ARCA biopharma, Inc. (NASDAQ:ABIO) Files An 8-K Results of Operations and Financial Condition
Item 2.02.
Results of Operations and Financial Condition
As of December 31, 2018, ARCA biopharma, Inc. (“ARCA”) had cash and cash equivalents totaling $6.6 million (unaudited) and believes that these funds will be sufficient to fund its operations, at its projected cost structure, through the end of the second quarter of 2019.
The information furnished under Item 2.02 of this report shall not be deemed to be “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (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, as amended), or the Exchange Act, regardless of any general incorporation language in such filing.
Section8 — Other Events
On February 20, 2019, ARCA announced the U.S. Food and Drug Administration agreed to its Special Protocol Assessment for a single Phase 3 atrial fibrillation clinical trial and provided other program updates regarding its Gencaro product candidate.The press release related to these items is filed as Exhibit99.1 hereto, the contents of which are incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
Item 2.02. Financial Statements and Exhibits.
(d) Exhibits.
ARCA biopharma, Inc. Exhibit
EX-99.1 2 abio-ex991_6.htm EX-99.1 abio-ex991_6.htm Exhibit 99.1 ARCA Biopharma announces FDA agreement for a single Phase 3 clinical trial to support approval for the first genetically-targeted cardiovascular DrUG – FDA Special Protocol Assessment agreement granted for PRECISION-AF clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation in a heart failure population that has no FDA approved drug therapies – 58% treatment benefit seen versus active comparator in Phase 2B for planned Phase 3 target population – Gencaro development program has FDA Fast Track designation – U.S. and European cardiovascular patents and regulations may provide commercial exclusivity for Gencaro for 10 years post approval Westminster,…
To view the full exhibit click here
About ARCA biopharma, Inc. (NASDAQ:ABIO)
ARCA biopharma, Inc. (ARCA) is a biopharmaceutical company. The Company is principally focused on developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate is Gencaro (bucindolol hydrochloride), a beta-blocker and mild vasodilator that the Company is evaluating in a clinical trial for the treatment of atrial fibrillation (AF) in patients with heart failure with reduced left ventricular ejection fraction (HFREF). Gencaro is considered part of the beta-blocker class of compounds because of its property of blocking both beta-1 and beta-2, receptors in the heart. The blocking of these receptors prevents the receptor from binding with other molecules, primarily the neurotransmitter norepinephrine (NE), which activate these receptors. The Company is conducting a Phase IIB/III clinical trial of Gencaro, known as GENETIC-AF.