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): July 8, 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 8.01             Other Events

 

On July 8, 2020, BioSig Technologies, Inc. and its majority-owned subsidiary, ViralClear Pharmaceuticals, Inc. (“ViralClear”), issued a press release announcing that ViralClear is partnering with Albany Molecular Research Inc. (AMRI) for support in undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a standalone treatment or in combination with other anti-viral agents or immune modulators. A copy of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

  

Item 9.01             Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number

 

Description

99.1

 

Press Release, dated July 8, 2020

 

 

 

 

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: July 8, 2020    

By:

/s/ Kenneth L. Londoner 

 

 

 

Name: Kenneth L. Londoner

 

 

 

Title: Executive Chairman

 

 

 

 

 

 

 

Exhibit 99.1

 

 

 

ViralClear Pharmaceuticals partners with Albany Molecular Research Inc. on the manufacture of merimepodib active pharmaceutical ingredient development for the potential treatment of COVID-19

 

Westport, CT, July 08, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it is partnering with Albany Molecular Research Inc., (AMRI), a leading global contract research, development and manufacturing organization (CDMO), for support in undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a standalone treatment or in combination with other anti-viral agents or immune modulators.

 

“As part of our ongoing development and commercialization strategy we are delighted to be working with AMRI as our second US-based active pharmaceutical ingredient (API) supplier. The rapid transfer, scale up and validation of merimepodib API manufacture is key to our future supply chain and commercialization strategy,” commented Steve King, Chief Operating Officer, ViralClear. He continued, “ViralClear is committed to using US-based CDMOs for the development and commercialization of merimepodib.”

 

“AMRI is proud to partner with ViralClear in this vital effort of seeking a potential treatment for COVID-19,” said Christopher Conway, President, AMRI. “Our team is committed to applying the expertise and experience we’re renowned for to help combat this complex global health challenge.”

 

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 Viral Clear Pharmaceuticals, Inc. and Merimepodib (MMPD)

 

BioSig Technologies, Inc.’s (Nasdaq: BSGM) subsidiary, ViralClear Pharmaceuticals, Inc., 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. A manuscript titled, “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue Remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro”, was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. (“ViralClear”) as a corresponding author. This article highlights pre- clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.

 

About AMRI

 

AMRI, a contract research development and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in discovery, development, analytical services, and API and drug product manufacturing. www.amriglobal.com

 

 

 

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

 

AMRI

 

Kerry Hutchings

Kerry.hutchings@amriglobal.com