8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): April 23, 2013

ARCA biopharma, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware	000-22873	36-3855489
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

8001 Arista Place, Suite 430, Broomfield, CO 80021

(Address of Principal Executive Offices) (Zip Code)

(720) 940-2200

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Section 7 - Regulation FD

Item 7.01. Regulation FD Disclosure

ARCA biopharma, Inc. (the “Company” or “ARCA”) intends to conduct meetings with potential investors on or after April 23, 2013 through June 1, 2013. ARCA expects to use the presentation materials furnished as Exhibit 99.1 hereto, in whole or in part and possibly with immaterial modifications, in connection with such meetings. The fact that these presentation materials are being furnished should not be deemed an admission as to the materiality of any information contained in the materials. The information contained in the presentation materials is summary information that is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission and other public announcements that it may make, by press release or otherwise, from time to time.

The text of the presentation materials attached to this report may omit various graphic images included in the actual presentation materials. The Company expects to make copies of the presentation materials, including such graphic images, available for viewing at the “Investor Relations” section of its website located at www.arcabiopharma.com, although the Company reserves the right to discontinue that availability at any time.

The attached presentation materials contain “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the Company’s anticipated timing for initiation or completion of its clinical trials for any of its product candidates; the potential for Gencaro to be an effective potential treatment for atrial fibrillation and the Company’s ability to fund future operations. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; the Company’s ability to complete a strategic transaction to support the continued development Gencaro, and/or obtain additional financing; the Company’s anticipated timing for initiation or completion of its clinical trials for any of its product candidates; the Company’s ability to identify, develop and achieve commercial success for products and technologies; drug discovery and the regulatory approval process; estimated timelines for regulatory filings and the implications of interim or final results of the Company’s clinical trials; the extent to which the Company’s issued and pending patents may protect its products and technology; the potential of the Company’s clinical development program to lead to the approval of the Company’s New Drug Application for Gencaro; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2012, the Company’s Registration Statement on Form S-1 (Registration No. 333-187508), and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit Number	Description
99.1	Presentation dated April 23, 2013.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: April 23, 2013

ARCA biopharma, Inc. (Registrant)
By:	/s/ Christopher D. Ozeroff
Name:	Christopher D. Ozeroff
Title:	SVP and General Counsel

INDEX TO EXHIBITS

Exhibit Number	Description
99.1	Presentation dated April 23, 2013.

EX-99.1

Pioneering Genetically-Targeted

Cardiovascular Therapies

April 23, 2013

NASDAQ: ABIO

Exhibit 99.1

Safe Harbor Statement

2

This presentation contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform

Act of 1995.  These statements include, but are not limited to, statements regarding the Company’s anticipated timing for initiation or

completion of its clinical trials for any of its product candidates; the potential for Gencaro to be an effective potential treatment for atrial

fibrillation and, the Company’s ability to fund future operations. Such statements are based on management's current expectations and

involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements

as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and

whether they will be sufficient to meet the Company's business objectives and operational requirements; the Company’s ability to complete a

strategic transaction to support the continued development Gencaro, and/or obtain additional financing; the Company’s anticipated timing

for initiation or completion of its clinical trials for any of its product candidates; the Company's ability to  identify, develop and achieve

commercial success for products and technologies; drug discovery and the regulatory approval process; estimated timelines for regulatory

filings and the implications of interim or final results of the Company’s clinical trials; the extent to which the Company’s issued and pending

patents may protect its products and technology; the potential of the Company’s clinical development program to lead to the approval of the

Company’s New Drug Application for Gencaro; and, the impact of competitive products and technological changes. These and other factors

are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form

10-K for the year ended December 31, 2012, the Company’s Registration Statement on Form S-1 (Registration No. 333-187508), and

subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

Offering Summary

•

Ticker Symbol

ABIO

•

Offering

$20,000,000

Common stock + warrants

•

Use of proceeds

To fund Phase 2b development of Company’s

lead product candidate, Gencaro, working

capital and general corporate purposes

•

Placement agent

Dawson James Securities, Inc.

3

Corporate and Lead Product Highlights

•

Late stage cardiovascular company

•

Pharmacogenomic drug development/personalized medicine approach

–

Potentially first genetically-targeted cardiovascular drug

•

Experienced, successful management team

•

Lead

product

Gencaro

TM

(bucindolol

hydrochloride)

–

4

th

generation

beta-blocker

with

extensive

patient

data

–

1

st

potential

indication

-

atrial

fibrillation

(AF)

•

Clearly defined regulatory pathway

–

Similar endpoint basis for two most recent AF approvals

–

Beta blocker profile well characterized and understood

•

Significant

market

opportunities

in

a

major

unmet

medical

need

1

–

2.7 million AF patients in U.S.; 250,000-500,000 new onset AF/year (2010)

–

Current therapies associated with adverse events

•

Robust IP portfolio

–

US and EU market exclusivity, with potential patent extension, into 2029/2030

4

1

Bristow MR, Aleong RG. JACC-Heart Fail 1:29-30, 2013

ARCA biopharma Leadership

Michael

R.

Bristow,

MD,

PhD:

President

/CEO

Patrick

Wheeler,

Chief

Financial

Officer

Chris

Ozeroff:

General

Counsel

Thomas

Keuer:

EVP,

Pharmaceutical

Operations

Monique

Plamondon:

VP,

Regulatory/Quality

Board of Directors

Michael R. Bristow, MD, PhD

Jean-Francois Formela, MD

Linda Grais, MD, JD (Lead Independent)

Burton E. Sobel, MD

John Zabriskie, PhD

5

Pharmacogenomics:

The science of personalized medicine

6

Personalized medicine refers to the tailoring of medical treatment to the individual

genetic characteristics of each patient in order to classify individuals into subpopulations

that differ in their susceptibility to a particular disease or their response to a specific

treatment.  Preventative or therapeutic interventions can then be concentrated on

those who

will

benefit,

sparing

expense

and

side

effect

for

those

who

will

not.

1

Potential Benefits

Better diagnoses and earlier intervention

More efficient drug development

More effective therapies

Improved patient outcomes

Reduced adverse drug reactions

Reduced healthcare costs

Extension of market exclusivity

1 –

President’s Council of Advisors on Science and Technology, Priorities for Personalized Medicine, 2008

Patient Population Genotypes

Results from Phase 3 BEST trial DNA sub-study, HF endpoints

7

Source:  ARCA biopharma

‘Very Favorable’

genotype

{ß1 389 Arg/Arg + any

2C

}

~50%

‘Favorable’

genotype

{ß1

389 Gly carrier +

2C

Wt/Wt}

~40%

‘Unfavorable’

Pt. genotype

{ß1

389 Gly carrier +

2C

Del carrier}

~10%

1,040 Patients provided

DNA for sub-study

Target population

for Phase 2b/3 AF trial

Gencaro

Unique

MOA:

1)

NE

lowering

(Arg

is

NE

AR)

1

2) Inverse

agonism

2

1

Liggett  et al, PNAS 2006

2

O'Connor et al, PLOS ONE 2012

BEST trial participants

–

2,708 Patients –

LabCorp –

Strategic Partnership

•

ARCA has exclusive rights to

Gencaro companion genetic test,

has partnered with LabCorp

•

Easy-to-administer, one-time

genetic test

that identifies genetic

markers which predict clinical

response

•

Quick turnaround time for results

8

Strategic Partner

S&P 500 Company

$5.7B in revenues in 2012

34,000 employees worldwide

220,000 clients

Conducts over 1M tests daily

1

389 Arg/Arg (n =  441; 36 events)

Hazard Ratio = 0.26 (0.12 –

0.57)

P-value = 0.0003

Risk reduction 74%

BEST adrenergic receptor polymorphism substudy

Interaction p = 0.008

Prevention

of

new

onset

AF

in

BEST

by

1

389

Arg/Gly

genotype

Aleong et al, Circulation 124: A10438, 2011

1 -

Abi Nasr I et al, EHJ  28: 457–462, 2007

0.70

0.75

0.80

0.85

0.90

0.95

1.00

0

6

12

18

24

30

36

42

48

Months After Randomization

Placebo

Bucindolol

In a meta-analysis of Phase 3

HF trials covering ~12,000

randomized patients, there

was a 27%

average reduction

in incidence of new onset AF

in heart failure where new

onset AF was reported.¹

9

LVEF <0.50, Class II-III HF w/in 90 days

No contra-indications to

-blockers

1

389 Arg/Arg genotype

Bucindolol

Metoprolol CR/XL

ECV @  4 wks if still in AF

Phase 2b:  1°

Endpoint =  recurrent AF or ACM, 24 weeks; Co 1°

EP = AF burden

n =

100 (2b)

(Ph 3, 310)

n =

100 (2b)

(Ph 3, 310)

Phase 2b

Ph 3

Adaptive Design Superiority Trial

Bucindolol vs. Metoprolol CR/XL, Prevention of Recurrent Atrial Fibrillation in Persistent AF HFREF

Patients with the

1

389 Arg/Arg Genotype post Electrical Cardioversion (ECV), + Adaptive Design

to Phase 3

Projected timeline:

Trial Initiation –

Q4 2013

Ph 2b Trial Data –Q4 2015

Ph 3 Trial data-

Q4 2017

Time 0 (conversion to

AF counted as if ECV)

Ph 3 1°

EP: Recurrent  AF or ACM , 24 wks

10

Recent

onset Sx AF,

1 wk –

90 d

Class I-III HF

Strategic Partnership

-

GENETIC-AF Clinical Trial Collaboration-

•

Medtronic, Inc

–

World’s largest medical technology company

–

Leader in medical technologies to improve the treatment of chronic diseases,

including cardiac rhythm disorders

–

45,000 employees

–

$16 Billion –

2012 Revenues

–

$1.5 Billion –

2012 Research & Development Investment

•

Collaboration

-

Substudy of P2b portion of GENETIC-AF

-

Measure AF burden data by means of Medtronic continuous monitoring

devices

-

Medtronic to provide support for AF burden substudy and for collection and

analysis of substudy data

11

Medtronic and ARCA have executed agreement to collaborate on GENETIC-AF trial

Atrial Fibrillation

-

Regulatory Strategy -

Clearly defined Regulatory Pathway

–

Similar endpoints used for most recent AF FDA approvals

–

Safety profile –

well characterized based on BEST & prior development

–

Company has understanding of pathway, safety profile and trial design

12

Obtain an atrial fibrillation approval in a genotype specific heart failure  population

via adaptive design Phase 2b/3 trial of 200/620 patients

Possibility of approval, based on GENETIC-AF (Phase3) if   

p

0.01, when submitted with BEST trial data

Second trial will likely be required if GENETIC-AF p >0.01

•

•

•

Hatch-Waxman   

[5 years from

approval]

Hatch-Waxman

Patent Extension

[7.5 years from

approval]

EU Data Exclusivity

[10 –

11 years from EU

approval]

Bucindolol

Patents

[use of drug

w/ genetic

markers]

Bucindolol Market Exclusivity /

Intellectual Property Protection

13

Potential US Approval

Patent Expires

2029*

Worldwide Rights

Bucindolol Patents  Issued

US –

2010,11,12

Europe –2010

* 2029 US/2030

EU w/term extension from current terms of  2026/2025

Capital Structure

14

(as of December 31, 2012)

•

Shares outstanding:

2.66 million

•

Dilutive securities outstanding:

1.68 million

–

Stock issued post 12/31/12:

521K

–

Warrants outstanding:

930K (at $9.10 on weighted average)

–

Options outstanding:

144K (at $18.29 on weighted average)

–

Shares under Equity Plan:

80K

•

Current stock price (4/10/13):

$2.20 /share

•

Current market capitalization:

$7.01 million

•

Net cash:

$2.92 million

Summary

•

AF is an epidemic CV disease afflicting ~2.7 million patients & growing;

•

Significant unmet need for treatment/prevention of AF, particularly in

HFREF patients, and for rate control in HFREF (no other approved

drugs

for HFREF patients)

•

Prior clinical data have indicated Gencaro to be safe and has shown 

potential treatment benefits in AF, both in the entire patient cohort, and

especially in the "very favorable" genotype (~50% of patient population)

•

Management team with extensive experience in CV disease, drug

development and corporate execution

•

Potential to be only beta-blocker indicated for AF prevention

•

Potential to be the first genetically-targeted AF treatment

15