8-K 1 abio-8k_20190508.htm 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): May 8, 2019

ARCA biopharma, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware | 000-22873 | 36-3855489
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.)
11080 CirclePoint Road, Suite 140, Westminster, CO |  | 80020
(Address of Principal Executive Offices) |  | (Zip Code)

Registrant’s Telephone Number, Including Area Code: (720) 940-2200

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 Instructions 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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Securities registered pursuant to Section 12(b) of the Act:

Title of each class | Trading Symbol(s) | Name of each exchange on which registered
Common | ABIO | Nasdaq Capital Market

Section 2 — Financial Information

Item 2.02. | Results of Operations and Financial Condition.

On May 8, 2019, ARCA biopharma, Inc. (“ARCA”) issued a press release reporting financial results for the quarter ended March 31, 2019.

The press release is attached hereto as Exhibit 99.1, which is furnished under Item 2.02 of this report and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.

Section 8 — Other Events

Item 8.01. | Other Events.

On May 8, 2019, ARCA biopharma, Inc., or ARCA, made a presentation available regarding a business update, which is attached hereto as Exhibit 99.2, and the contents of which are incorporated herein by reference.

Caution Concerning Forward Looking Statements

This Current Report on Form 8-K and attached presentation may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding potential future development plans for Gencaro, including our ability to secure sufficient financing to support the anticipated Phase 3 clinical trial of Gencaro, the likelihood that any Phase 3 clinical trial results for Gencaro to satisfy the requirements of ARCA’s Special Protocol Assessment agreement, the expected features and characteristics of Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro or AB171, Gencaro’s potential to treat atrial fibrillation, or AF, future treatment options for patients with AF, the potential for Gencaro to be the first genetically-targeted AF prevention treatment, statements regarding the potential market size of any of ARCA’s product candidates, if approved, statements regarding potential Phase 3 development plans for Gencaro, including the timing and results thereof, the expected features and characteristics of AB171 as a potential genetically-targeted treatment for peripheral arterial disease and for heart failure, or HF, the potential timeline for development of AB171, including any Investigational New Drug, or IND, application submission related thereto, and the ability of ARCA’s financial resources to support its operations through the third quarter of 2019, the sufficiency of ARCA’s current capital to reach certain of its corporate objectives, ARCA’s ability to obtain additional funding when needed or enter into a strategic or other transaction, including its ability to raise sufficient capital to fund any Phase 3 clinical trials for Gencaro and its other operations, the extent to which ARCA’s issued and pending patents may protect its products and technology, the potential of such product candidates to lead to the development of safe or effective therapies, ARCA’s ability to enter into collaborations, ARCA’s ability to maintain listing of its common stock on a national exchange, ARCA’s future operating expenses, ARCA’s future losses, ARCA’s future expenditures, and the sufficiency of ARCA’s cash resources to maintain operations. These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2018, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements

Section 9 — Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number |  | Description
99.1 |  | Press Release titled “ARCA biopharma Announces First Quarter 2019 Financial Results and Provides Corporate Update” dated May 8, 2019.
99.2 |  | Investor Presentation titled “ARCA biopharma Pharmacogenetic Precision Medicine for Cardiovascular Diseases” dated May 8, 2019.

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: May 8, 2019 |
| ARCA biopharma, Inc.
| (Registrant)
| By: | /s/ Brian L. Selby
|  | Name: | Brian L. Selby
|  | Title: | Vice President, Finance and Chief Accounting Officer