Beacon Biomedical AIC Presentation

Easy, Accurate & Affordable Colorectal Cancer Screening

presented by:

Donald F. Weber, [email protected]

ColoRT™

Problem

EEEW!

YIKES!

Solution – ColoRT™

Traditional ELISA-Test

Point-Of-Care Test

ColoRT™

.

Technology

� Leveraging Decades of Research, Millions of Dollars and 24-Issued Patents

� Capital Efficient Business Model with Sustainable Market Advantage

� Dramatically Reduce Time & Cost to Market

1.625”

Patented Oncoprotein

Cripto-1Patented Device

Rapid Vertical Flow

Technology Validation

CRC

A.

Beacon-NIH Grant Validation

Viable

25-47%

Viable

75-92%

Viable

78-95%

Replication & Benchmark Study (60-90 Days)

91

57

99

CRC TestsCRC

Accuracy<90%

AA Sensitivity

46% <

Cost ($)<100

Sample Type

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Competitive Advantage

Offered

Colonoscopy

36% Colonoscopy

64%Refused

Colonoscopy

83%Took

Blood Test

15%

Took Fecal Test

2% Refused

Offered Alternative

Patient Preference

For Patients

• Most convenient

• Preferred sample

For Doctors

• Save lives through improved screening

• Reduces time / expense of follow-up

• Provides a revenue stream

For Payers

• Reduces systemic cost of cancer treatment

• Most cost effective solution

Stakeholder Benefits

“If ColoRT test can replace the use of an FIT for

screening my patients for advanced adenomas and

colorectal cancer, I would use it in a heartbeat.”

- Dr. Vafa Matin, Internist, CareMD

Stakeholder Testimonials

“My buddies and I have been talking about getting

screened for months, but we’re all dragging our feet.

If your test was available, I’d take it.”

- Eric M., Patient

“If Cripto-1 can detect advanced adenomas with decent

sensitivity, this is a game changer”

- Dr. R. Pamukcu, Gastroenterologist

CEO Midway Pharmaceuticals

ColoRT™ - CRC & Advanced Adenoma Screening

US:

• $1.2B, 24MM Patients, Noncompliant

• $3.5B, 69MM Individuals, Full Screen

EU:

• $4.0B, 114MM Patients, Full Screen

Future Cancer Screening

• Breast

• Lung

• Prostate, Ovarian, Pancreatic

Market

Intellectual Property:

• 24 – Issued Patents (Device & Chemistry)• World-wide Coverage• Addition of Future IP (Devices & Chemistries)

Regulatory:

• US - LDT > FDA 510(k) DeNovo, CLIA Waiver• EU - CE Mark

Reimbursement:

• Cash Pay > Private Payer > CMS• Both ELISA and POC Tests

Regulatory, Reimbursement & IP

Strategics

Time

FinancialMilestones $800M

(Seed / Grants)

1) ColoRT LDT

2) FDA Pre-sub

3) Device Prototype

M&A

$5.0M(Series B)

1) ColoRT EU

2) ColoRT US

3) BreastRT Test DevPortfolio

Milestones

Milestones / Timelines

2016 2017 2018 2019 2020

$3.0M(Series A)

1) ColoRT Clinical Study

2) Strategic Partnering

Financial Projections

Beacon Biomedical 2016 2017 2018 2019 2020

Number of Units Sold 3,000 67,000 701,000 2,220,000 3,893,000

Avg. selling price $25 $25 $32 $36 $37

Gross margin % 83% 83% 88% 88% 89%

Below in ($1,000s)

Revenues 580 2,331 23,163 80,183 146,703

Total Op Expenses $1,158 $5,283 $25,995 $58,441 $91,701

EBITDA -578 -2,952 -2,832 21,743 55,002

Cash Flow ($578) ($2,952) ($2,832) $15,872 $40,152

Product Drivers LDTs (CRC, BC) CRC Kits / POC BC POC

Milestone – Valuation Benchmarks

EXAS

$900 MM

VolitionRx

$79 MM

Beacon Biomedical

CE Mark, FDALDT, CE MarkEarly Stage

Epigenomics AG

$38 MM

Ma

rket C

ap

Team

● Donald F. WeberCEO & President

● F. Randall GrimesCOO

● Andreas Jeromin, Ph.D.CSO/PI

Advisors

● Dr. Adeyinka Laiyemo, MDHoward University.

● Dr. Robert Bowser, MDDignity Health/IronHorse Dx

● Dr. Kevin Jones, PhDMedMira, Inc.

● Mr. Dirk K. BethHyalescent Ventures

Use of AIC Proceeds

Q&

A

Donald Weber, [email protected]

ColoRT™

Specificity vs. Other Cancers

Recent Example:

Cologuard PMA Showed Positives for other Cancers

Non-Issue for FDA in PMA Review

Disease or Cancer

Specimens

Tested

Incident Rate per

10,000

% Positive

Coloquard

Hepatic Cancer 6 0.8 50%

Pancreas Cancer 12 1.2 41.6%

IBD 18 1 38.9%

Gynecological Cancer 11 2 36.4%

Rheumatoid Arthritis 15 4.1 26.7%

Stomach Cancer 8 0.8 25%

Lung Cancer 10 6.5 20%

Esophagus Cancer 11 0.5 18.2%

Bladder Cancer 17 2.3 17.6%

Cost Parity w/ FIT $91.19/Test*

Cost Parity w/ Cologuard $288.75/Test*

*Price point/test at which screening individuals with Beacon’s CRC Test would yield a cost/QALY on par with that of FIT and Cologuard for colorectal cancer (CRC ) cases detected w/ advance adenomas (AA), respectively.

$US

Reimbursement Economics

Clinical Trial Size

* Source: Epigenomics

Downstream Value Analysis

Value Chain Amount

A

Amount

B

Amount

CNotes

MSR Selling Price* $50 $75 $100Doctor’s Retail Charge to

Patient / Insurance

Beacon’s Selling

Price to Doctors*$25 $50 $75 Wholesale Pricing to Doctors

Doctors Profit $25 $25 $25 50% - 100% Gross Margin

COGS $4.25 $4.25 $4.25 83% -91.5% Gross Margin

NIH Licensing $1.25 $2.50 $3.75 NIH CR-1 license

MedMira

Licensing$1.00 $2.00 $3.00 Estimated at 4% of sales

Distribution $7.50 $7.50 $7.50 Estimated $7.50/unit

Total Costs $14.00 $16.25 $18.50 Exclusive of indirect costs

Beacon’s Net Profit $11.00 $33.75 $56.50 44% - 75.3% Net Margin

* Initial cost/benefit pricing parity analysis indicates a $54-$110 range to consumer could be potentially reimbursed. As such, prior

to product launch an adoption- pricing optimization assessment will be completed to insure Beacon is not under pricing its

wholesale cost to physicians/buyers.

24

US FDA Regulatory Pathway

Strategics

Industry Collaborators

MedMira POC Devices OEM

Mfg

Abcam Antibodies / Kit Mfg

IronHorse Dx /

Dignity Health

Assay Development

& LDT Launch

IHT Cancer POC Clinics

Academics / Institutions

Nat’l Inst. of Health. SBIR Grant

Award

Howard University SBIR

Collaborator

Boston University Grant

Collaborator

Advocates

Colon Cancer Alliance

EmpowHER

Hologic

Potential Licensees

A – Multi Nat’l Dx

B– Multi Nat’l Rx / Dx

C– Multi Nat’l Dx / Women’s

Health