Miniaturized, Multiplex, Point-of-Care Diagnostic Solutions

July 2018

2

Overview

� Disruptive Point of Care (POC) diagnostic technology positioned to replace central lab testing

� Targeting the $5 Billion autoimmune disease Market

� Strong IP position with 21 issued patents

� Multiple prototypes completed and multiple sample tests conducted

� 510(k) filing planned in two years

� Currently seeking $2M for an integrated prototype, preclinical studies

3

Management & AdvisorsManagement

� William R. Rassman, M.D. – CEO

Holds dozens of patents in medical devices, surgical technologies, and other fields. Built multiple business in medical, software and energy.

� David Ralin – CTOMultidisciplinary medical device and diagnostic assay developer. Built Maven’s technology to date.

Advisors

� Scott Mortimer, MBA - Business & Strategy Advisor Principal with Mirsona Consulting. Scott has held positions in portfolio business strategy, marketing and sales with Impax Labs, PDL BioPharma, MedImmune and Merck & Co.

� Dmitry Karayev, M.D., M.D. F.A.C.P., F.A.C.R. - Medical Director Center for Rheumatology Medical Group. Board certified Rheumatologist completed fellowship in Rheumatology and residency in Internal Medicine from Cedars-Sinai Medical Center and graduated medical school from Tufts University School of Medicine.

4

Diagnostic Opportunity� $54 billion global diagnostic

market

� $3.8 billion global autoimmune diagnostic market

� US autoimmune assay panel market: $633 million

� Point of care market is already 27% of the laboratory market and is growing at a rate of 9.3%Ø Most current POC are simple strip

tests

� Other significant market opportunities: infectious disease, veterinary ($3 billion), ex-US

Update #s

5

Current Diagnostic Needs � Autoimmune diagnosis is a cumbersome

multi-step / multi-day testing - reporting diagnosis – treatment cycle� Multiple rounds of office visits, blood tests

= time� Constantly waiting for results = anxiety � Weeks to Months and $100s to $1000s� Disease progression waiting for tests

� Lack of sensitive and specific testing equipment at Point of Care (POC). No financially feasible screening.

� No multiplex POC solutions available for MD office / desktop

Central Lab Draws or Office Draws Sample &Sends to Central Lab,

Physician & Patient Initiate Dx Request

df

Central Lab Processes Sample; Results Sent

To MD

Current Paradigm

6

Current Autoimmune Testing Needs

� Significant need for improved testing paradigm enabling earlier, faster, lower cost and more frequent diagnostic testing

� Autoimmune Diseases represent a significant medical and financial burden

� Estimated 10-35 million under-diagnosed – not tested

� Autoimmune disease costs more than cancer care

� These underdiagnosed Americans – need monitoring which will produce multiple yearly tests

� > 80 possible syndromes, > 90 specific auto-antigen tests

� Late diagnosis and treatment = acute syndromes = decreased mobility, destruction of thyroid, pancreas, myocardium, celiac function, kidneys, stroke, cascade to other organ systems

RA, + Citations

8

Polaron Platform Stage of Development

� Optical hardware and analytical software algorithms optimized, 6+ generations of readers

� Sensor and content sourcing industrialized

� Validated with manual and flow assays: nucleic acids, immunoassays, drug tests, cells

� Pilot autoimmune assays show excellent sensitivity, specificity, radical time and cost savings

� POC final form factor design pending

� Microfluidic immune assay cartridge will use commercial off-the-shelf micro-fluidic cassettes

Types TestingCompleted

DNA Yes

RNA Yes

Proteins Yes

Cells Yes

9

Maven LFIRE Proprietary Technology Platform

“LFIRE" - Label Free Internal Reflection EllipsometryReal-Time Polarimetric Imaging

Live Cell TestingProteins, DNA, etc.

10

Polaron Using LFIRE Diagnostic Technology� Maven’s sensor is a glass

surface that has a printed microarray with spots of protein molecules (antibodies or antigens)

� When a serum sample passes over this sensor surface, disease-specific antibodies binds to disease specific antigens.

� Maven’s technology reads the molecular thickness of the spots before, during, and after binding

� Because our technology can read the microarray, it can read the microarray for printing defects before the tests are run

12

*

Protein Array Immunoassay Amplification Principle

Maven Confidential

YAdd amplifying substrate

Immobilized antigens in spots on the microarray surface already have patient’s specific Disease antibodies, and confirming enzyme-labeled Antibodies as well

The substrate precipitates at the spot, amplifying the thickness by 100-fold.

Concept: Third Step “Amplify” signal for greater sensitivity

Y*

YYYY

Precipitate

13

INOVA (Werfen) Pilot #1Sm (lupus) Ag Only, 13 samples, IgG ELISA vs LFIRE Serum Screen

All 5 positive and 8 negatives agreed, ~proportional, semi-quantitative

6.5

6.0

5.5

5.0

4.5

4.0

3.5

3.0

2.5

2.0

1.5

1.0

0.5

0.0

Abso

rban

ce (O

D)

110

100

90

80

70

60

50

40

30

20

10

0

Phase Change (mRad)

N1 N3

SM1

SM2

SM3

SM4N4 N5

SM5

ELISA Signal LFIRE Signal

N6

RNP1

RNP2N2

SM2D

LowC

Low ControlELISA

LFIRE ControlSM2 - 15 fold Dilution

(Amplified)

(Label-free)

(Add references)

14

Comparing Commercial ENA Profile 5 ELISAs and LFIRETM

Semi-Blind. Tested 30 patient samples and compared Maven’s LFIRE results against a commercial ENA-5 ELISA IgG kit and Luminex

LFIRETM

+ -+ 26 1- 0 123

ELISA

Concordance > 99%

Analytical Sensitivity 96%

Analytical Specificity 100%

INOVA (Werfen) Pilot #2 ENA-5 Clinical Utility Summary

Economics:ELISA: ~$375 kit and 3+ hours, no screen, 5 tests x 9 stepsLFIRE: ~$45 materials and 45 minutes, 15+ tests, 5 steps only

Expandable to a >80 test full AID panel for pennies/test

15

SSB IgG

SNR ~675/nM

INOVA Pilot #2 ENA-5 Comparison of Maven’s Lfire, Elisa and Luminex

Cutofffor

positive>

Patient Serum ID Numbers

Note: SSB also had a surprising dynamic range.

Maven Confidential

Real Time Microarray Assay

IgM and IgG React at different rates

INOVA (Werfen) Pilot #2 ENA-5 Sm IgG, Serum 8171

17

� Flu Chip – QC – Label-Free View taken from drop of blood

Infectious Disease Model System

IgG low control

Patient SerumTotal IgGMeter

HARA

T0 before sample T5 “difference” after sample

Note: The array is made to fit within a 3.5mm footprint and is laid out in a way that is geometrically distinct. The qc image of the array is on the left, an example of response to serum on the right. The sample’s serum metering spots are quite active while it appears there is some human anti-rabbit IgG antibody present. Microfluidics can perform such a test on 50 nl of serum (there are 50,000 nl in a drop of blood)

18

Clinical Needs vs Technologies Maven is Multiplexing

Sensitivity Multiplexing

1.E-181.E-121.E-061.E+00

Classic Biochem

Maven LFIRE POC

Genalyte

Luminex

ELISA

Electrochemiluminescence (MSD)

0 100 200 300 400 500

g/mL of plasma tests per sample

19

Diagnostics: BiomarkersInterleukin 6Workflow matches traditional ELISA for simple adoption, ease of use.

VS

Print Slides

Blocking

Analyte

Detection Antibody

Streptavidin-HRP

DAB Substrate

Maven LFIRE Standard ELISA

Time Resolved Analysis

Coat Plates

Blocking

Analyte

Detection Antibody

Streptavidin-HRP

TMB Substrate

End Point Analysis

20

Polaron Positioning & Differentiation� The LFIRE system is the first and only desktop testing system to help

diagnose and manage critical autoimmune disorders in minutes

� Flexible and simple system for MD or office staff to operate at low cost and high accuracy

� While other systems require multiple chips or changing chips between tests, only Maven’s single chip reader enables low-cost and accurate reading of up to 220 tests with a single chip

Maven (Polaron) Genalyte(Maverick)

Athelas Orphidia

POC Site √ X √ √Low Cost √ XHigh Accuracy √ XRheumatology √ √ X XSmall Sample √ √ √ √Rapid Result √ √ √ √

21

Maven Cassette

<$$

Chip and Assay Content

Microfluidics

Instrument

<$$$$

Hardware Software

Maven Strategy� File as FDA Class 2 device via the 510(k) pathway

� Predicates to be used: Biorad 15-18 plex autoimmune profile

� Commercialize to large AID practices, integrated health systems� Enter consumer Health Service Account (HSA) market where patient

makes decision on blood testing expenditures: Expected ~$500B by 2020� Offer blood testing through pharmacies such as Walgreens, CVS, etc..

• Provider (M.D., Lab) $$$ panel• Consumer $$ / panel• Patient, Third Party Payor $-$$ / test

Revenue – Autoimmune Market

• Instruments have 30-60% Gross Margin• Consumables have huge Gross Margins on $125 Million (2.5% of market) annual sales (@ year 3)• Develop and enter other beach-head markets such as allergy, hematology, infectious disease, tropical

disease, drug testing, cancer markers, brain injury markers, and specialty ‘assay’ markets and many other markets

23

Maven Patent Portfolio

Patent Title Country & Filing Date

1. 6,594,011 Imaging Apparatus and Method US Jul 11, 2000 2. 6,587,617 Micro Lens Array for Bioassay US Feb 22, 2001 3. 7,023,547 Apparatus Including A Biochip For US Apr 19, 2001

Imaging of Biological Samples…. 4. 6,833,920 Apparatus and Method for Imaging US Jan 12, 2002 5. 162965 Apparatus and Method for Imaging Israel Jan 10, 2003 6. 6,859,280 Imaging Apparatus and Method US June 23, 2003 7. 6,882,420 Apparatus and Method for Imaging US May 7, 2004 8. 7,126,688 Microarray Scanning US May 17, 2004 9. 7,002,686 Apparatus and Method for Imaging US December 22, 2004 10. 7,193,711* Imaging Method and Apparatus US May 17, 2004 11. 7,518,724 Image Acquisition, Processing, & Display US December 29, 2005 12. 7,838,285 Imaging Electrophoresis System US April 24, 2006 Abandoned 13. 4219689 Imaging Apparatus and Method (Surface) Japan January 27, 2007 14. 7,867,783 Apparatus and Method for Performing US February 22, 2007

Ligand Binding Assays on Microarrays In Multiwell Plates (1st Vertical Wall Patent, Sidewall)

15. 7,863,037 Ligand Binding Assays on Microarrays US April 4, 2007 In Closed Multiwell Plates (2nd Vertical Wall, Single Post)

16. 7,799,558 Ligand Binding Assays on Microarrays US May 22, 2007 In Closed Multiwell Plates (2nd Vertical Wall, Arrayed Posts)

17. 8,039,270 Apparatus and Method for Performing US May 22, 2008 Ligand Binding Assays on Microarrays In Multiwell Plates (Microprisms)

18. 7,981,664 Apparatus and Method for Performing US May 22, 2008 igand Binding Assays on Microarrays In Multiwell Plates (3rd Vertical Wall)

19. 8,355,133 Biological Testing with Sawtooth--‐ US December 30, 2009 Shaped Prisms…..

20. 9,063,072 B1 Birefringence Correction System….. US June 23, 2015 21. * ZL200580024159.6 Imaging Apparatus and Method China

The related US patient is US Patent No. 7,193,711 issued on March 20, 2007

Strong Patent Portfolio

� 21 issued patents

� Maven holds trade secrets to maximize sensitivity

� New patent applications pending

24

Fundraising History� $10M funding to date

� Significant founder funding� NIH grant of $1.9M September 2010 (2 year grant)� William Rassman: $6.5 million� Other friends and family investors early in development� Company has no debt

� Currently Seeking $7-10M� $2M for development of robust prototype and validation in

Auto Immune Disease� Funds > $5-8M for FDA and CLIA waived status application

plus enable more rapid development of other disease testing platforms in parallel

25

Investment Summary� Game-changing POC multiplex diagnostic system aiming to meet significant Dx

market needs

� Initial target ~$5B market for Autoimmune disease diagnostics

� Develop other lab applications: Cancer markers (>100), Infectious disease (>100), Drug testing, Toxicology, Allergy, Tropical Diseases (third world applicatinos), Lipid Profiles for Consumers and other consumer focused tests, Battlefield & Space applications, etc….)

� Attractive razor/ razor blade model with low COGs� Enable strong economics for large integrated health systems to utilize and even single

specialty practices� Consumable priced at $15, each test priced at ~$0.05

� Significant development and de-risking undertaken to date in multiple successful platforms developed

� Raising $2M for prototype for validation (9 months)

� 510(k) filing planned by end 2020

26

Competitive OverviewMaven (Polaron)

Genalyte(Maverick)

Athelas Orphidia Karius

Platform Microfluidic chip/reader

Complex array of 12 chips [?]

Paper strip tests

Microfluidic chip

Infectious Disease focus Not POC

Site of Use POC – Exam Room

Office Laboratory

At home / POC POC Laboratory

No. of Tests 24 (?) – what is in 510(k) app (up to 220)

32 test (up to 128)

40 common tests

1,000 inf. Diseases

Focus Autoimmune Diseases

Rheumatology Cancer / Sepsis Infectious Disease

Stage Development Clin testing RA / SLE

Under FDA review

Development(Vapor, lol)

Development

Collection Amount

Finger prick Finger prick Finger prick Finger prick Full blood draw

Output Electronic

Speed < 15 min < 15 min 60 sec to result 24+ hours

Accuracy Robust Inconsistent

Cost / test [WHOSE?]

$12 / use [?][COGs, transfer, distrib, User,

~$200 / use

Must develop differentiated positioning vis a vis competition

Project Plan Overview, AskQ3 Q4 Q5 Q6 Q7 Q8 Q9

Product Launch – 2021

Concept, Planning

Alpha Prototyping

Prelim Assay Development

Beta Prototyping

Assay Transfer

Design for Manufacturing

Pilot Manufacturing

Verification and Validation

Equivalency Data Gen’n

Regulatory Package Prep’n

FDA Submission

Assay Dev: ID,Allergy, Hem, other

$2MM

$6MM

Maven Confidential

$12MM

Q1 Q2 Q3 Q4 Q52 Q6 Q7 Q8 Q9

$1.5MM

$2.5MM

28

Detailed Product Development Timeline2018 2019 2020 2021

29

William R. Rassman, M.D. williamrassman@gmail.com310-505-5383 cell

David Ralindavid.ralin@mavenbiotech.com

626-429-0632 cell

Maven Technologies, LLC2265 East Foothill Boulevard

Pasadena CA 91107