biosig20200909_8k.htm

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): September 9, 2020

 

BioSig Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

001-38659

26-4333375

(State or other jurisdiction

(Commission File Number)

(IRS Employer

of incorporation)

  

Identification No.)

 

54 Wilton Road, 2nd Floor

Westport, Connecticut

  

06880

(Address of principal executive offices)

  

(Zip Code)

 

(203) 409-5444

(Registrant’s telephone number, including area code)

 

                                       N/A                                        

(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:

 

☐ 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))

 

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

 

Title of each class

 

Trading Symbol(s)

 

Name of exchange on which registered

Common Stock, par value $0.001 per share

 

BSGM

 

The NASDAQ Capital Market  

 

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. ☐

 

 
 

 

Item 7.01             Regulation FD Disclosure.

 

On September 9, 2020, BioSig Technologies, Inc. (the “Company”) issued a press release, attached hereto as Exhibit 99.1, announcing that the Company’s majority-owned subsidiary, ViralClear Pharmaceuticals, Inc. (“ViralClear”), will host a call on Tuesday, September 22, 2020 at 11:00 AM Eastern Time to discuss ViralClear’s Phase 2 clinical trial evaluating the efficacy and safety of merimepodib (MMPD) in combination with remdesivir for hospitalized adult patients who have confirmed infection with SARS-CoV-2 and require non-invasive ventilation/high flow oxygen devices or supplemental oxygen. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.

  

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 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 Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination of such information is required by Regulation FD.

  

Item 9.01             Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number

 

Description

99.1

 

Press Release, dated September 9, 2020

104

 

Cover Page Interactive Data File (formatted as Inline XBRL)

 

 
 

 

SIGNATURES

 

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

 

 

 

 

 

 

 

 

Date: September 10, 2020    

By:

/s/ Kenneth L. Londoner 

 

 

 

Name: Kenneth L. Londoner

 

 

 

Title: Executive Chairman

 

 

 

 

 

 

 
NASDAQ false 0001530766 0001530766 2020-09-09 2020-09-09
ex_203316.htm

 

Exhibit 99.1

 

 

ViralClear to Host Conference Call on September 22, 2020, to Discuss Phase 2 Human Trial of AntiViral Merimepodib Oral Solution for Treatment of COVID-19

 

Westport, CT, Sept. 09, 2020 (GLOBE NEWSWIRE) --

 

 

●

Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Merimepodib in Combination with Remdesivir in Hospitalized Adults with COVID-19 Who Require Non-Invasive Ventilation/High Flow Oxygen Devices or Supplemental Oxygen

 

BioSig Technologies, Inc.’s (Nasdaq: BSGM) (“BioSig” or the “Company”) subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), today announced that it will host a conference call to discuss its Phase 2 clinical trial. The study is a randomized, double-blind, placebo- controlled trial evaluating the efficacy and safety of merimepodib (MMPD) in combination with remdesivir for hospitalized adult patients who have confirmed infection with SARS-CoV-2 and require non-invasive ventilation/high flow oxygen devices or supplemental oxygen (score of 3 or 4, respectively, on the NIAID 8-point ordinal scale). The trial is being conducted at 5 investigational sites across the United States (US), with Dr. Andrew Badley, the chair of Mayo Clinic COVID-19 Research Task Force serving as the study director.

 

Conference Call Details:

Date: Tuesday, September 22, 2020 Time: 11:00 AM Eastern Time (ET)

Dial in Number: 877-407-8293 / 201-689-8349.

 

A replay will be available for two weeks starting on September 22, 2020, at approximately 3:00 PM ET. To access the replay, please dial 877-660-6853 / 201-612-7415. The conference ID# is 13709930.

 

About BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

 

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

About Merimepodib and ViralClear

BioSig’s Technologies, Inc (Nasdaq: BSGM) subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms;

(iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Andrew Ballou

BioSig Technologies, Inc.

Vice President, Investor Relations

54 Wilton Road, 2nd floor

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

 

 

 

 
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Document And Entity Information
Sep. 09, 2020
Document Information Line Items  
Entity Registrant Name BioSig Technologies, Inc.
Trading Symbol BSGM
Document Type 8-K
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Document Period End Date Sep. 09, 2020
Entity Emerging Growth Company false
Entity Incorporation, State or Country Code DE
Entity File Number 001-38659
Entity Tax Identification Number 26-4333375
Entity Address, Address Line One 54 Wilton Road, 2nd Floor
Entity Address, City or Town Westport
Entity Address, State or Province CT
Entity Address, Postal Zip Code 06880
City Area Code (203)
Local Phone Number 409-5444
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Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Security Exchange Name NASDAQ