BioSig Technologies, Inc. (Form: 8-K, Received: 05/01/2020 12:30:35)

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 30, 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 April 30, 2020, BioSig Technologies, Inc. (the “Company”) issued a press release announcing that Dr. Jerome Zeldis, executive chairman and co-founder of the Company’s majority-owned subsidiary, ViralClear Pharmaceuticals, Inc., co-authored an article titled “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro.” The press release noted that the article was submitted to an online peer-reviewed life sciences journal. 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.

On May 1, 2020, the Company issued a press release announcing that the Company’s clinical team is due to resume patient cases at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas, as of May 4, 2020. A copy of this press release is filed as Exhibit 99.2 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 April 30, 2020
99.2		Press Release, dated May 1, 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: May 1, 2020	By:	/s/ Kenneth L. Londoner
		Name: Kenneth L. Londoner
		Title: Executive Chairman

Exhibit 99.1

ViralClear Submits In Vitro Data on Merimepodib and Remdesivir Synergistic Activity Against the COVID-19 Novel Coronavirus to a Peer-Reviewed Journal

Westport, CT, April 30, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) today announced that an article 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. The work was started with Trek Therapeutics and after merimepodib was acquired by ViralClear continued with ViralClear.

“The concentrations of merimepodib and remdesivir used in this article are achievable by our oral merimepodib and intravenous remdesivir.” said Dr. Zeldis, ViralClear’s Executive Chair and co-founder. “We look forward to starting our first Phase II clinical trial with merimepodid in COVID-19 patients upon receipt of FDA permission.”

Merimepodib, a broad-spectrum anti-viral candidate, demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. The molecule is currently undergoing extensive pre-clinical antiviral testing. Upon receipt of FDA permission of its IND, ViralClear intends to pursue development of this molecule for the treatment of COVID-19 through clinical trials in Q2 2020.

Remdesivir is an adenosine analogue that displays broad-spectrum antiviral activity against RNA viruses and has been developed by Gilead Pharmaceuticals for the treatment of Ebola. Recent evidence is mounting for this clinical activity of Remdesivir for treating COVID-19 patients.

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 ViralClear

BioSig’s subsidiary ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against COVID-19 in cell cultures. Merimepodib has been previously studied in 12 clinical trials, including 5 in patients with hepatitis C (1 Phase 1b, 1 Phase 2, 2 Phase 2a, and 1 Phase 2b), 1 in patients with psoriasis (Phase 2), and six in healthy volunteers (Phase I).

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.

Contact:

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations

54 Wilton Road, 2^nd floor

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

Exhibit 99.2

BioSig Resumes Clinical Activities with PURE EP System

●

Clinical support staff to return to perform elective procedures at Texas Cardiac Arrhythmia Institute as of May 4, 2020

●

Company reconfirms its commitment to commercial installations this year

Westport, CT, May 1, 2020 (GLOBE NEWSWIRE) --BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), 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, today announced that it plans to resume its clinical activities following the gradual return to elective procedures across the nation.

The Company’s clinical team is due to resume patient cases at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, TX, as of May 4, 2020 and is in active discussions with a number of other centers of excellence regarding the continuation of its clinical activities and initiation of new installations of PURE EP(tm) System.

“Our return to supporting cases is an important step for BioSig, and we have positioned ourselves for a strong transition back. We analyzed a tremendous amount of clinical data, conducted training and initiated a number of important physician engagement activities over the past two months. We now look forward to building on this work in the clinical setting and bringing PURE signals to more patients and physicians,” commented Julie Stephenson, BSN, MBA, Vice President of Clinical Affairs.

“The current pandemic had a profound impact on patients with cardiac arrhythmias, whose already debilitating conditions were likely to worsen due to cancellation or postponement of elective procedures. We sincerely appreciate the commitment of our physician collaborators, who continued to put patient needs first during these challenging times. We are grateful to be back in the field and to help the hospitals care for their patients,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

The Company initiated its first clinical trial in November 2019, and currently enrolls patients at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center and Mayo Clinic’s Florida campus. Earlier in 2019 the Company conducted observational patient cases at Indiana University School of Medicine, Greenville Memorial Hospital, Santa Barbara Cottage Hospital and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. The Company’s PURE EP(tm) System was used in over 120 procedures on patients with persistent atrial fibrillation, ischemic ventricular tachycardias, PVC, atypical flutters and other types of complex arrhythmias.