERISTICS. THIS IS ALSO HAPPENING WITH CHRONIC INFECTIOUS DISEASES, AND GENETIC DISEASES ARE NOT FAR BEHIND” —Janet Woodcock, Director Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • 20. 20 Personalized Medicine: Stakeholders Perfectly Aligned Rx Company Benefits   Accelerated FDA approvals   Faster therapeutic adoption   Decreased development costs   Accelerated clinical trials cost   Longer product life cycles Patient Benefits   Better outcomes   Reduced trial and error prescribing   Avoid adverse drug reactions   Avoid over toxicity “IN ORDER FOR ANY OF OUR DRUGS TO MOVE INTO CLINICAL DEVELOPMENT, THERE MUST BE A BIOMARKER PLAN … TO DETERMINE WHICH BIOMARKERS CAN BE USED IN CLINICAL DEVELOPMENT TO AID IN DECISION MAKING OR TO HELP IN PATIENT SELECTION” —Nancy Simonian, MD Chief Medical Officer, Millenium Pharmaceuticals Physician Benefits   Assay reimbursement   New revenue center   Reduced lab sendouts   Faster clinical decisions Payer Benefits   Fewer unsubstantiated payouts   Meaningful use initiatives meet   Substantial financial savings   Less over-prescribing of drugs
  • 21. 21 Companion Diagnostics are the Key to Personalized Medicine “IN MOST CIRCUMSTANCES, IF USE OF AN IN VITRO COMPANION DIAGNOSTIC DEVICE IS ESSENTIAL FOR THE SAFE AND EFFECTIVE USE OF A THERAPEUTIC PRODUCT, THE IVD COMPANION DIAGNOSTIC DEVICE AND THERAPEUTIC PRODUCT SHOULD BE APPROVED OR CLEARED CONTEMPORANEOUSLY BY FDA FOR THE USE INDICATED IN THE THERAPEUTIC PRODUCT LABELING” —FDA CDx Companion diagnostics enable personalized medicine by analyzing a patient’s DNA to determine if their genetics are a match for a given drug
  • 22. 22 Current Companion Diagnostics Landscape Current CDx tests are specialized kits which run on complex technology platforms and are focused on a specific target type (DNA, RNA, Proteins) Consequently, all CDx testing is currently performed away from patients in reference and specialty labs preventing patients and clinicians from quickly receiving valuable information Even when a companion diagnostic is unequivocally required in drug labeling, not all doctors order testing for a variety of reasons, including lengthy turnaround times for results and difficulty getting a tumor sample. — GenomeWeb - February 2016 Current: 1-2 Weeks Average Turnaround Times
  • 23. 23 Cellgen Diagnostics: Changing the Companion Diagnostics Landscape Physicians and patients receive vital information rapidly to avoid wasting precious time Cellgen: CDx Performed in the Clinic, Results in Hours   Greatly improve patient outcomes by eliminating delays in therapy selection, improving turnaround time from days to hours   Creates a significant new revenue opportunity for physicians   Drives increased commercial adoption of therapeutics, particularly those from smaller Rx companies   Incorporates machine learning to dynamically improve prediction of therapeutic response Cellgen’s EVAP platform will be capable of performing near-patient CDx assays, while at the same time sharing real time data, across various clinical settings to enhance clinic decisions
  • 24. 24 Cellgen Diagnostics: Intelligent Therapeutic Guidance Platform Cellgen’s companion diagnostics platform will provide 2 outputs:   A Yes or No answer for a patient/drug genetic match decision   If yes, a predictive therapeutic outcome value »» Cellgen will quantify a signature of miRNA expression levels and place those expression levels into a set of machine learning algorithms that will classify the patients likely response to the given medicine.  With every new patient, the deep learning algorithms more specifically predict the therapeutic outcome of each patient. Enhancing clinical decisions with machine learning
  • 25. 25 Companion Diagnostics Success Zelboraf (Vemurafenib) Therapy for patients with metastatic melanoma Targets BRAF V600E mutation which exists in 50-60% of melanomas In 2006, Plexxikon and Roche Molecular began collaborating on development of a companion diagnostic Therapy and companion diagnostic approved in 2011, just 4 months after FDA submission and only 5 years after the initial IND filing Xalkori (Crizotinib) Therapy for patients with non-small-cell lung cancer Targets ALK gene rearrangements which occur in 3-5% of patients In 2009, Pfizer and Abbott Molecular began collaborating on development of a companion diagnostic Therapy and companion diagnostic approved in 2011, just 5 months after FDA submission and only 1 year after being granted fast track designation by FDA Industry-leading Pharma Companies Are Embracing CDx
  • 26. 26 An Immense Opportunity Key Drivers Advanced technologies increasing the adoption of companion diagnostics Encouragement/requirements by regulatory bodies for companion diagnostics Increasing costs of traditional drug discovery Obvious benefits of companion diagnostics to all stakeholders The global companion diagnostics market is expected to grow at a 22.7% CAGR reaching $8.7 billion by 2019 Source: MarketsandMarkets $8.7B In 2019 ~$4B Now “Companion Similar” Market Strategy Target (or duplicate) established EGFR-related companion diagnostic tests which is already a significant market opportunity De-risk venture by removing lengthy and expensive biology clinical trials Simply validate proven EGFR Biomarkers on Cellgen platform
  • 27. 27 Cellgen Killer App: EGFR-related Cancer Companion Diagnostics EGFR is a gene mutation that is used as a therapeutic response indicator for various cancers, particularly lung cancer Epidermal Growth Factor Receptors (EGFR) mutations are a common target of MANY drugs across various cancer types, making EGFR the “killer” first piece of content for Cellgen’s novel EVAP platform Focusing on existing EGFR-related CDx tests addresses a signifcant slice of the $8.7B projected CDx testing market Cellgen is in the process of developing and validating a menu of EGFR CDx tests to launch commercial LDTs Clear visibility to a robust menu of companion diagnostics content Lung Head Neck Immuno Therapy (Future) Colon Pancreatic Thyroid Breast Other
  • 28. 28 A Winning Combination Near-Patient Capabilities Yes None None None Size Small Medium Large Large Scope of Services Full Full Full Full One Stop Shop Yes Yes Yes Yes IVD/LDT IVD LDT LDT LDT Preferred Sample Type Biofluids Biofluids Tissue Tissue Target Flexibility Many (DNA, RNA, Protein, Exosomes) Limited by technology systems adopted Limited Limited Test Turnaround Time 5 hours 7-10 days 7-10 days 7-10 days Cellgen combines the best characteristics of a leading CDx partner with a proprietary POCT platform empowering clinician preference and increased drug throughput
  • 29. 29 The Path Forward Cellgen will follow a well established path to successfully comercialize its groundbreaking EVAP Clinical CDx platform Phase 1 (1-12 months): Develop prototype open CLIA lab Phase 2 (12-24 months): Partner of choice for pharma and research labs Phase 3 (24-36 months): Generate revenue from trials and research as LDTs Phase 4 (month 36): Begin FDA approval process
  • 30. 30 Strong Ongoing Collaborations Validate Our Solution Plan to use of Cellgen’s EVAP technology to validate assays related to   Protein Detection   Bacterial Detection Using Cellgen’s EVAP technology to validate assays across a diverse set of infectious disease targets   Bio terror   Infectious disease   Livestock   Agricultural   Veterinary   Food safety   Environmental Promising discussions regarding miRNA applications of Cellgen’s EVAP technology   Lung cancer   Breast cancer   Colon cancer   Glioblastoma   Lymphoma leukemia
  • 31. 31 Market Applications: Beyond Human Healthcare Although Cellgen is focused on cancer markets, potential acquirers will be attracted to its combination of full automation and diverse target detection capabilities (DNAs, RNAs Proteins) perfectly suited for large and growing markets outside of healthcare A key component to delivering the many promises of personalized medicine. Key indications include: depression, asthma, cystic fibrosis, HIV. Allows for in-field testing of various agricultural and animal products Rapid, on-site testing for various harmful biological and environmental agents A simple system to power a broad array of life science research Healthcare Biothreat Environmental Food Safety Agriculture Basic Research